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Gabapentin 600 mg Tablet, 60-count — NDC 71335-3060-02 package photo

Gabapentin 600 mg Tablet, 60-count

by Bryant Ranch Prepack · 60 TABLET in 1 BOTTLE (71335-3060-2)
NDC 71335-3060-02
🏷️ FDA NDC (as labeled) 71335-3060-2 billing pads the package segment with a zero
This package
Contains60-count Pack sizes10 compare ↓
Also priced by: Part D plans $0.1683/unit — full pricing hub ↓
Also comes in: 28 tablets 71335-3060-00 30 tablets 71335-3060-01 84 tablets 71335-3060-08 90 tablets 71335-3060-04 100 tablets 71335-3060-05 112 tablets 71335-3060-09 120 tablets 71335-3060-06 180 tablets 71335-3060-03 500 tablets 71335-3060-07
Rx only Generic On market Non-controlled
🗂️ Data synced 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

FDA NDC (as labeled) 71335-3060-2
Product NDC 71335-3060
11-digit billing NDC 71335306002
NCPDP billing unit EA — each (per item)
RxCUI 310433
UNII 6CW7F3G59X
Application # ANDA217995
SPL Set ID cc1998a7-7004-4688-8b5b-525041851d1d
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 2024-04-04
Route ORAL
Dosage form TABLET
Substance GABAPENTIN
GCN Seq No 041805
GCN 94624
HICL code 008831
Ingredient (HICL) Gabapentin
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H4
Therapeutic class — intermediate (HIC2) Anticonvulsants
HIC3 code H4B
Therapeutic class — specific (HIC3) Anticonvulsants
AHFS code 28:08.92.00
AHFS class Analgesics And Antipyretics, Misc.
FDB label name GABAPENTIN 600 MG TABLET
FDB brand name Gabapentin
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB1 · RLD · RS
Why two NDCs? The FDA registers this code as 71335-3060-2 — a 5-4-1 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 package segment → 71335-3060-02. 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.

🏭 Manufacturer & labeler

LabelerBryant Ranch Prepack
Application holderRISING PHARMA HOLDINGS INC
FDA applicationANDA217995 (ANDA)
Labeler code71335
First marketedApr 2024
Product typeHuman Prescription Drug
Portfolio4,432 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.

🩺 Clinical

Label name GABAPENTIN 600 MG TABLET Ingredient Gabapentin
📖 What it is MedlinePlus · NLM

Gabapentin capsules, tablets, and oral solution are used along with other medications to help control certain types of seizures in people who have epilepsy. Gabapentin capsules, tablets, and oral solution are also used to relieve the pain of postherpetic neuralgia (PHN; the burning, stabbing pain or aches that may last for months or years after an attack of shingles). Gabapentin extended-release tablets (Horizant) are used to treat restless legs syndrome (RLS; a condition that causes discomfort in the legs and a strong urge to move the legs, especially at night and when sitting or lying down)....

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Gabapentin is mainly used for two things: managing nerve pain that lingers after a shingles infection (called postherpetic neuralgia) in adults, and helping control partial onset s...
  • This is a really important question. Taking gabapentin together with opioids like morphine, hydrocodone, or oxycodone significantly raises the risk of serious breathing problems —...
  • Can I take gabapentin with my opioid pain medication?
  • The most common ones — especially in the first few weeks — are dizziness, drowsiness, and sometimes loss of balance or coordination. Swelling in the feet or hands is also fairly co...
📖 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.

💊 What it looks like

Color White
ShapeOval
Imprint7;5
Size17 mm
ScoringScored — splits in 2
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.

💲 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 $0.1683 $10.10 / 60 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Gabapentin 600 mg 00904-6823-61 Major 1 tablet $0.064 AB1 Availability likely —
Gabapentin 600 mg 16571-0226-01 Rising 100 tablets $0.064 AB1 Availability likely —
Gabapentin 600 mg 16714-0330-01 NorthStar 100 tablets $0.064 AB1 Availability likely —
Gabapentin 600 mg 31722-0166-01 Camber 100 tablets $0.064 AB1 Availability likely —
Gabapentin 600 mg 50228-0177-01 ScieGen 100 tablets $0.064 AB1 Availability likely —
Gabapentin 600 mg 50268-0325-15 AvPAK 1 tablet $0.064 AB1 Availability likely —
Gabapentin 600 mg 60687-0507-01 American 1 tablet $0.064 AB1 Availability likely —
Gabapentin 600 mg 64380-0727-01 Strides 100 tablets $0.064 AB1 Availability likely —
Gabapentin 600 mg 65862-0523-01 Aurobindo 100 tablets $0.064 — Availability likely —
Gabapentin 600 mg 67877-0428-01 Ascend 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 68382-0204-01 Zydus 100 tablets $0.064 AB1 Availability likely —
Gabapentin 600 mg 68462-0126-01 Glenmark 100 tablets $0.064 AB1 Availability likely —
Gabapentin 600 mg 69367-0346-05 Westminster 500 tablets $0.064 AB1 Availability likely —
Gabapentin 600 mg 70010-0227-01 Granules 100 tablets $0.064 AB1 Availability likely —
Gabapentin 600 mg 71093-0111-04 ACI 100 tablets $0.064 AB1 Availability likely —
Gabapentin 600 mg 76282-0405-01 Exelan 100 tablets $0.064 — Availability likely —
Gabapentin 600 mg 76282-0706-05 Exelan 500 tablets $0.064 AB1 Availability likely —
Gabapentin 600 mg 82009-0071-05 QUALLENT 500 tablets $0.064 AB1 Availability likely —
Gabapentin 600 mg 83301-0001-01 Mullan 100 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 $0.943 AB2 Availability likely —
Gabapentin 600 mg 42806-0657-09 Epic 90 tablets $0.943 AB2 Availability likely —
Gralise 600 mg 52427-0806-90 Almatica 90 tablets $10.158 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 $14.084 AB1 Availability likely —
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 50090-6855-00 A-S 90 tablets — AB1 FDA listed —
Gabapentin 600 mg 50090-7268-00 A-S 90 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 50090-7715-00 A-S 90 tablets — AB1 FDA listed —
Gabapentin 600 mg 55154-3357-00 Cardinal 1 tablet — AB1 FDA listed —
Gabapentin 600 mg 55154-8189-00 Cardinal 1 tablet — AB1 FDA listed —
Gabapentin 600 mg 55289-0959-30 PD-Rx 30 tablets — AB1 FDA listed —
Gabapentin 600 mg 58118-0166-08 Clinical 30 tablets — AB1 FDA listed —
Gabapentin 600 mg 60760-0066-60 St. 60 tablets — AB1 Discontinued —
Gabapentin 600 mg 60760-0743-90 St. 90 tablets — AB1 FDA listed —
Gabapentin 600 mg 60760-0987-90 St. 90 tablets — AB1 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 63629-3063-00 Bryant 45 tablets — AB1 FDA listed —
Gabapentin 600 mg 63629-7307-01 Bryant 90 tablets — AB1 FDA listed —
Gabapentin 600 mg 63629-8491-01 Bryant 500 tablets — AB1 FDA listed —
Gabapentin 600 mg 63629-8492-01 Bryant 100 tablets — AB1 FDA listed —
Gabapentin 600 mg 65841-0705-01 Zydus 100 tablets — AB1 FDA listed —
Gabapentin 600 mg 67046-1535-03 Coupler 30 tablets — AB1 FDA listed —
Gabapentin 600 mg 68071-3445-03 NuCare 30 tablets — AB1 FDA listed —
Gabapentin 600 mg 68071-3783-09 NuCare 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 69097-0812-02 Cipla 30 tablets — — FDA listed —
Gabapentin 600 mg 70518-2098-00 REMEDYREPACK 30 tablets — AB1 FDA listed —
Gabapentin 600 mg 70518-2356-00 REMEDYREPACK 30 tablets — AB1 FDA listed —
Gabapentin 600 mg 70518-2616-03 REMEDYREPACK 30 tablets — AB1 Discontinued —
Gabapentin 600 mg 70518-2842-00 REMEDYREPACK 28 tablets — AB1 Discontinued —
Gabapentin 600 mg 70518-4532-00 REMEDYREPACK 1 tablet — AB1 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 71335-1026-01 Bryant 90 tablets — AB1 Discontinued —
Gabapentin 600 mg 71335-1132-00 Bryant 28 tablets — AB1 Discontinued —
Gabapentin 600 mg 71335-1200-00 Bryant 28 tablets — AB1 FDA listed —
Gabapentin 600 mg 71335-1287-00 Bryant 28 tablets — AB1 FDA listed —
Gabapentin 600 mg 71335-2048-01 Bryant 90 tablets — AB1 FDA listed —
Gabapentin 600 mg 71335-2281-01 Bryant 500 tablets — AB1 FDA listed —
Gabapentin 600 mg 71335-2701-00 Bryant 28 tablets — AB1 FDA listed —
Gabapentin 600 mg 71335-2719-01 Bryant 90 tablets — AB1 FDA listed —
Gabapentin 600 mgthis 71335-3060-02 Bryant 60 tablets — AB1 FDA listed —
Gabapentin 600 mg 71335-3143-01 Bryant 90 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 71610-0767-30 Aphena 30 tablets — AB1 FDA listed —
Gabapentin 600 mg 71610-0777-30 Aphena 30 tablets — AB1 FDA listed —
Gabapentin 600 mg 72162-1530-01 Bryant 100 tablets — AB1 FDA listed —
Gabapentin 600 mg 72162-2141-01 Bryant 100 tablets — AB1 FDA listed —
Gabapentin 600 mg 72189-0313-60 Directrx 60 tablets — AB1 FDA listed —
Gabapentin 600 mg 72189-0471-30 Direct_Rx 30 tablets — AB1 FDA listed —
Gabapentin 600 mg 72789-0127-30 PD-Rx 30 tablets — AB1 FDA listed —
Gabapentin 600 mg 72865-0255-05 XLCare 500 tablets — AB1 FDA listed —
Gabapentin 600 mg 72888-0131-00 Advagen 1000 tablets — AB1 FDA listed —
Gabapentin 600 mg 76420-0235-12 Asclemed 120 tablets — AB1 FDA listed —
Gabapentin 600 mg 76420-0836-01 Asclemed 100 tablets — AB1 FDA listed —
Gabapentin 600 mg 77771-0177-05 Radha 500 tablets — AB1 FDA listed —
Gabapentin 600 mg 80425-0097-01 Advanced 30 tablets — AB1 FDA listed —
Gabapentin 600 mg 80425-0201-01 Advanced 30 tablets — AB1 FDA listed —
Gabapentin 600 mg 82619-0145-01 Creekwood 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 82804-0210-90 Proficient 90 tablets — AB1 FDA listed —
Gabapentin 600 mg 83008-0063-60 Quality 60 tablets — AB1 Discontinued —
Gabapentin 600 mg 87441-0036-01 Unit 30 tablets — AB1 FDA listed —
gabapentin 600 mg 50228-0524-05 ScieGen 500 tablets — AB2 FDA listed —
gabapentin 600 mg 68382-0607-05 Zydus 500 tablets — AB2 FDA listed —
gabapentin 600 mg 70771-1862-04 Zydus 100 tablets — AB2 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 —
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
Apr 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.

📊 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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Gabapentin — the ingredient across all brands.

Top reported reactions

Fatigue24,972
Nausea22,728
Pain21,181
Diarrhoea18,114
Headache17,897
Dizziness16,238
Fall15,536

Reporter sex

361,481 reports
Male · 35%
Female · 65%
Unknown · 0%

Serious outcomes

Life-threatening10,681
Disabling9,725
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 32,285 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
71335-3060-00 28 TABLET in 1 BOTTLE (71335-3060-0) 2026-02-05 Active
71335-3060-01 30 TABLET in 1 BOTTLE (71335-3060-1) 2026-02-05 Active
71335-3060-02 You're viewing this 60 TABLET in 1 BOTTLE (71335-3060-2) 2026-02-05 Active
71335-3060-03 180 TABLET in 1 BOTTLE (71335-3060-3) 2026-02-05 Active
71335-3060-04 90 TABLET in 1 BOTTLE (71335-3060-4) 2026-02-05 Active
71335-3060-05 100 TABLET in 1 BOTTLE (71335-3060-5) 2026-02-05 Active
71335-3060-06 120 TABLET in 1 BOTTLE (71335-3060-6) 2026-02-05 Active
71335-3060-07 500 TABLET in 1 BOTTLE (71335-3060-7) 2026-02-05 Active
71335-3060-08 84 TABLET in 1 BOTTLE (71335-3060-8) 2026-02-05 Active
71335-3060-09 112 TABLET in 1 BOTTLE (71335-3060-9) 2026-02-05 Active

You're viewing one of 10 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 71335-3060-02?
NDC 71335-3060-02 is a 60-count package — 60 tablet in 1 bottle.
What is the difference between NDC 71335-3060-02 and NDC 71335-3060-00?
Both are Gabapentin 600 mg Tablet — the drug itself is identical. NDC 71335-3060-02 is the 60-count package, while NDC 71335-3060-00 is the 28 tablets package.
What NDC number is used to bill for this package of Gabapentin 600 mg Tablet?
Bill NDC 71335-3060-02 — the 11-digit billing format is 71335306002. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 FDA registers it as 71335-3060-2, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 71335-3060-02, written without dashes as 71335306002. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 71335-3060-02, the first segment (71335) is the labeler code FDA assigned to Bryant Ranch Prepack; the middle segment (3060) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Bryant Ranch Prepack. 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 9 other package presentations of this same product, including 28 tablets (71335-3060-00), 30 tablets (71335-3060-01), 84 tablets (71335-3060-08). 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?
Bryant Ranch Prepack 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.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. 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 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🎯 Indications and Usage 80 words ▾

1 INDICATIONS AND USAGE Gabapentin Tablets are indicated for: Management of postherpetic neuralgia in adults Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy Gabapentin tablets are indicated for: Postherpetic neuralgia in adults ( 1 ) Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Postherpetic Neuralgia ( 2.1 ) Dose can be titrated up as needed to a dose of 1,800 mg/day Day 1: Single 300 mg dose Day 2: 600 mg/day (i.e., 300 mg two times a day) Day 3: 900 mg/day (i.e., 300 mg three times a day) Epilepsy with Partial Onset Seizures ( 2.2 ) Patients 12 years of age and older: starting dose is 300 mg three times daily; may be titrated up to 600 mg three times daily Patients 3 to 11 years of age: starting dose range is 10 to 15 mg/kg/day, given in three divided doses; recommended dose in patients 3 to 4 years of age is 40 mg/kg/day, given in three divided doses; the recommended dose in patients 5 to 11 years of age is 25 to 35 mg/kg/day, given in three divided doses.

The recommended dose is reached by upward titration over a period of approximately 3 days Dose should be adjusted in patients with reduced renal function ( 2.3 , 2.4 )

2.1Dosage for Postherpetic Neuralgia In adults with postherpetic neuralgia, gabapentin tablets may be initiated on Day 1 as a single 300 mg dose, on Day 2 as 600 mg/day (300 mg two times a day), and on Day 3 as 900 mg/day (300 mg three times a day). The dose can subsequently be titrated up as needed for pain relief to a dose of 1,800 mg/day (600 mg three times a day). In clinical studies, efficacy was demonstrated over a range of doses from 1,800 mg/day to 3,600 mg/day with comparable effects across the dose range; however, in these clinical studies, the additional benefit of using doses greater than 1,800 mg/day was not demonstrated.

2.2Dosage for Epilepsy with Partial Onset Seizures Patients 12 Years of Age and Above The starting dose is 300 mg three times a day. The recommended maintenance dose of gabapentin tablets is 300 mg to 600 mg three times a day. Dosages up to 2,400 mg/day have been administered in long-term clinical studies.

Doses of 3,600 mg/day have also been administered to a small number of patients for a relatively short duration. Administer gabapentin tablets three times a day using 600 mg or 800 mg tablets. The maximum time between doses should not exceed 12 hours.

Pediatric Patients Age 3 to 11 Years The starting dose range is 10 mg/kg/day to 15 mg/kg/day, given in three divided doses, and the recommended maintenance dose reached by upward titration over a period of approximately 3 days. The recommended maintenance dose of gabapentin tablets in patients 3 to 4 years of age is 40 mg/kg/day, given in three divided doses. The recommended maintenance dose of gabapentin tablets in patients 5 to 11 years of age is 25 mg/kg/day to 35 mg/kg/day, given in three divided doses.

Gabapentin may be administered as the oral solution, capsule, or tablet, or using combinations of these formulations. Dosages up to 50 mg/kg/day have been administered in a long-term clinical study. The maximum time interval between doses should not exceed 12 hours.

2.3Dosage Adjustment in Patients with Renal Impairment Dosage adjustment in patients 12 years of age and older with renal impairment or undergoing hemodialysis is recommended, as follows (see dosing recommendations above for effective doses in each indication): TABLE 1. GABAPENTIN Dosage Based on Renal Function TID = Three times a day; BID = Two times a day; QD = Single daily dose a For patients with creatinine clearance <15 mL/min, reduce daily dose in proportion to creatinine clearance (e.g., patients with a creatinine clearance of 7.5 mL/min should receive one-half the daily dose that patients with a creatinine clearance of 15 mL/min receive). b Patients on hemodialysis should receive maintenance doses based on estimates of creatinine clearance as indicated in the upper portion of the table and a supplemental post-hemodialysis dose administered after each 4 hours of hemodialysis as indicated in the lower portion of the table.

Renal Function Creatinine Clearance (mL/min) Total Daily Dose Range (mg/day) Dose Regimen (mg) ≥60 900 to 3,600 300 TID 400 TID 600 TID 800 TID 1,200 TID >30 to 59 400 to 1,400 200…

💊 Dosage Forms and Strengths 45 words ▾

3 DOSAGE FORMS AND STRENGTHS Tablets 600 mg: White elliptical film-coated scored tablets debossed with "7" and "5" on one side 800 mg: White elliptical film-coated scored tablets debossed with "3" and "7" on one side. Tablets: 600 mg, and 800 mg ( 3 )

⛔ Contraindications 28 words ▾

4 CONTRAINDICATIONS Gabapentin tablets are contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. Known hypersensitivity to gabapentin or its ingredients ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Drug Reaction with Eosinophilia and Systemic Symptoms (Multiorgan hypersensitivity): Discontinue if alternative etiology is not established ( 5.1 ) Anaphylaxis and Angioedema: Discontinue and evaluate patient immediately ( 5.2 ) Driving Impairment; Somnolence/Sedation and Dizziness: Warn patients not to drive until they have gained sufficient experience to assess whether their ability to drive or operate heavy machinery will be impaired ( 5.3 , 5.4 ) Suicidal Behavior and Ideation: Monitor for suicidal thoughts/behavior (5.5) Abrupt or rapid discontinuation may increase the risk for seizures.

Withdrawal symptoms, or suicidal behavior and ideation have been observed after discontinuation (5.6) Respiratory Depression: May occur with gabapentin when used with concomitant central nervous system (CNS) depressants, including opioids, or in the setting of underlying respiratory impairment. Monitor patients and adjust dosage as appropriate (5.8) Neuropsychiatric Adverse Reactions in Children 3 to 12 Years of Age: Monitor for such events (5.9)

5.1Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multiorgan hypersensitivity, has occurred with gabapentin. Some of these reactions have been fatal or life-threatening. DRESS typically, although not exclusively, presents with fever, rash, and/or lymphadenopathy, in association with other organ system involvement, such as hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis sometimes resembling an acute viral infection.

Eosinophilia is often present. This disorder is variable in its expression, and other organ systems not noted here may be involved. It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident.

If such signs or symptoms are present, the patient should be evaluated immediately. Gabapentin should be discontinued if an alternative etiology for the signs or symptoms cannot be established.

5.2Anaphylaxis and Angioedema Gabapentin can cause anaphylaxis and angioedema after the first dose or at any time during treatment. Signs and symptoms in reported cases have included difficulty breathing, swelling of the lips, throat, and tongue, and hypotension requiring emergency treatment. Patients should be instructed to discontinue gabapentin and seek immediate medical care should they experience signs or symptoms of anaphylaxis or angioedema.

5.3Effects on Driving and Operating Heavy Machinery Patients taking gabapentin should not drive until they have gained sufficient experience to assess whether gabapentin impairs their ability to drive. Driving performance studies conducted with a prodrug of gabapentin (gabapentin enacarbil tablet, extended-release) indicate that gabapentin may cause significant driving impairment. Prescribers and patients should be aware that patients' ability to assess their own driving competence, as well as their ability to assess the degree of somnolence caused by gabapentin, can be imperfect.

The duration of driving impairment after starting therapy with gabapentin is unknown. Whether the impairment is related to somnolence [see Warnings and Precautions ( 5.4 )] or other effects of gabapentin is unknown. Moreover, because gabapentin causes somnolence and dizziness [see Warnings and Precautions ( 5.4 )] , patients should be advised not to operate complex machinery until they have gained sufficient experience on gabapentin to assess whether gabapentin impairs their ability to perform such tasks.

5.4Somnolence/Sedation and Dizziness During the controlled epilepsy trials in patients older than 12 years of age receiving doses of gabapentin up to 1,800 mg daily, somnolence, dizziness, and ataxia were reported at a greater rate in patients receiving gabapentin compared to placebo: i.e., 19% in drug versus 9% in pla…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections: Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity [see Warnings and Precautions ( 5.1 )] Anaphylaxis and Angioedema [see Warnings and Precautions ( 5.2 )] Somnolence/Sedation and Dizziness [see Warnings and Precautions ( 5.4 )] Suicidal Behavior and Ideation [see Warnings and Precautions (5.5)] Increased Risk of Seizures and Other Adverse Reactions with Abrupt or Rapid Discontinuation [see Warnings and Precautions (5.6)] Status Epilepticus [see Warnings and Precautions (5.7)] Respiratory Depression [see Warnings and Precautions (5.8)] Neuropsychiatric Adverse Reactions (Pediatric Patients 3 to 12 Years of Age) [see Warnings and Precautions (5.9)] Most common adverse reactions (incidence ≥8% and at least twice that for placebo) were: Postherpetic neuralgia: Dizziness, somnolence, and peripheral edema ( 6.1 ) Epilepsy in patients >12 years of age: Somnolence, dizziness, ataxia, fatigue, and nystagmus ( 6.1 ) Epilepsy in patients 3 to 12 years of age: Viral infection, fever, nausea and/or vomiting, somnolence, and hostility ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc., at 1-844-874-7464 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. Postherpetic Neuralgia The most common adverse reactions associated with the use of gabapentin in adults, not seen at an equivalent frequency among placebo-treated patients, were dizziness, somnolence, and peripheral edema. In the 2 controlled trials in postherpetic neuralgia, 16% of the 336 patients who received gabapentin and 9% of the 227 patients who received placebo discontinued treatment because of an adverse reaction.

The adverse reactions that most frequently led to withdrawal in gabapentin-treated patients were dizziness, somnolence, and nausea. Table 3 lists adverse reactions that occurred in at least 1% of gabapentin-treated patients with postherpetic neuralgia participating in placebo-controlled trials and that were numerically more frequent in the gabapentin group than in the placebo group. TABLE 3.

Adverse Reactions in Pooled Placebo-Controlled Trials in Postherpetic Neuralgia a Reported as blurred vision Gabapentin N=336 % Placebo N=227 % Body as a Whole Asthenia 6 5 Infection 5 4 Accidental injury 3 1 Digestive System Diarrhea 6 3 Dry mouth 5 1 Constipation 4 2 Nausea 4 3 Vomiting 3 2 Metabolic and Nutritional Disorders Peripheral edema 8 2 Weight gain 2 0 Hyperglycemia 1 0 Nervous System Dizziness 28 8 Somnolence 21 5 Ataxia 3 0 Abnormal thinking 3 0 Abnormal gait 2 0 Incoordination 2 0 Respiratory System Pharyngitis 1 0 Special Senses Amblyopia a 3 1 Conjunctivitis 1 0 Diplopia 1 0 Otitis media 1 0 Other reactions in more than 1% of patients but equally or more frequent in the placebo group included pain, tremor, neuralgia, back pain, dyspepsia, dyspnea, and flu syndrome.

There were no clinically important differences between men and women in the types and incidence of adverse reactions. Because there were few patients whose race was reported as other than white, there are insufficient data to support a statement regarding the distribution of adverse reactions by race. Epilepsy with Partial Onset Seizures (Adjunctive Therapy) The most common adverse reactions with gabapentin in combination with other antiepileptic drugs in patients >12 years of age, not seen at an equivalent frequency among placebo-treated patients, were somnolence, dizziness, ataxia, fatigue, and nystagmus.

The most common adverse reactions with gabapentin in combination with other antiepileptic drugs in pediatric patients 3 to 12 years…

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS Concentrations increased by morphine; may need dose adjustment ( 5.4 , 7.1 )

7.1Opioids Respiratory depression and sedation, sometimes resulting in death, have been reported following coadministration of gabapentin with opioids (e.g., morphine, hydrocodone, oxycodone, buprenorphine) [see Warnings and Precautions (5.8)] . Hydrocodone Coadministration of gabapentin with hydrocodone decreases hydrocodone exposure [see Clinical Pharmacology ( 12.3 )]. The potential for alteration in hydrocodone exposure and effect should be considered when gabapentin is started or discontinued in a patient taking hydrocodone.

Morphine When gabapentin is administered with morphine, patients should be observed for signs of CNS depression, such as somnolence, sedation and respiratory depression [see Clinical Pharmacology ( 12.3 )] .

7.2Other Antiepileptic Drugs Gabapentin is not appreciably metabolized nor does it interfere with the metabolism of commonly coadministered antiepileptic drugs [see Clinical Pharmacology ( 12.3 )] .

7.3Maalox ® (aluminum hydroxide, magnesium hydroxide) The mean bioavailability of gabapentin was reduced by about 20% with concomitant use of an antacid (Maalox ® ) containing magnesium and aluminum hydroxides. It is recommended that gabapentin be taken at least 2 hours following Maalox administration [see Clinical Pharmacology ( 12.3 )] .

7.4Drug/Laboratory Test Interactions Because false positive readings were reported with the Ames N-Multistix SG ® dipstick test for urinary protein when gabapentin was added to other antiepileptic drugs, the more specific sulfosalicylic acid precipitation procedure is recommended to determine the presence of urine protein.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, may cause fetal harm ( 8.1 )

8.1Pregnancy Risk Summary The totality of available data from published prospective and retrospective cohort studies pertaining to gabapentin use during pregnancy has not indicated an increased risk of major birth defects or miscarriage. There are important methodological limitations hindering interpretation of these studies [see Data] . 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 or lower than 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, whether exposure to gabapentin alone late in pregnancy may cause withdrawal signs and symptoms is not known.

The background risk of major birth defects and miscarriage for the indicated population 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 and opioids for signs and symptoms of neonatal withdrawal and manage accordingly. Data Human Data An observational study based on routinely collected data from administrative and medical registers in Denmark, Finland, Norway, and Sweden, compared the prevalence of major congenital malformations in approximately 1,500 pregnancies exposed to gabapentin monotherapy in the first trimester to pregnancies unexposed to antiepileptics (n=2,995,816) and pregnancies exposed to lamotrigine monotherapy in the first trimester (n=7,582).

The adjusted prevalence ratios in a pooled analysis were 1.00 (95% CI: 0.80-1.24) compared to pregnancies unexposed to antiepileptics and 1.29 (95% CI: 1.00-1.67) compared to pregnancies exposed to lamotrigine monotherapy in the first trimester. Data from another observational study in the US based on Medicaid data, which compared the risk for major congenital malformations in more than 4,600 pregnancies exposed to gabapentin during the first trimester to unexposed pregnancies (n=1,753,865), estimated an adjusted relative risk of 1.07 (95% CI: 0.94-1.21).

Data from a cohort study of over 200,000 Medicaid-eligible pregnancies with prescription opioid exposure in the last 45 days of pregnancy found that the risk of neonatal drug withdrawal was greater in pregnancies with combined exposure to gabapentin and opioids compared to pregnancies with exposure to opioids alone. The data from these observational studies should be interpreted with caution due to the potential for exposure misclassification, outcome misclassification, and residual confounding, including by underlying disease.

Animal Data When pregnant mice received oral doses of gabapentin (500, 1,000, or 3,000 mg/kg/day) during the period of organogenesis, embryo…

🆘 Overdosage 74 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 have included 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 CNS depressants. Gabapentin can be removed by hemodialysis. If overexposure occurs, call your poison control center at 1-800-222-1222.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The precise mechanisms by which gabapentin produces its analgesic and antiepileptic actions are unknown. Gabapentin is structurally related to the neurotransmitter gamma-aminobutyric acid (GABA) but has no effect on GABA binding, uptake, or degradation. In vitro studies have shown that gabapentin binds with high-affinity to the α2δ subunit of voltage-activated calcium channels; however, the relationship of this binding to the therapeutic effects of gabapentin is unknown.

12.3Pharmacokinetics All pharmacological actions following gabapentin administration are due to the activity of the parent compound; gabapentin is not appreciably metabolized in humans. Oral Bioavailability Gabapentin bioavailability is not dose proportional; i.e., as dose is increased, bioavailability decreases. Bioavailability of gabapentin is approximately 60%, 47%, 34%, 33%, and 27% following 900, 1,200, 2,400, 3,600, and 4,800 mg/day given in 3 divided doses, respectively.

Food has only a slight effect on the rate and extent of absorption of gabapentin (14% increase in AUC and C max ). Distribution Less than 3% of gabapentin circulates bound to plasma protein. The apparent volume of distribution of gabapentin after 150 mg intravenous administration is 58±6 L (mean ±SD).

In patients with epilepsy, steady-state predose (C min ) concentrations of gabapentin in cerebrospinal fluid were approximately 20% of the corresponding plasma concentrations. Elimination Gabapentin is eliminated from the systemic circulation by renal excretion as unchanged drug. Gabapentin is not appreciably metabolized in humans.

Gabapentin elimination half-life is 5 to 7 hours and is unaltered by dose or following multiple dosing. Gabapentin elimination rate constant, plasma clearance, and renal clearance are directly proportional to creatinine clearance. In elderly patients, and in patients with impaired renal function, gabapentin plasma clearance is reduced.

Gabapentin can be removed from plasma by hemodialysis. Specific Populations Age The effect of age was studied in subjects 20 to 80 years of age. Apparent oral clearance (CL/F) of gabapentin decreased as age increased, from about 225 mL/min in those under 30 years of age to about 125 mL/min in those over 70 years of age.

Renal clearance (CLr) and CLr adjusted for body surface area also declined with age; however, the decline in the renal clearance of gabapentin with age can largely be explained by the decline in renal function. [see Dosage and Administration ( 2.4 ) and Use in Specific Populations ( 8.5 )] . Gender Although no formal study has been conducted to compare the pharmacokinetics of gabapentin in men and women, it appears that the pharmacokinetic parameters for males and females are similar and there are no significant gender differences.

Race Pharmacokinetic differences due to race have not been studied. Because gabapentin is primarily renally excreted and there are no important racial differences in creatinine clearance, pharmacokinetic differences due to race are not expected. Pediatric Gabapentin pharmacokinetics were determined in 48 pediatric subjects between the ages of 1 month and 12 years following a dose of approximately 10 mg/kg.

Peak plasma concentrations were similar across the entire age group and occurred 2 to 3 hours postdose. In general, pediatric subjects between 1 month and <5 years of age achieved approximately 30% lower exposure (AUC) than that observed in those 5 years of age and older. Accordingly, oral clearance normalized per body weight was higher in the younger children.

Apparent oral clearance of gabapentin was directly proportional to creatinine clearance. Gabapentin elimination half-life averaged 4.7 hours and was similar across the age groups studied. A population pharmacokinetic analysis was performed in 253 pediatric subjects between 1 month and 13 years of age.

Patients received 10 to 65 mg/kg/day given three times a day. Apparent oral cl…

📦 How Supplied / Storage and Handling 124 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Gabapentin tablets, USP 600 mg are available as white elliptical film-coated functionally scored tablets debossed with "7" and "5" on one side. NDC 71335-3060-1: 30 Tablets in a BOTTLE NDC 71335-3060-2: 60 Tablets in a BOTTLE NDC 71335-3060-3: 180 Tablets in a BOTTLE NDC 71335-3060-4: 90 Tablets in a BOTTLE NDC 71335-3060-5: 100 Tablets in a BOTTLE NDC 71335-3060-6: 120 Tablets in a BOTTLE NDC 71335-3060-7: 500 Tablets in a BOTTLE NDC 71335-3060-8: 84 Tablets in a BOTTLE NDC 71335-3060-9: 112 Tablets in a BOTTLE NDC 71335-3060-0: 28 Tablets in a BOTTLE Storage Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Repackaged/Relabeled by: Bryant Ranch Prepack Burbank, CA 91504

📋 Description 133 words ▾

11 DESCRIPTION The active ingredient in Gabapentin tablets, USP is gabapentin, which has the chemical name 1-(aminomethyl) cyclohexaneacetic acid. The molecular formula of gabapentin is C 9 H 17 NO 2 and the molecular weight is 171.24. The structural formula of gabapentin is: Gabapentin is a white to off-white crystalline solid with a pK a1 of 3.7 and a pK a2 of 10.7.

It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each gabapentin tablet, USP contains 600 mg or 800 mg of gabapentin, USP and the following inactive ingredients: Corn starch, copovidone, poloxamer, and magnesium stearate.

The film coating Opadry White contains hydroxypropyl cellulose and talc. FDA approved dissolution test specifications differ from USP.

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Administration Information Inform patients that gabapentin is taken orally with or without food. Inform patients that, should they divide the scored 600 mg or 800 mg tablet in order to administer a half-tablet, they should take the unused half-tablet as the next dose.

Advise patients to discard half-tablets not used within 28 days of dividing the scored tablet. Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity Prior to initiation of treatment with gabapentin, instruct patients that a rash or other signs or symptoms of hypersensitivity (such as fever or lymphadenopathy) may herald a serious medical event and that the patient should report any such occurrence to a healthcare provider immediately [see Warnings and Precautions ( 5.1 )] . Anaphylaxis and Angioedema Advise patients to discontinue gabapentin and seek medical care if they develop signs or symptoms of anaphylaxis or angioedema [ see Warnings and Precautions ( 5.2 )] .

Dizziness and Somnolence and Effects on Driving and Operating Heavy Machinery Advise patients that gabapentin may cause dizziness, somnolence, and other symptoms and signs of CNS depression. Other drugs with sedative properties may increase these symptoms. Accordingly, although patients' ability to determine their level of impairment can be unreliable, advise them neither to drive a car nor to operate other complex machinery until they have gained sufficient experience on gabapentin to gauge whether or not it affects their mental and/or motor performance adversely.

Inform patients that it is not known how long this effect lasts [see Warnings and Precautions ( 5.3 ) and Warnings and Precautions ( 5.4 )] . Suicidal Thinking and Behavior Counsel the patient, their caregivers, and families that AEDs, including gabapentin, may increase the risk of suicidal thoughts and behavior. Advise patients 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 to report behaviors of concern immediately to healthcare providers [see Warnings and Precautions (5.5)] . Also, inform patients who plan to or have discontinued gabapentin tablets, that suicidal thoughts and behavior can appear even after the drug is stopped. Respiratory Depression Inform patients about the risk of respiratory depression.

Include information that the risk is greatest for those using concomitant CNS depressants (such as opioid analgesics) or 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 (5.8)] . Use in Pregnancy Instruct patients to notify their healthcare provider if they are pregnant or intend to become pregnant during therapy, and to notify their healthcare provider if they are breast feeding or intend to breast feed during therapy [see Use in Specific Populations ( 8.1 ) and ( 8.2 )] .

The brand names listed are trademarks of their respective owners and are not trademarks of the Rising Pharma Holdings, Inc. Manufactured by: Graviti Pharmaceuticals Pvt Ltd. Telangana-502307, INDIA.

M.L. No.: 12/SRD/TS/2017/F/G Manufactured for: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Revised: 06/2025 PIR11750-04 Dispense with Medication Guide available at: https://www.risingpharma.com/Medguides/GabapentinTabletsUSPMG.pdf

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Gabapentin (GA ba PEN tin) Tablets Dispense with Medication Guide available at: https://www.risingpharma.com/Medguides/GabapentinTabletsUSPMG.pdf What is the most important information I should know about gabapentin tablets? Do not stop taking gabapentin tablets without first talking to your healthcare provider. Stopping gabapentin tablets suddenly can cause serious problems.

Gabapentin tablets can cause serious side effects including: 1. Suicidal Thoughts. Like other antiepileptic drugs, gabapentin tablets may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.

This can happen while you take gabapentin tablets as well as after stopping gabapentin tablets. 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 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.

Do not stop taking gabapentin tablets without first talking to a healthcare provider. Stopping gabapentin tablets suddenly can cause serious problems. Stopping a seizure medicine suddenly in a person who has epilepsy can cause seizures that will not stop (status epilepticus).

Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes. 2.

Changes in behavior and thinking - Using gabapentin tablets in children 3 to 12 years of age can cause emotional changes, aggressive behavior, problems with concentration, changes in school performance, restlessness, and hyperactivity. 3. Gabapentin tablets may cause serious or life-threatening allergic reactions that may affect your skin or other parts of your body such as your liver or blood cells.

This may cause you to be hospitalized or to stop gabapentin tablets. You may or may not have a rash with an allergic reaction caused by gabapentin tablets. Call a healthcare provider right away if you have any of the following symptoms: skin rash hives difficulty breathing fever swollen glands that do not go away swelling of your face, lips, throat, or tongue yellowing of your skin or of the whites of the eyes unusual bruising or bleeding severe fatigue or weakness unexpected muscle pain frequent infections These symptoms may be the first signs of a serious reaction.

A healthcare provider should examine you to decide if you should continue taking gabapentin tablets. 4. Serious breathing problems.

Serious breathing problems can happen when gabapentin tablets are taken with other medicines (such as opioid pain medicines) that can cause severe sleepiness or decreased awareness, or when it is taken by someone who already has breathing problems. Call your healthcare provider or get medical help right away if you have any of the following symptoms: ● feel short of breath ● feel very tired ● dizziness ● breathing slower than normal ● confusion ● headache Be sure that your caregiver or family members know which symptoms may be serious so they can call your healthcare provider or get medical help if you are unable to seek treatment on your own.

Your healthcare provider may lower your dose or stop your treatment with gabapentin tablets if you have serious breathing problems. What are gabapentin tablets? Gabapentin tablets are a prescription medicine used to treat: pain from damaged ne…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 71335-3059-01 · Bryant 71335-3061-01 · Bryant →
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.