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gabapentin 600 mg Tablet, 500-count — NDC 68382-0607-05 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

gabapentin 600 mg Tablet, 500-count — NDC 68382-607-05 (Billing 68382-0607-05)

by Zydus Pharmaceuticals USA Inc. · 500 TABLET in 1 BOTTLE

This is a package of 500 tablets of gabapentin 600 mg Tablet from Zydus Pharmaceuticals USA Inc., marketed since Jan 2024 and currently FDA-listed.

NDC 68382-0607-05
🏷️ FDA NDC (as labeled) 68382-607-05 billing pads the product segment with a zero
This package
Contains500-count Pack sizes3 compare ↓
Also priced by: Part D plans $3.80/unit — full pricing hub ↓
Product page 68382-0607-16 Also comes in: 90 tablets 68382-607-16 100 tablets 68382-607-77
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Gabapentin (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Oct 10, 2025 — Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity . (The Harvard Drug Group LLC) · FDA recall D-0031-2026
Class II · Oct 10, 2025 — Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity . (The Harvard Drug Group LLC) · FDA recall D-0030-2026
Class II · Jun 19, 2025 — Defective container; blister packaging inadequately sealed. (The Harvard Drug Group LLC) · FDA recall D-0507-2025
Class II · Jun 19, 2025 — Defective container; blister packaging inadequately sealed. (The Harvard Drug Group LLC) · FDA recall D-0508-2025
Class II · Mar 13, 2025 — CGMP Deviations (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0320-2025
Class III · Mar 4, 2025 — Cross Contamination (SUN PHARMACEUTICAL INDUSTRIES INC) · FDA recall D-0312-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 68382-607-05
Product NDC 68382-607
11-digit billing NDC 68382060705
RxCUI 1806380, 1806382, 2634743, 2634747, 2634751
UNII 6CW7F3G59X
UPC 0368382607164
Application # ANDA203934
SPL Set ID 3cfd04ab-e421-441f-a10e-e4dd1412974d
Physiologic effect Decreased Central Nervous System Disorganized Electrical Activity
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-01-25
Route ORAL
Dosage form TABLET
Substance GABAPENTIN
TE code (Orange Book) AB2 · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 62540030000330
GCN Seq No 067686
GCN 30296
HICL code 008831
Ingredient (HICL) Gabapentin
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H0
Therapeutic class — intermediate (HIC2) Act On Non-Autonomic Nervous System
HIC3 code H0D
Therapeutic class — specific (HIC3) Postherpetic Neuralgia Agents
AHFS code 28:08.92.00
AHFS class Analgesics And Antipyretics, Misc.
FDB label name GABAPENTIN ER 600 MG TABLET
FDB brand name Gabapentin Er
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 067686
  • GCN: 30296
  • GPI-14 (Medi-Span): 62540030000330
  • HICL (First Databank): 008831
  • AHFS class code: 28:08.92.00
  • RxCUI (RxNorm): 1806380
Why two NDCs? The FDA registers this code as 68382-607-05 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 68382-0607-05. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Gabapentinoids class.

Drug family (ATC) Gabapentinoids
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name GABAPENTIN ER 600 MG TABLET Ingredient Gabapentin
📗 Our plain-language guide HelloPharmacist
  • It's used for nerve pain after shingles (postherpetic neuralgia). Many gabapentin products are also used as add-on treatment for partial seizures in epilepsy. Horizant is also used...
  • Dizziness and sleepiness are the most common side effects. Don't drive or use heavy machinery until you know how it affects you, because you may not judge your own impairment well.
  • Talk to your prescriber first. Stopping seizure medicines suddenly can increase seizures. Gralise should be changed or stopped gradually over at least a week.
  • Tell me about any opioid or sedating medicine, because together they can slow breathing dangerously. If you use an antacid like Maalox, take gabapentin at least 2 hours after it.
📖 Read our full Gabapentin guide →
1
Nutrient depletion considerations

Gabapentin may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Gabapentin nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $3.80 $1,901.00 / 500 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
68382-0607-05 You're viewing this 500 TABLET in 1 BOTTLE — — 2024-01-25 — Active
68382-0607-16 68382-607-16 Main listing 90 TABLET in 1 BOTTLE $1.03 / ea $92.25 2024-01-25 — Active
68382-0607-77 68382-607-77 10 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK — — 2024-01-25 — Active

This pack shows little to no recent Medicaid volume — the 90 tablets pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in this package?
This is a 500-count package — 500 tablet in 1 bottle.
How does this package differ from NDC 68382-0607-16?
Both are gabapentin 600 mg Tablet — the drug itself is identical. This page's package is the 500-count one, while NDC 68382-0607-16 is the 90 tablets package.
What NDC number is used to bill for this package of gabapentin 600 mg Tablet?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Gabapentin 600 mg 71093-0111-04 ACI 100 tablets $0.064 AB1 Discontinued —
Gabapentin 600 mg 76282-0405-01 Exelan 100 tablets $0.064 — Availability likely —
Gabapentin 600 mg 82009-0071-05 QUALLENT 500 tablets $0.064 AB1 Availability likely —
Gabapentin 600 mg 16714-0330-01 NorthStar 100 tablets $0.064 AB1 Availability likely —
Gabapentin 600 mg 68462-0126-01 Glenmark 100 tablets $0.064 AB1 Availability likely —
Gabapentin 600 mg 16571-0226-01 Rising 100 tablets $0.064 AB1 Availability likely —
Gabapentin 600 mg 65862-0523-01 Aurobindo 100 tablets $0.064 AB1 Availability likely —
Gabapentin 600 mg 31722-0166-01 Camber 100 tablets $0.064 AB1 Availability likely —
Gabapentin 600 mg 68382-0204-01 Zydus 100 tablets $0.064 AB1 Availability likely —
Gabapentin 600 mg 69367-0346-05 Westminster 500 tablets $0.064 AB1 Availability likely —
Gabapentin 600 mg 00904-6823-61 Major 1 tablet $0.064 AB1 Availability likely —
Gabapentin 600 mg 60687-0507-01 American 1 tablet $0.064 AB1 Availability likely —
Gabapentin 600 mg 83301-0001-01 Mullan 100 tablets $0.064 AB1 Availability likely —
Gabapentin 600 mg 50228-0177-01 ScieGen 100 tablets $0.064 AB1 Availability likely —
Gabapentin 600 mg 68001-0411-00 BluePoint 100 tablets $0.064 AB1 Availability likely —
Gabapentin 600 mg 68094-0589-50 Precision 100 tablets $0.064 AB1 Availability likely —
Gabapentin 600 mg 67877-0428-01 Ascend 100 tablets $0.064 AB1 Availability likely —
Gabapentin 600 mg 50268-0325-15 AvPAK 1 tablet $0.064 AB1 Availability likely —
Gabapentin 600 mg 70010-0227-01 Granules 100 tablets $0.064 AB1 Availability likely —
Gabapentin 600 mg 64380-0727-01 Strides 100 tablets $0.064 AB1 Availability likely —
Gabapentin 600 mg 76282-0706-05 Exelan 500 tablets $0.064 AB1 Availability likely —
Gabapentin 600 mg 68094-0069-61 Precision 10 tablets $0.064 AB1 Availability likely —
gabapentin 600 mg 62756-0202-01 Sun 100 tablets $0.068 — FDA listed —
Gabapentin 600 mg 51224-0021-50 TAGI 100 tablets $0.098 AB1 Discontinued —
Gabapentin 600 mg 31722-0092-90 Camber 90 tablets $1.025 AB2 Availability likely —
Gabapentin 600 mg 42806-0657-09 Epic 90 tablets $1.025 AB2 Availability likely —
Gralise 600 mg 52427-0806-90 Almatica 90 tablets $10.153 AB2 Availability likely —
Neurontin 600 mg 00071-0513-24 Parke-Davis 100 tablets $14.084 AB1 Discontinued —
Neurontin 600 mg 58151-0284-01 Viatris 100 tablets $14.119 AB1 Availability likely —
gabapentin 600 mg 50228-0524-05 ScieGen 500 tablets — AB2 FDA listed —
gabapentin 600 mgthis 68382-0607-05 Zydus 500 tablets — AB2 FDA listed —
gabapentin 600 mg 70771-1862-04 Zydus 100 tablets — AB2 FDA listed —
Gabapentin 600 mg 63187-0057-00 Proficient 100 tablets — AB1 FDA listed —
Gabapentin 600 mg 63187-0785-00 Proficient 100 tablets — — FDA listed —
Gabapentin 600 mg 71205-0457-30 Proficient 30 tablets — AB1 FDA listed —
Gabapentin 600 mg 71205-0533-30 Proficient 30 tablets — AB1 FDA listed —
Gabapentin 600 mg 71205-0931-00 Proficient 100 tablets — AB1 FDA listed —
Gabapentin 600 mg 71610-0044-30 Aphena 30 tablets — AB1 FDA listed —
gabapentin 600 mg 71610-0069-45 Aphena 45 tablets — — FDA listed —
Gabapentin 600 mg 71610-0621-15 Aphena 15 tablets — AB1 FDA listed —
Gabapentin 600 mg 76420-0235-12 Asclemed 120 tablets — AB1 FDA listed —
Gabapentin 600 mg 60760-0987-90 St. 90 tablets — AB1 FDA listed —
Gabapentin 600 mg 69097-0812-02 Cipla 30 tablets — — FDA listed —
Gabapentin 600 mg 71610-0767-30 Aphena 30 tablets — AB1 FDA listed —
Gabapentin 600 mg 72162-2141-01 Bryant 100 tablets — AB1 FDA listed —
Gabapentin 600 mg 82804-0015-30 Proficient 30 tablets — AB1 FDA listed —
Gabapentin 600 mg 82804-0193-30 Proficient 30 tablets — AB1 FDA listed —
Gabapentin 600 mg 42385-0979-01 Laurus 100 tablets — AB1 FDA listed —
Gabapentin 600 mg 50090-6854-00 A-S 90 tablets — AB1 FDA listed —
Gabapentin 600 mg 55154-8189-00 Cardinal 1 tablet — AB1 FDA listed —
Gabapentin 600 mg 63629-7307-01 Bryant 90 tablets — AB1 FDA listed —
Gabapentin 600 mg 70518-2098-00 REMEDYREPACK 30 tablets — AB1 Discontinued —
Gabapentin 600 mg 71335-1200-00 Bryant 28 tablets — AB1 FDA listed —
Gabapentin 600 mg 71610-0777-30 Aphena 30 tablets — AB1 FDA listed —
Gabapentin 600 mg 76420-0836-01 Asclemed 100 tablets — AB1 FDA listed —
Gabapentin 600 mg 82619-0145-01 Creekwood 100 tablets — AB1 FDA listed —
Gabapentin 600 mg 58118-0166-08 Clinical 30 tablets — AB1 FDA listed —
Gabapentin 600 mg 63629-8492-01 Bryant 100 tablets — AB1 FDA listed —
Gabapentin 600 mg 67046-1535-03 Coupler 30 tablets — AB1 FDA listed —
Gabapentin 600 mg 71335-2281-01 Bryant 500 tablets — AB1 FDA listed —
Gabapentin 600 mg 71335-2719-01 Bryant 90 tablets — AB1 FDA listed —
Gabapentin 600 mg 50090-7715-00 A-S 90 tablets — AB1 FDA listed —
Gabapentin 600 mg 68788-8476-01 Preferred 100 tablets — AB1 FDA listed —
Gabapentin 600 mg 68788-8488-01 Preferred 100 tablets — AB1 FDA listed —
Gabapentin 600 mg 70518-2842-00 REMEDYREPACK 28 tablets — AB1 Discontinued —
Gabapentin 600 mg 72888-0131-00 Advagen 1000 tablets — AB1 FDA listed —
Gabapentin 600 mg 80425-0097-01 Advanced 30 tablets — AB1 FDA listed —
Gabapentin 600 mg 83008-0063-60 Quality 60 tablets — AB1 Discontinued —
Gabapentin 600 mg 50090-6855-00 A-S 90 tablets — AB1 FDA listed —
Gabapentin 600 mg 55289-0959-30 PD-Rx 30 tablets — AB1 FDA listed —
Gabapentin 600 mg 65841-0705-01 Zydus 100 tablets — AB1 FDA listed —
Gabapentin 600 mg 68071-3445-03 NuCare 30 tablets — AB1 FDA listed —
Gabapentin 600 mg 70518-2616-03 REMEDYREPACK 30 tablets — AB1 Discontinued —
Gabapentin 600 mg 71335-3060-00 Bryant 28 tablets — AB1 FDA listed —
Gabapentin 600 mg 72162-1530-01 Bryant 100 tablets — AB1 FDA listed —
Gabapentin 600 mg 72189-0471-30 Direct_Rx 30 tablets — AB1 FDA listed —
Gabapentin 600 mg 72865-0255-05 XLCare 500 tablets — AB1 FDA listed —
Gabapentin 600 mg 70518-4532-00 REMEDYREPACK 1 tablet — AB1 FDA listed —
Gabapentin 600 mg 72789-0127-30 PD-Rx 30 tablets — AB1 FDA listed —
Gabapentin 600 mg 77771-0177-05 Radha 500 tablets — AB1 FDA listed —
Gabapentin 600 mg 80425-0201-01 Advanced 30 tablets — AB1 FDA listed —
Gabapentin 600 mg 55154-3357-00 Cardinal 1 tablet — AB1 FDA listed —
Gabapentin 600 mg 68071-3783-09 NuCare 90 tablets — AB1 FDA listed —
Gabapentin 600 mg 71335-3143-01 Bryant 90 tablets — AB1 FDA listed —
Gabapentin 600 mg 82804-0210-90 Proficient 90 tablets — AB1 FDA listed —
Gabapentin 600 mg 60760-0066-60 St. 60 tablets — AB1 Discontinued —
Gabapentin 600 mg 71335-1132-00 Bryant 28 tablets — AB1 Discontinued —
Gabapentin 600 mg 71335-1287-00 Bryant 28 tablets — AB1 FDA listed —
Gabapentin 600 mg 72189-0313-60 Directrx 60 tablets — AB1 FDA listed —
Gabapentin 600 mg 50090-7268-00 A-S 90 tablets — AB1 FDA listed —
Gabapentin 600 mg 63629-3063-00 Bryant 45 tablets — AB1 FDA listed —
Gabapentin 600 mg 63629-8491-01 Bryant 500 tablets — AB1 FDA listed —
Gabapentin 600 mg 70518-2356-00 REMEDYREPACK 30 tablets — AB1 FDA listed —
Gabapentin 600 mg 71335-2048-01 Bryant 90 tablets — AB1 FDA listed —
Gabapentin 600 mg 71335-2701-00 Bryant 28 tablets — AB1 FDA listed —
Gabapentin 600 mg 50090-7269-00 A-S 90 tablets — AB1 FDA listed —
Gabapentin 600 mg 50090-7714-00 A-S 90 tablets — AB1 FDA listed —
Gabapentin 600 mg 60760-0743-90 St. 90 tablets — AB1 FDA listed —
Gabapentin 600 mg 71335-1026-01 Bryant 90 tablets — AB1 Discontinued —
Gabapentin 600 mg 87441-0036-01 Unit 30 tablets — AB1 FDA listed —
Gabapentin 600 mg 85534-0009-00 HAWAII 30 tablets — AB1 FDA listed —
Gabapentin 600 mg 67046-1086-03 Coupler 30 tablets — AB1 FDA listed —
Gabapentin 600 mg 67046-1233-03 Coupler 30 tablets — AB1 FDA listed —
Gabapentin 600 mg 85509-1166-03 PHOENIX 30 tablets — AB1 FDA listed —
Gabapentin 600 mg 58118-2126-08 Clinical 30 tablets — AB1 FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2024
On the market since
Jan 2024
📍
2026
Currently FDA-listed
2 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color White
ShapeOval
Imprint357
Size2 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerZydus Pharmaceuticals USA Inc.
Application holderZYDUS PHARMACEUTICALS USA INC
FDA applicationANDA203934 (ANDA)
Labeler code68382
First marketedJan 2024
Product typeHuman Prescription Drug
Portfolio454 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide 🍼 Nursing Mothers 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🔒 Drug Abuse and Dependence 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 73 words ▾

1 INDICATIONS AND USAGE Gabapentin tablet is indicated for the management of postherpetic neuralgia. Once-daily gabapentin tablets are not substitutable with other gabapentin products because of differing pharmacokinetic profiles that affect the frequency of administration. Gabapentin tablet is indicated for the management of Postherpetic Neuralgia (PHN).

Important Limitation Once-daily gabapentin tablets are not substitutable with other gabapentin products because of differing pharmacokinetic profiles that affect the frequency of administration (see Warnings and Precautions).

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION Gabapentin tablet should be titrated to an 1,800 mg dose taken orally, once-daily with the evening meal. Gabapentin tablets should be swallowed whole. Do not crush, split or chew the tablets.

( 2.1 ) If gabapentin dose is reduced, discontinued, or substituted with an alternative medication, this should be done gradually over a minimum of 1 week or longer (at the discretion of the prescriber). ( 2.1 ) Renal impairment: Dose should be adjusted in patients with reduced renal function. Gabapentin tablet should not be used in patients with CrCl less than 30 or in patients on hemodialysis.

( 2.2 )

2.1Postherpetic Neuralgia Do not use Once-daily gabapentin tablets as a substitute for other gabapentin products. Titrate gabapentin tablet to an 1,800 mg dose taken orally once daily with the evening meal. Gabapentin tablets should be swallowed whole.

Do not split, crush, or chew the tablets. If gabapentin dosing is reduced, discontinued, or substituted with an alternative medication, this should be done gradually over a minimum of one week or longer (at the discretion of the prescriber). In adults with postherpetic neuralgia, gabapentin therapy should be initiated and titrated as follows: Table 1 Gabapentin Recommended Titration Schedule Day 1 Day 2 Days 3 to 6 Days 7 to 10 Days 11 to 14 Day 15 Daily Dose 300 mg 600 mg 900 mg 1,200 mg 1,500 mg 1,800 mg

2.2Patients with Renal Impairment In patients with stable renal function, creatinine clearance (C Cr ) can be reasonably well estimated using the equation of Cockcroft and Gault: For females C Cr =(0.85)(140-age)(weight)/[(72)(S Cr )] For males C Cr =(140-age)(weight)/[(72)(S Cr )] where age is in years, weight is in kilograms and S Cr is serum creatinine in mg/dL. The dose of gabapentin should be adjusted in patients with reduced renal function, according to Table 2. Patients with reduced renal function must initiate gabapentin at a daily dose of 300 mg.

Gabapentin should be titrated following the schedule outlined in Table 1. Daily dosing in patients with reduced renal function must be individualized based on tolerability and desired clinical benefit. Table 2 Gabapentin Tablet Dosage Based on Renal Function Once-daily dosing Creatinine Clearance (mL/min) Gabapentin Tablet Dose (once daily with evening meal) ≥ 60 1,800 mg 30 to 60 600 mg to 1,800 mg < 30 Gabapentin tablet should not be administered patients receiving hemodialysis Gabapentin tablet should not be administered

💊 Dosage Forms and Strengths 144 words ▾

3 DOSAGE FORMS AND STRENGTHS Gabapentin Tablets, 300 mg are white to off-white, oval, film-coated tablets debossed with "608" on one side and plain on theother side. Gabapentin Tablets, 450 mg are white to off-white, oval shaped, beveled edge, film coated tablets debossed with "355" on oneside and plain on the other side. Gabapentin Tablets, 600 mg are white to off-white, oval, beveled edge film coated tablets debossed with "607" on one side andplain on the other side.

Gabapentin Tablets, 750 mg are white to off-white, oval shaped, beveled edge, film coated tablets debossed with "356" on oneside and plain on the other side. Gabapentin Tablets, 900 mg are white to off-white, oval shaped, beveled edge, film coated tablets debossed with "357" on oneside and plain on the other side. Tablets: 300 mg, 450 mg, 600 mg,750 mg and 900 mg ( 3 )

⛔ Contraindications 36 words ▾

4 CONTRAINDICATIONS Gabapentin tablet is contraindicated in patients with demonstrated hypersensitivity to the drug or its ingredients. Gabapentin tablet is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Once-daily gabapentin tablets are not substitutable with other gabapentin products because of differing pharmacokinetic profiles that affect the frequency of administration. The safety and effectiveness of gabapentin in patients with epilepsy has not been studied. Once-daily gabapentin tablets are not substitutable with other gabapentin products Antiepileptic drugs, including gabapentin, the active ingredient in gabapentin tablet, increase the risk of suicidal thoughts or behavior ( 5.1 ) Abrupt or rapid discontinuation may increase the risk for seizures.

Withdrawal symptoms or suicidal behavior and ideation have been observed after discontinuation. Taper gabapentin tablet gradually over a minimum of 1 week. ( 5.2 ) Respiratory depression may occur with gabapentin when used with concomitant CNS depressants or in the setting of underlying respiratory impairment.

Monitor patients and adjust dosage as appropriate. ( 5.3 )

5.1Suicidal Behavior and Ideation Antiepileptic drugs (AEDs), including gabapentin, the active ingredient in gabapentin tablet, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Suicidal behavior and ideation have also been reported in patients after discontinuation of gabapentin [see Warnings and Precautions ( 5.3 )]. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.

Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) of 11 different AEDs showed that patients randomized to one of the AEDs had approximately twice the risk (adjusted Relative Risk 1.8, 95% CI:1.2, 2.7) of suicidal thinking or behavior compared to patients randomized to placebo. In these trials, which had a median treatment duration of 12 weeks, the estimated incidence rate of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal thinking or behavior for every 530 patients treated.

There were four suicides in drug-treated patients in the trials and none in placebo-treated patients, but the number is too small to allow any conclusion about drug effect on suicide. The increased risk of suicidal thoughts or behavior with AEDs was observed as early as one week after starting drug treatment with AEDs and persisted for the duration of treatment assessed. Because most trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or behavior beyond 24 weeks could not be assessed.

The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed. The finding of increased risk with AEDs of varying mechanisms of action and across a range of indications suggests that the risk applies to all AEDs used for any indication. The risk did not vary substantially by age (5 to 100 years) in the clinical trials analyzed.

Table 3 shows absolute and relative risk by indication for all evaluated AEDs. Table 3 Risk by Indication for Antiepileptic Drugs (including gabapentin, the active ingredient in gabapentin tablet) in the Pooled Analysis Indication Placebo Patients with Events Per 1,000 Patients Drug Patients with Events Per 1,000 Patients Relative Risk: Incidence of Events in Drug Patients/Incidence in Placebo Patients Risk Difference: Additional Drug Patients with Events Per 1,000 Patients Epilepsy 1 3.4 3.5

2.4Psychiatric 5.7 8.5 1.5

2.9Other 1 1.8 1.9

0.9Total 2.4 4.3 1.8

1.9The relative risk for suicidal thoughts or behavior was higher in clinical trials for epilepsy than in clinical trials for psychiatric or other conditions, but the absolute risk differences were similar for the epilepsy and psychiatric indications. Anyone considering prescribing gabapentin must balance the risk of suicidal thoughts o… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are described elsewhere in the labeling: Suicidal Behavior and Ideation [see Warnings and Precautions ( 5.1 )] Increased Risk of Adverse Reactions with Abrupt or Rapid Discontinuation [see Warnings and Precautions ( 5.2 )] Respiratory Depression [see Warnings and Precautions ( 5.3 )] Tumorigenic Potential [see Warnings and Precautions ( 5.4 )] Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity [see Warnings and Precautions ( 5.5 )] Laboratory Tests [see Warnings and Precautions ( 5.6 )] The most common adverse reaction (greater than or equal to 5% and twice placebo) is dizziness.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) Inc. at 1- 877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. A total of 359 patients with neuropathic pain associated with postherpetic neuralgia have received gabapentin at doses up to 1,800 mg daily during placebo-controlled clinical studies. In clinical trials in patients with postherpetic neuralgia, 9.7% of the 359 patients treated with gabapentin and 6.9% of 364 patients treated with placebo discontinued prematurely due to adverse reactions.

In the gabapentin treatment group, the most common reason for discontinuation due to adverse reactions was dizziness. Of gabapentin-treated patients who experienced adverse reactions in clinical studies, the majority of those adverse reactions were either "mild" or "moderate". Table 4 lists all adverse reactions, regardless of causality, occurring in at least 1% of patients with neuropathic pain associated with postherpetic neuralgia in the gabapentin group for which the incidence was greater than in the placebo group.

Table 4 Treatment-Emergent Adverse Reaction Incidence in Controlled Trials in Neuropathic Pain Associated with Postherpetic Neuralgia (Events in at Least 1% of all Gabapentin-Treated Patients and More Frequent Than in the Placebo Group) Body System – Preferred Term Gabapentin N = 359 % Placebo N = 364 % Ear and Labyrinth Disorders Vertigo 1.4

0.5Gastrointestinal Disorders Diarrhea Dry mouth Constipation Dyspepsia 3.3 2.8 1.4 1.4 2.7 1.4 0.3

0.8General Disorders Peripheral edema Pain 3.9 1.1 0.3

0.5Infections and Infestations Nasopharyngitis Urinary tract infection 2.5 1.7 2.2

0.5Investigations Weight increased 1.9

0.5Musculoskeletal and Connective Tissue Disorders Pain in extremity Back pain 1.9 1.7 0.5

1.1Nervous System Disorders Dizziness Somnolence Headache Lethargy 10.9 4.5 4.2 1.1 2.2 2.7 4.1

0.3In addition to the adverse reactions reported in Table 4 above, the following adverse reactions with an uncertain relationship to gabapentin were reported during the clinical development for the treatment of postherpetic neuralgia. Events in more than 1% of patients but equally or more frequently in the gabapentin-treated patients than in the placebo group included blood pressure increase, confusional state, gastroenteritis viral, herpes zoster, hypertension, joint swelling, memory impairment, nausea, pneumonia, pyrexia, rash, seasonal allergy, and upper respiratory infection.

6.2Postmarketing and Other Experience with other Formulations of Gabapentin In addition to the adverse experiences reported during clinical testing of gabapentin, the following adverse experiences have been reported in patients receiving other formulations of marketed gabapentin. These adverse experiences have not been listed above and data are insufficient to support an estimate of their incidence or to establish causation. The listing is alphabetized: angioedema, blood glucose fluctuation, breast enlargement, bullous pemphigoid, elevated creat… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~3 min read ▾

7 DRUG INTERACTIONS In vitro studies were conducted to investigate the potential of gabapentin to inhibit the major cytochrome P450 enzymes (CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1, and CYP3A4) that mediate drug and xenobiotic metabolism using isoform selective marker substrates and human liver microsomal preparations. Only at the highest concentration tested (171 mcg/mL; 1mM) was a slight degree of inhibition (14% to 30%) of isoform CYP2A6 observed. No inhibition of any of the other isoforms tested was observed at gabapentin concentrations up to 171 mcg/mL (approximately 15 times the C max at 3,600 mg/day).

Gabapentin is not appreciably metabolized nor does it interfere with the metabolism of commonly coadministered antiepileptic drugs. The drug interaction data described in this section were obtained from studies involving healthy adults and adult patients with epilepsy. An increase in gabapentin AUC values have been reported when administered with hydrocodone.

( 7.6 ) An increase in gabapentin AUC values have been reported when administered with morphine. ( 7.7 ) An antacid containing aluminum hydroxide and magnesium hydroxide reduced the bioavailability of gabapentin immediate release by about approximately 20%, but by only 5% when gabapentin was taken 2 hours after antacids. It is recommended that gabapentin be taken at least 2 hours following antacid administration.

( 7.10 )

7.1Phenytoin In a single (400 mg) and multiple dose (400 mg three times daily) study of gabapentin immediate release in epileptic patients (N=8) maintained on phenytoin monotherapy for at least 2 months, gabapentin had no effect on the steady-state trough plasma concentrations of phenytoin and phenytoin had no effect on gabapentin pharmacokinetics.

7.2Carbamazepine Steady-state trough plasma carbamazepine and carbamazepine 10, 11 epoxide concentrations were not affected by concomitant gabapentin immediate release (400 mg three times daily; N=12) administration. Likewise, gabapentin pharmacokinetics were unaltered by carbamazepine administration.

7.3Valproic Acid The mean steady-state trough serum valproic acid concentrations prior to and during concomitant gabapentin immediate release administration (400 mg three times daily; N=17) were not different and neither were gabapentin pharmacokinetic parameters affected by valproic acid.

7.4Phenobarbital Estimates of steady-state pharmacokinetic parameters for phenobarbital or gabapentin immediate release (300 mg three times daily; N=12) are identical whether the drugs are administered alone or together.

7.5Naproxen Coadministration of single doses of naproxen (250 mg) and gabapentin immediate release (125 mg) to 18 volunteers increased gabapentin absorption by 12% to 15%. Gabapentin immediate release had no effect on naproxen pharmacokinetics. The doses are lower than the therapeutic doses for both drugs. The effect of coadministration of these drugs at therapeutic doses is not known.

7.6Hydrocodone Coadministration of gabapentin immediate release (125 mg and 500 mg) and hydrocodone (10 mg) reduced hydrocodone C max by 3% and 21%, respectively, and AUC by 4% and 22%, respectively. The mechanism of this interaction is unknown. Gabapentin AUC values were increased by 14%; the magnitude of the interaction at other doses is not known.

7.7Morphine When a single dose (60 mg) of controlled-release morphine capsule was administered 2 hours prior to a single dose (600 mg) of gabapentin immediate release in 12 volunteers, mean gabapentin AUC values increased by 44% compared to gabapentin immediate release administered without morphine. The pharmacokinetics of morphine were not affected by administration of gabapentin immediate release 2 hours after morphine. The magnitude of this interaction at other doses is not known.

7.8Cimetidine Cimetidine 300 mg decreased the apparent oral clearance of gabapentin by 14% and creatinine clearance by 10%. The effect of gabapentin immediate release on cimetidine wa… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Elderly: Reductions in gabapentin dose should be made in patients with age-related compromised renal function. ( 8.5 ) Renal impairment: Dosage adjustment is necessary for patients with impaired renal function. ( 8.7 )

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to gabapentin, including gabapentin, during pregnancy. Encourage women who are taking gabapentin during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling the toll free number 1-888-233-2334 or visiting https://www.aedpregnancyregistry.org/. Risk Summary Available data from published prospective and retrospective cohort studies, and case reports over decades of use with gabapentin during pregnancy have not identified a drug-associated risk of major birth defects.

The available data are insufficient to evaluate a drug-associated risk of miscarriage and other maternal or fetal outcomes. In nonclinical studies in mice, rats, and rabbits, gabapentin was developmentally toxic (increased fetal skeletal and visceral abnormalities, and increased embryofetal mortality) when administered to pregnant animals at doses similar to those used clinically (see Data) . Postmarketing data suggest that extended gabapentin use with opioids close to delivery may increase the risk of neonatal withdrawal versus opioids alone [see Clinical Considerations] .

Although there is at least one report of neonatal withdrawal syndrome in an infant exposed to gabapentin alone during pregnancy, there are no comparative epidemiologic studies evaluating this association. Therefore, it is not known whether exposure to gabapentin alone late in pregnancy may cause withdrawal signs and symptoms. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Neonatal withdrawal syndrome has been reported in newborns exposed to gabapentin in utero for an extended period of time when also exposed to opioids close to delivery.

Neonatal withdrawal signs and symptoms reported have included tachypnea, vomiting, diarrhea, hypertonia, irritability, sneezing, poor feeding, hyperactivity, abnormal sleep pattern and tremor. Reported signs and symptoms that may also be related to withdrawal include tongue thrusting, wandering eye movements while awake, back arching, and continuous extremity movements. Observe neonates exposed to gabapentin tablets and opioids for signs and symptoms of neonatal withdrawal and manage accordingly.

Data Animal Data When pregnant mice received oral doses of gabapentin (1,000 or 3,000 mg/kg/day, approximately 3 to 8 times the maximum recommended dose of 1,800 mg on a mg/m 2 basis) during the period of organogenesis, embryofetal toxicity (increased incidences of skeletal variations) was observed. The no effect level was 500 mg/kg/day, representing approximately the maximum recommended human dose [MRHD] on a mg/m 2 basis. When rats were dosed prior to and during mating, and throughout gestation, pups from all dose groups (500, 1,000 and 2,000 mg/kg/day) were affected.

These doses are equivalent to approximately 3 to 11 times the MRHD on a mg/m 2 basis. There was an increased incidence of hydroureter and/or hydronephrosis in rats in a study of fertility and general reproductive performance at 2,000 mg/kg/day with no effect at 1,000 mg/kg/day, in a teratology study at 1,500 mg/kg/day with no effect at 300 mg/kg/day, and in a perinatal and postnatal study at all doses studied (500, 1,000 and 2,000 mg/kg/day). The doses at which the effects occurred are approximately 3 to… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to gabapentin, including gabapentin, during pregnancy. Encourage women who are taking gabapentin during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling the toll free number 1-888-233-2334 or visiting https://www.aedpregnancyregistry.org/. Risk Summary Available data from published prospective and retrospective cohort studies, and case reports over decades of use with gabapentin during pregnancy have not identified a drug-associated risk of major birth defects.

The available data are insufficient to evaluate a drug-associated risk of miscarriage and other maternal or fetal outcomes. In nonclinical studies in mice, rats, and rabbits, gabapentin was developmentally toxic (increased fetal skeletal and visceral abnormalities, and increased embryofetal mortality) when administered to pregnant animals at doses similar to those used clinically (see Data) . Postmarketing data suggest that extended gabapentin use with opioids close to delivery may increase the risk of neonatal withdrawal versus opioids alone [see Clinical Considerations] .

Although there is at least one report of neonatal withdrawal syndrome in an infant exposed to gabapentin alone during pregnancy, there are no comparative epidemiologic studies evaluating this association. Therefore, it is not known whether exposure to gabapentin alone late in pregnancy may cause withdrawal signs and symptoms. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Neonatal withdrawal syndrome has been reported in newborns exposed to gabapentin in utero for an extended period of time when also exposed to opioids close to delivery.

Neonatal withdrawal signs and symptoms reported have included tachypnea, vomiting, diarrhea, hypertonia, irritability, sneezing, poor feeding, hyperactivity, abnormal sleep pattern and tremor. Reported signs and symptoms that may also be related to withdrawal include tongue thrusting, wandering eye movements while awake, back arching, and continuous extremity movements. Observe neonates exposed to gabapentin tablets and opioids for signs and symptoms of neonatal withdrawal and manage accordingly.

Data Animal Data When pregnant mice received oral doses of gabapentin (1,000 or 3,000 mg/kg/day, approximately 3 to 8 times the maximum recommended dose of 1,800 mg on a mg/m 2 basis) during the period of organogenesis, embryofetal toxicity (increased incidences of skeletal variations) was observed. The no effect level was 500 mg/kg/day, representing approximately the maximum recommended human dose [MRHD] on a mg/m 2 basis. When rats were dosed prior to and during mating, and throughout gestation, pups from all dose groups (500, 1,000 and 2,000 mg/kg/day) were affected.

These doses are equivalent to approximately 3 to 11 times the MRHD on a mg/m 2 basis. There was an increased incidence of hydroureter and/or hydronephrosis in rats in a study of fertility and general reproductive performance at 2,000 mg/kg/day with no effect at 1,000 mg/kg/day, in a teratology study at 1,500 mg/kg/day with no effect at 300 mg/kg/day, and in a perinatal and postnatal study at all doses studied (500, 1,000 and 2,000 mg/kg/day). The doses at which the effects occurred are approximately 3 to 11 times the maximum recommended dose of 1,800 mg on a mg/m 2 basis; the no-effect doses were approximately 5 times (Fertility and General Reproductive Performance study) and approximately equal to (Teratogenicity study) the MRHD on a mg/m 2 basis.… [Excerpted — this section continues on DailyMed.]

🧒 Pediatric Use 27 words ▾

8.4Pediatric Use The safety and effectiveness of gabapentin in the management of postherpetic neuralgia in patients less than 18 years of age has not been studied.

🧓 Geriatric Use 88 words ▾

8.5Geriatric Use The total number of patients treated with gabapentin in controlled clinical trials in patients with postherpetic neuralgia was 359, of which 63% were 65 years of age or older. The types and incidence of adverse events were similar across age groups except for peripheral edema, which tended to increase in incidence with age. Gabapentin is known to be substantially excreted by the kidney.

Reductions in gabapentin dose should be made in patients with age-related compromised renal function [see Dosage and Administration ( 2.2 )] .

🆘 Overdosage 90 words ▾

10 OVERDOSAGE Signs of acute toxicity in animals included ataxia, labored breathing, ptosis, sedation, hypoactivity, or excitation. Acute oral overdoses of gabapentin have been reported. Symptoms include double-vision, tremor, slurred speech, drowsiness, altered mental status, dizziness, lethargy, and diarrhea.

Fatal respiratory depression has been reported with gabapentin overdose, alone and in combination with other central nervous system (CNS) depressants. Gabapentin can be removed by hemodialysis. Hemodialysis has been performed in overdose cases reported, and it may be indicated by the patient's clinical state or in patients with significant renal impairment.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The mechanism of action by which gabapentin exerts its analgesic action is unknown but in animal models of analgesia, gabapentin prevents allodynia (pain-related behavior in response to a normally innocuous stimulus) and hyperalgesia (exaggerated response to painful stimuli). Gabapentin prevents pain-related responses in several models of neuropathic pain in rats and mice (e.g., spinal nerve ligation models, spinal cord injury model, acute herpes zoster infection model). Gabapentin also decreases pain-related responses after peripheral inflammation (carrageenan footpad test, late phase of formulin test), but does not alter immediate pain-related behaviors (rat tail flick test, formalin footpad acute phase).

The relevance of these models to human pain is not known. Gabapentin is structurally related to the neurotransmitter GABA (gamma-aminobutyric acid), but it does not modify GABA A or GABA B radioligand binding, it is not converted metabolically into GABA or a GABA agonist, and it is not an inhibitor of GABA uptake or degradation. In radioligand binding assays at concentrations up to 100 μM, gabapentin did not exhibit affinity for a number of other receptor sites, including benzodiazepine, glutamate, N-methyl-D-aspartate (NMDA), quisqualate, kainate, strychnine-insensitive or strychnine-sensitive glycine; alpha 1, alpha 2, or beta adrenergic; adenosine A1 or A2; cholinergic, muscarinic, or nicotinic; dopamine D1 or D2; histamine H1; serotonin S1 or S2; opiate mu, delta, or kappa; cannabinoid 1; voltage-sensitive calcium channel sites labeled with nitrendipine or diltiazem; or at voltage-sensitive sodium channel sites labeled with batrachotoxinin A20-alpha-benzoate.

Gabapentin did not alter the cellular uptake of dopamine, noradrenaline, or serotonin. In vitro studies with radiolabeled gabapentin have revealed a gabapentin binding site in areas of rat brain including neocortex and hippocampus. A high-affinity binding protein in animal brain tissue has been identified as an auxiliary subunit of voltage-activated calcium channels.

However, functional correlates of gabapentin binding, if any, remain to be elucidated. It is hypothesized that gabapentin antagonizes thrombospondin binding to α2δ-1 as a receptor involved in excitatory synapse formation and suggested that gabapentin may function therapeutically by blocking new synapse formation.

12.2Pharmacodynamics No pharmacodynamic studies have been conducted with gabapentin.

12.3Pharmacokinetics Absorption Gabapentin is absorbed from the proximal small bowel by a saturable L-amino transport system. Gabapentin bioavailability is not dose proportional; as the dose is increased, bioavailability decreases. When gabapentin (1,800 mg once daily) and gabapentin immediate release (600 mg three times a day) were administered with high fat meals (50% of calories from fat), gabapentin has a higher C max and lower AUC at steady state compared to gabapentin immediate release (Table 5).

Time to reach maximum plasma concentration (T max ) for gabapentin is 8 hours, which is about 4 hours to 6 hours longer compared to gabapentin immediate release. Table 5 Mean ± SD Steady-State Pharmacokinetics for Gabapentin and Gabapentin Immediate Release in Healthy Subjects under high-fat high calorie fed state (Day 5, n = 21) $ T max is presented as median (range); * relative to most recent dose Pharmacokinetic Parameter (Mean ± SD) Gabapentin 1,800 mg QD (3 x 600 mg) Gabapentin Immediate Release 600 mg TID AUC0-24 (mcg hr/mL) 132.8 ± 34.7 141.3 ±

29.8C max (mcg/mL) 9.59 ± 2.33 8.54 ±

1.72C min (mcg/mL) 1.84 ± 0.65 2.6 ±

0.78T max (hr) $ 8 (3 to 12) 2 (1 to 5)* The single dose pharmacokinetic parameters of 900 mg strength under high fat-high calorie fed state and low fat-low calorie fed state are presented shown in Table 6. Mean ± SD Single-Dose Pharmacokinetic parameters for Gabapentin 900 mg strength in Healthy Subjects (n = 27) $ Tmax is presented as… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action ~2 min read ▾

12.1Mechanism of Action The mechanism of action by which gabapentin exerts its analgesic action is unknown but in animal models of analgesia, gabapentin prevents allodynia (pain-related behavior in response to a normally innocuous stimulus) and hyperalgesia (exaggerated response to painful stimuli). Gabapentin prevents pain-related responses in several models of neuropathic pain in rats and mice (e.g., spinal nerve ligation models, spinal cord injury model, acute herpes zoster infection model). Gabapentin also decreases pain-related responses after peripheral inflammation (carrageenan footpad test, late phase of formulin test), but does not alter immediate pain-related behaviors (rat tail flick test, formalin footpad acute phase).

The relevance of these models to human pain is not known. Gabapentin is structurally related to the neurotransmitter GABA (gamma-aminobutyric acid), but it does not modify GABA A or GABA B radioligand binding, it is not converted metabolically into GABA or a GABA agonist, and it is not an inhibitor of GABA uptake or degradation. In radioligand binding assays at concentrations up to 100 μM, gabapentin did not exhibit affinity for a number of other receptor sites, including benzodiazepine, glutamate, N-methyl-D-aspartate (NMDA), quisqualate, kainate, strychnine-insensitive or strychnine-sensitive glycine; alpha 1, alpha 2, or beta adrenergic; adenosine A1 or A2; cholinergic, muscarinic, or nicotinic; dopamine D1 or D2; histamine H1; serotonin S1 or S2; opiate mu, delta, or kappa; cannabinoid 1; voltage-sensitive calcium channel sites labeled with nitrendipine or diltiazem; or at voltage-sensitive sodium channel sites labeled with batrachotoxinin A20-alpha-benzoate.

Gabapentin did not alter the cellular uptake of dopamine, noradrenaline, or serotonin. In vitro studies with radiolabeled gabapentin have revealed a gabapentin binding site in areas of rat brain including neocortex and hippocampus. A high-affinity binding protein in animal brain tissue has been identified as an auxiliary subunit of voltage-activated calcium channels.

However, functional correlates of gabapentin binding, if any, remain to be elucidated. It is hypothesized that gabapentin antagonizes thrombospondin binding to α2δ-1 as a receptor involved in excitatory synapse formation and suggested that gabapentin may function therapeutically by blocking new synapse formation.

📦 How Supplied / Storage and Handling ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Gabapentin Tablets, 300 mg are white to off-white, oval, film-coated tablets debossed with "608" on one side and plain on the other side and are supplied as follows: NDC 68382-608-16 in bottle of 90 tablets with child-resistant closure NDC 68382-608-05 in bottle of 500 tablets NDC 68382-608-77 in unit-dose blister cartons of 100 (10 x 10) unit dose tablets Gabapentin Tablets, 450 mg are white to off-white, oval shaped, beveled edge, film coated tablets debossed with "355" on one side and plain on the other side and are supplied as follows: NDC 68382-355-14 in bottle of 60 tablets with child-resistant closure NDC 68382-355-01 in bottle of 100 tablets with child-resistant closure Gabapentin Tablets, 600 mg are white to off-white, oval, beveled edge film coated tablets debossed with "607" on one side and plain on the other side and are supplied as follows: NDC 68382-607-16 in bottle of 90 tablets with child-resistant closure NDC 68382-607-05 in bottle of 500 tablets NDC 68382-607-77 in unit-dose blister cartons of 100 (10 x 10) unit dose tablets Gabapentin Tablets, 750 mg are white to off-white, oval shaped, beveled edge, film coated tablets debossed with "356" on one side and plain on the other side and are supplied as follows: NDC 68382-356-14 in bottle of 60 tablets with child-resistant closure NDC 68382-356-01 in bottle of 100 tablets with child-resistant closure Gabapentin Tablets, 900 mg are white to off-white, oval shaped, beveled edge, film coated tablets debossed with "357" on one side and plain on the other side. and are supplied as follows: NDC 68382-357-14in bottle of 60 tablets with child-resistant closure NDC 68382-357-01in bottle of 100 tablets with child-resistant closure Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15ºC to 30ºC (59ºF to 86ºF) [See USP Controlled Room Temperature].

Keep out of reach of children.

📋 Description 137 words ▾

11 DESCRIPTION Gabapentin tablet contains gabapentin, a gamma-aminobutyric acid (GABA) analogue, as the active pharmaceutical ingredient. Gabapentin's chemical name is 1-(aminomethyl)cyclohexaneacetic acid; with a molecular formula of C 9 H 17 NO 2 and a molecular weight of 171.24 g/mol. Gabapentin chemical structural formula is: Gabapentin, USP is a white to off-white, crystalline powder with a pKa1 of 3.7 and a pKa2 of 10.7.

It is freely soluble in water and in alkaline and acidic solutions. The log of the partition coefficient (n-octanol/ 0.05M phosphate buffer) at pH 7.4 is -1.25. Each gabapentin tablet intended for oral administration contains 300 mg, 450 mg, 600 mg, 750 mg or 900 mg of gabapentin.

In addition, each tablet contains the following inactive ingredients: copovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyethylene oxide, povidone, talc and titanium dioxide. Image

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise patients of the availability of a Medication Guide, and instruct them to read the Medication Guide prior to taking gabapentin tablets. Advise patients that once-daily gabapentin tablets are not substitutable with other formulations of gabapentin. Advise patients to take gabapentin only as prescribed.

Gabapentin may cause dizziness, somnolence, and other signs and symptoms of CNS depression. Advise patients not to drive or operate other complex machinery until they have gained sufficient experience on gabapentin to gauge whether or not it adversely affects their mental and/or motor performance. Advise patients who require concomitant treatment with morphine to tell their prescriber if they develop signs of CNS depression such as somnolence.

If this occurs the dose of gabapentin or morphine should be reduced accordingly. Advise patients that if they miss a dose of gabapentin to take it with food as soon as they remember. If it is almost time for the next dose, just skip the missed dose and take the next dose at the regular time.

Do not take two doses at the same time. Advise patients that if they take too much gabapentin, to call their healthcare provider or poison control center, or go to the nearest emergency room right away. Suicidal Thoughts and Behavior Counsel patients, their caregivers, and families that AEDs, including gabapentin, the active ingredient in gabapentin tablet, may increase the risk of suicidal thoughts and behavior and of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm.

Instruct patients, caregivers, and families to report behaviors of concern immediately to healthcare providers. Also inform patients who plan to or have discontinued gabapentin tablets that suicidal thoughts and behavior can appear even after the drug is stopped [see Warnings and Precautions ( 5.1 )]. Respiratory Depression Inform patients about the risk of respiratory depression.

Include information that the risk is greatest for those using concomitant central nervous system (CNS) depressants (such as opioid analgesics) or in those with underlying respiratory impairment. Teach patients how to recognize respiratory depression and advise them to seek medical attention immediately if it occurs [see Warnings and Precautions ( 5.3 )]. Dosing and Administration Gabapentin is not substitutable with other gabapentin products because of differing pharmacokinetic profiles that affect the frequency of administration.

The safety and effectiveness of gabapentin in patients with epilepsy has not been studied. Advise patients that gabapentin should be taken orally once-daily with the evening meal. Gabapentin tablets should be swallowed whole.

Do not split, crush, or chew the tablets [see Dosage and Administration ( 2.1 )]. Use in Pregnancy Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with gabapentin tablets and to notify their physician if they are breast feeding or intend to breast feed during therapy [see Use in Specific Populations ( 8.1 ) and ( 8.2 )]. Encourage patients to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry if they become pregnant.

This registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll-free number 1-888-233- 2334 [see Use in Specific Populations ( 8.1 )]. ® is the registered trademark of its owner. Medication Guide available at www.zydususa.com/medguides or call 1-877-993-8779.

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Gabapentin (gab" a pen' tin) Tablets Read this Medication Guide before you start taking gabapentin and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

If you have any questions about gabapentin, ask your healthcare provider or pharmacist. What is the most important information I should know about gabapentin? Do not stop taking gabapentin without first talking with your healthcare provider.

Stopping gabapentin suddenly can cause serious problems. Like other antiepileptic drugs, gabapentin, the active ingredient in gabapentin tablet, may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. This can happen while you take gabapentin tablet or after stopping.

However, it is not known if gabapentin is safe and effective in people with seizure problems (epilepsy). Therefore, gabapentin tablet should not be used in place of other gabapentin products. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying attempts to commit suicide serious breathing problems new or worse depression new or worse anxiety feeling agitated or restless panic attacks trouble sleeping (insomnia) new or worse irritability acting aggressive, being angry, or violent acting on dangerous impulses an extreme increase in activity and talking (mania) other unusual changes in behavior or mood How can I watch for early symptoms of suicidal thoughts and actions?

Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

Serious breathing problems Serious breathing problems can occur when gabapentin is taken with other medicines that can cause severe sleepiness or decreased awareness, or when it is taken by someone who already has breathing problems. Watch for increased sleepiness or decreased breathing when starting gabapentin or when the dose is increased. Get help right away if breathing problems occur.

Do not stop taking gabapentin without first talking with your healthcare provider. Stopping gabapentin suddenly can cause serious problems. What is gabapentin?

Gabapentin is a prescription medicine used in adults, 18 years and older, to treat: pain from damaged nerves (neuropathic pain) that follows healing of shingles (a painful rash that comes after a herpes zoster infection). It is not known if gabapentin is safe and effective in people with seizure problems (epilepsy). It is not known if gabapentin is safe and effective in children under 18 years of age with postherpetic pain.

Gabapentin tablet is not substitutable with other gabapentin products. Who should not take gabapentin? Do not take gabapentin tablet if you are allergic to gabapentin or any of the ingredients in gabapentin tablet.

See the end of this Medication Guide for a complete list of ingredients in gabapentin tablet. What should I tell my healthcare provider before taking gabapentin? Before taking gabapentin, tell your healthcare provider if you: have or have had depression, mood problems or suicidal thoughts or behavior have breathing problems have seizures have kidney problems or get kidney dialysis are pregnant or plan to become pregnant.

It is not known if gabapentin can harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking gabapentin. You and your healthcare provider will decide if you should take gabapentin while you are pregnant.

If you become pregnant while taking gabapentin, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safet… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 71 words ▾

8.2Lactation Risk Summary Gabapentin is present in human milk following oral administration. Adverse effects on the breastfed infant have not been reported. There are no data on the effects of the drug on milk production.

The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for gabapentin and any potential adverse effects on the breastfed infant from gabapentin or from the underlying maternal condition.

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Absorption Gabapentin is absorbed from the proximal small bowel by a saturable L-amino transport system. Gabapentin bioavailability is not dose proportional; as the dose is increased, bioavailability decreases. When gabapentin (1,800 mg once daily) and gabapentin immediate release (600 mg three times a day) were administered with high fat meals (50% of calories from fat), gabapentin has a higher C max and lower AUC at steady state compared to gabapentin immediate release (Table 5).

Time to reach maximum plasma concentration (T max ) for gabapentin is 8 hours, which is about 4 hours to 6 hours longer compared to gabapentin immediate release. Table 5 Mean ± SD Steady-State Pharmacokinetics for Gabapentin and Gabapentin Immediate Release in Healthy Subjects under high-fat high calorie fed state (Day 5, n = 21) $ T max is presented as median (range); * relative to most recent dose Pharmacokinetic Parameter (Mean ± SD) Gabapentin 1,800 mg QD (3 x 600 mg) Gabapentin Immediate Release 600 mg TID AUC0-24 (mcg hr/mL) 132.8 ± 34.7 141.3 ±

29.8C max (mcg/mL) 9.59 ± 2.33 8.54 ±

1.72C min (mcg/mL) 1.84 ± 0.65 2.6 ±

0.78T max (hr) $ 8 (3 to 12) 2 (1 to 5)* The single dose pharmacokinetic parameters of 900 mg strength under high fat-high calorie fed state and low fat-low calorie fed state are presented shown in Table 6. Mean ± SD Single-Dose Pharmacokinetic parameters for Gabapentin 900 mg strength in Healthy Subjects (n = 27) $ Tmax is presented as median (range) Pharmacokinetic Parameter (Mean ± SD) Gabapentin 1,800 mg (2 x 900 mg tablets) High fat- high calorie fed state Low fat- low calorie fed state C max (mcg/mL) 9.49 ± 1.93 6.50 ±

2.16AUCt (mcg hr/mL) 127.2 ± 42.8 79.1 ±

39.4AUCinf (mcg.hr/mL) 133.2 ± 43.2 84.8 ±

39.4T max (hr) $ 7 (4-12) 4 (3-12) Do not use once-daily gabapentin tablets as a substitute for other gabapentin products because of differing pharmacokinetic profiles that affect frequency of administration. Gabapentin should be taken with evening meals. If it is taken on an empty stomach, the bioavailability will be substantially lower.

Administration of gabapentin with food increases the rate and extent of absorption of gabapentin compared to the fasted state. C max of gabapentin increases 33% to 84% and AUC of gabapentin increases 33% to 118% with food depending on the fat content of the meal. Gabapentin should be taken with food .

Distribution Gabapentin is less than 3% bound to plasma proteins. After 150 mg intravenous administration, the mean ± SD volume of distribution is 58 ± 6 L. Elimination Gabapentin is eliminated by renal excretion as unchanged drug.

In patients with normal renal function given gabapentin immediate release 1,200 to 3,000 mg/day, the drug elimination half-life (t 1/2 ) was 5 hours to 7 hours. Elimination kinetics do not change with dose level or multiple doses. Metabolism Gabapentin is not appreciably metabolized in humans.

Excretion Gabapentin elimination rate constant, plasma clearance, and renal clearance are directly proportional to creatinine clearance. In elderly patients and patients with impaired renal function, plasma clearance is reduced. Gabapentin can be removed from plasma by hemodialysis.

Dosage adjustment in patients with compromised renal function is necessary. In patients undergoing hemodialysis, gabapentin should not be administered [see Dosage and Administration ( 2.2 )].

🧬 Pharmacodynamics 10 words ▾

12.2Pharmacodynamics No pharmacodynamic studies have been conducted with gabapentin.

🔬 Clinical Studies ~1 min read ▾

14 CLINICAL STUDIES The efficacy of gabapentin for the management of postherpetic neuralgia was established in a double-blind, placebo-controlled, multicenter study. This study enrolled patients between the age of 21 to 89 with postherpetic neuralgia persisting for at least 6 months following healing of herpes zoster rash and a minimum baseline pain intensity score of at least 4 on an 11-point numerical pain rating scale ranging from 0 (no pain) to 10 (worst possible pain). This 11-week study compared gabapentin 1,800 mg once daily with placebo.

A total of 221 and 231 patients were treated with gabapentin or placebo, respectively. The study treatment including titration for all patients comprised a 10-week treatment period followed by 1-week of dose tapering. Double-blind treatment began with titration starting at 300 mg/day and titrated up to a total daily dose of 1,800 mg over 2 weeks, followed by 8 weeks fixed dosing at 1,800 mg once daily, and then 1 week of dose tapering.

During the 8-week stable dosing period, patients took 3 active or placebo tablets each night with the evening meal. During baseline and treatment, patients recorded their pain in a daily diary using an 11-point numeric pain rating scale. The mean baseline pain score was 6.6 and 6.5 for gabapentin and placebo-treated patients, respectively.

Treatment with gabapentin statistically significantly improved the endpoint mean pain score from baseline. For various degrees of improvement in pain from baseline to study endpoint, Figure 1 shows the fraction of patients achieving that degree of improvement. The figure is cumulative, so that patients whose change from baseline is, for example, 50%, are also included at every level of improvement below 50%.

Patients who did not complete the study were assigned 0% improvement. Figure 1: Percent of Patients Achieving Various Levels of Pain Relief Image

🔒 Drug Abuse and Dependence 134 words ▾

9 DRUG ABUSE AND DEPENDENCE

9.1Controlled Substance Gabapentin tablets contains gabapentin, which is not a controlled substance.

9.3Dependence Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. After discontinuation of short-term and long-term treatment with gabapentin, withdrawal symptoms have been observed in some patients. Withdrawal symptoms may occur shortly after discontinuation, usually within 48 hours.

In the postmarketing setting, reported adverse reactions have included, but not been limited to, seizures, depression, suicidal ideation and behavior, agitation, confusion, disorientation, psychotic symptoms, anxiety, insomnia, nausea, pain, sweating, tremor, headache, dizziness, and malaise. The abuse and dependence potential of gabapentin tablets has not been evaluated in human studies.

🧪 Nonclinical Toxicology ~2 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Gabapentin was given in the diet to mice at 200, 600, and 2,000 mg/kg/day and to rats at 250, 1,000 and 2,000 mg/kg/day for 2 years. A statistically significant increase in the incidence of pancreatic acinar cell adenoma and carcinomas was found in male rats receiving the high dose; the no-effect dose for the occurrence of carcinomas was 1,000 mg/kg/day. Peak plasma concentrations of gabapentin in rats receiving the high dose of 2,000 mg/kg/day were more than 10 times higher than plasma concentrations in humans receiving 1,800 mg per day and in rats receiving 1,000 mg/kg/day peak plasma concentrations were more than 6.5 times higher than in humans receiving 1,800 mg/day.

The pancreatic acinar cell carcinomas did not affect survival, did not metastasize and were not locally invasive. The relevance of this finding to carcinogenic risk in humans is unclear. Studies designed to investigate the mechanism of gabapentin-induced pancreatic carcinogenesis in rats indicate that gabapentin stimulates DNA synthesis in rat pancreatic acinar cells in vitro and, thus, may be acting as a tumor promoter by enhancing mitogenic activity.

It is not known whether gabapentin has the ability to increase cell proliferation in other cell types or in other species, including humans. Mutagenesis Gabapentin did not demonstrate mutagenic or genotoxic potential in 3 in vitro and 4 in vivo assays. It was negative in the Ames test and the in vitro HGPRT forward mutation assay in Chinese hamster lung cells; it did not produce significant increases in chromosomal aberrations in the in vitro Chinese hamster lung cell assay; it was negative in the in vivo chromosomal aberration assay and in the in vivo micronucleus test in Chinese hamster bone marrow; it was negative in the in vivo mouse micronucleus assay; and it did not induce unscheduled DNA synthesis in hepatocytes from rats given gabapentin.

Impairment of Fertility No adverse effects on fertility or reproduction were observed in rats at doses up to 2,000 mg/kg (approximately 11 times the maximum recommended human dose on an mg/m 2 basis).

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~2 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Gabapentin was given in the diet to mice at 200, 600, and 2,000 mg/kg/day and to rats at 250, 1,000 and 2,000 mg/kg/day for 2 years. A statistically significant increase in the incidence of pancreatic acinar cell adenoma and carcinomas was found in male rats receiving the high dose; the no-effect dose for the occurrence of carcinomas was 1,000 mg/kg/day. Peak plasma concentrations of gabapentin in rats receiving the high dose of 2,000 mg/kg/day were more than 10 times higher than plasma concentrations in humans receiving 1,800 mg per day and in rats receiving 1,000 mg/kg/day peak plasma concentrations were more than 6.5 times higher than in humans receiving 1,800 mg/day.

The pancreatic acinar cell carcinomas did not affect survival, did not metastasize and were not locally invasive. The relevance of this finding to carcinogenic risk in humans is unclear. Studies designed to investigate the mechanism of gabapentin-induced pancreatic carcinogenesis in rats indicate that gabapentin stimulates DNA synthesis in rat pancreatic acinar cells in vitro and, thus, may be acting as a tumor promoter by enhancing mitogenic activity.

It is not known whether gabapentin has the ability to increase cell proliferation in other cell types or in other species, including humans. Mutagenesis Gabapentin did not demonstrate mutagenic or genotoxic potential in 3 in vitro and 4 in vivo assays. It was negative in the Ames test and the in vitro HGPRT forward mutation assay in Chinese hamster lung cells; it did not produce significant increases in chromosomal aberrations in the in vitro Chinese hamster lung cell assay; it was negative in the in vivo chromosomal aberration assay and in the in vivo micronucleus test in Chinese hamster bone marrow; it was negative in the in vivo mouse micronucleus assay; and it did not induce unscheduled DNA synthesis in hepatocytes from rats given gabapentin.

Impairment of Fertility No adverse effects on fertility or reproduction were observed in rats at doses up to 2,000 mg/kg (approximately 11 times the maximum recommended human dose on an mg/m 2 basis).

📄 Recent Major Changes 12 words ▾

RECENT MAJOR CHANGES Warnings and Precautions ( 5.1 , 5.2 ) 04/2025

📄 Package Label / Principal Display Panel 66 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Gabapentin Tablets, 300 mg 90 Tablets NDC 68382-608-16 Rx only Zydus Gabapentin Tablets, 450 mg 60 Tablets NDC 68382-355-14 Rx only Zydus Gabapentin Tablets, 750 mg 60 Tablets NDC 68382-356-14 Rx only Zydus Gabapentin Tablets, 600 mg 90 Tablets NDC 68382-607-16 Rx only Zydus Gabapentin Tablets, 900 mg 60 Tablets NDC 68382-357-14 Rx only Zydus 300 mg gabapentin450mg gabapentin750mg 600 mg gabapentin900mg

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
90 tablets68382-0607-16 579 Rx · $76,881
500 tablets this page68382-0607-05 No Medicaid data
100 tablets68382-0607-77 No Medicaid data
Drug total (last 4 qtrs): 579 Rx · 36,742 units · $76,881 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Gabapentin — the program that covers self-administered drugs. 41 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Gabapentin. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$151.2M
Claims incl. refills
8.9M
Beneficiaries
5.1M
Spend / beneficiary
$29.73
Spend / claim
$16.90
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Zydus Pharmaceuticals USA Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 90 tablets (68382-0607-16), 100 tablets (68382-0607-77). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Zydus Pharmaceuticals USA Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 68382-0599-01 · Zydus 68382-0608-05 · Zydus →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.