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Gabapentin 600 mg Tablet, 90-count — NDC 72189-0313-90 package photo

Gabapentin 600 mg Tablet, 90-count

by Directrx · 90 TABLET in 1 BOTTLE (72189-313-90)
NDC 72189-0313-90
🏷️ FDA NDC (as labeled) 72189-313-90 billing pads the product segment with a zero
This package
Contains90-count Pack sizes3 compare ↓
Also priced by: Part D plans $0.1683/unit — full pricing hub ↓
Also comes in: 60 tablets 72189-0313-60 120 tablets 72189-0313-72
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) 72189-313-90
Product NDC 72189-313
11-digit billing NDC 72189031390
NCPDP billing unit EA — each (per item)
RxCUI 310433
UNII 6CW7F3G59X
Application # ANDA205101
SPL Set ID d5c9dd2c-b8ee-1406-e053-2995a90a0287
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 2022-01-17
Route ORAL
Dosage form TABLET
Substance GABAPENTIN
GPI-14 72600030000330
GPI class 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 72189-313-90 — 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 → 72189-0313-90. 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

LabelerDirectrx
Application holderSCIEGEN PHARMACEUTICALS INC
FDA applicationANDA205101 (ANDA)
Labeler code72189
First marketedJan 2022
Product typeHuman Prescription Drug
Portfolio49 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
ShapeCapsule
ImprintSG;177
Size18 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII D9C330MD8B
    Copovidone is a synthetic polymer made by combining two types of plastic-like molecules. It acts as a binder and film-former to help hold tablet ingredients together and improve how the medicine dissolves in your body.
  • UNII 2S7830E561
    Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
  • UNII 9XZ8H6N6OH
    A plant-based cellulose derivative used as a binder to hold tablet ingredients together, a thickener in liquids, and a coating agent to control how fast the medicine dissolves.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • UNII TUF2IVW3M2
    Poloxamer 407 is a synthetic polymer made from ethylene oxide and propylene oxide. In medicines, it acts as a thickener, emulsifier, and solubilizer to help mix ingredients and create the right texture.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

11 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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 $15.15 / 90 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 mg 71335-3060-00 Bryant 28 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 mgthis 72189-0313-90 Directrx 90 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 —
Gabapentin 600 mg 85509-1166-03 PHOENIX 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

🏛️
2022
On the market since
Jan 2022
📍
2026
Currently FDA-listed
4 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
72189-0313-60 60 TABLET in 1 BOTTLE (72189-313-60) 2022-01-17 Active
72189-0313-72 120 TABLET in 1 BOTTLE (72189-313-72) 2022-01-17 Active
72189-0313-90 You're viewing this 90 TABLET in 1 BOTTLE (72189-313-90) 2022-01-17 Active

You're viewing one of 3 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 72189-0313-90?
NDC 72189-0313-90 is a 90-count package — 90 tablet in 1 bottle.
What is the difference between NDC 72189-0313-90 and NDC 72189-0313-60?
Both are Gabapentin 600 mg Tablet — the drug itself is identical. NDC 72189-0313-90 is the 90-count package, while NDC 72189-0313-60 is the 60 tablets package.
What NDC number is used to bill for this package of Gabapentin 600 mg Tablet?
Bill NDC 72189-0313-90 — the 11-digit billing format is 72189031390. 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) ✓ 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 72189-313-90, 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: 72189-0313-90, written without dashes as 72189031390. 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 72189-0313-90, the first segment (72189) is the labeler code FDA assigned to Directrx; the middle segment (0313) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (90) 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 Directrx. 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 60 tablets (72189-0313-60), 120 tablets (72189-0313-72). 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?
Directrx 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?
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📄 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 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage 35 words ▾

Gabapentin is 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

⏱️ Dosage and Administration ~3 min read ▾

2.1Dosage for Postherpetic Neuralgia In adults with postherpetic neuralgia, gabapentin 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 1800 mg/day (600 mg three times a day). In clinical studies, efficacy was demonstrated over a range of doses from 1800 mg/day to 3600 mg/day with comparable effects across the dose range; however, in these clinical studies, the additional benefit of using doses greater than 1800 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 is 300 mg to 600 mg three times a day. Dosages up to 2,400 mg/day have been well tolerated 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, and have been well tolerated. Administer gabapentin three times a day using 300 mg or 400 mg capsules, or 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 in patients 3 to 4 years of age is 40 mg/kg/day, given in three divided doses. The recommended maintenance dose of gabapentin 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 capsule, or tablet, or using combinations of these formulations. Dosages up to 50 mg/kg/day have been well tolerated 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 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 BID 300 BID 400 BID 500 BID 700 BID > 15 to 29 200 to 700 200 QD 300 QD 400 QD 500 QD 700 QD 15 a 100 to 300 100 QD 125 QD 150 QD 200 QD 300 QD Post-Hemodialysis Supplemental Dose (mg) b Hemodialysis 125 b 150 b 200 b 250 b 350 b 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.

Creatinine clearance (CLCr) is difficult to measure in outpatients. In patients with stable renal function, creatinine clearance can be reasonably well estimated using the equation of Cockcroft and Gault: [image-04] The use of gabapentin in patients less than 12 years of age with compromised renal function has not been studied.

2.4Dosage in Elderly Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and dose should be adjusted based on creatinine clearance values in these patients.

2.5Administration Information Administer gabapentin orally with or without food. Gabapentin capsules shou…

💊 Dosage Forms and Strengths 166 words ▾

Capsules: 100 mg: White to off-white powder filled in size “3” hard gelatin capsules with opaque white colored cap and opaque white colored body imprinted SG on cap and 179 on body with black ink. 300 mg: White to off-white powder filled in size “1” hard gelatin capsules with opaque yellow colored cap and opaque yellow colored body imprinted SG on cap and 180 on body with black ink. 400 mg: White to off-white powder filled in size “0” hard gelatin capsules with opaque orange colored cap and opaque orange colored body imprinted SG on cap and 181 on body with black ink.

Tablets: 600 mg: White to off white, modified capsule shape, biconvex, film-coated functional scored tablets debossed with “SG” on one side and “177” on other side with bisect line on both sides. 800 mg: White to off white, modified capsule shape, biconvex, film-coated functional scored tablets debossed with “SG” on one side and “178” on other side with bisect line on both sides.

⛔ Contraindications 15 words ▾

Gabapentin is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients.

🤒 Adverse Reactions ~3 min read ▾

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 placebo for somnolence, 17% in drug versus 7% in placebo for dizziness, and 13% in drug versus 6% in placebo for ataxia. In these trials somnolence, ataxia and fatigue were common adverse reactions leading to discontinuation of gabapentin in patients older than 12 years of age, with 1.2%, 0.8% and 0.6% discontinuing for these events, respectively.

During the controlled trials in patients with post-herpetic neuralgia, somnolence, and dizziness were reported at a greater rate compared to placebo in patients receiving gabapentin, in dosages up to 3600 mg per day: i.e., 21% in gabapentin-treated patients versus 5% in placebo-treated patients for somnolence and 28% in Gabapentin-treated patients versus 8% in placebo-treated patients for dizziness. Dizziness and somnolence were among the most common adverse reactions leading to discontinuation of gabapentin. Patients should be carefully observed for signs of central nervous system (CNS) depression, such as somnolence and sedation, when gabapentin is used with other drugs with sedative properties because of potential synergy.…

🔄 Drug Interactions 211 words ▾

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 (5.7)]. 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 ▾

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as 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 http://www.aedpregnancyregistry.org/. Risk Summary There are no adequate data on the developmental risks associated with the use of gabapentin in pregnant women.

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]. 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. The background risk of major birth defects and miscarriage for the indicated population is unknown.

Data Animal data When pregnant mice received oral doses of gabapentin (500 mg/kg/day, 1,000 mg/kg/day, or 3,000 mg/kg/day) during the period of organogenesis, embryofetal toxicity (increased incidences of skeletal variations) was observed at the two highest doses. The no-effect dose for embryofetal developmental toxicity in mice (500 mg/kg/day) is less than the maximum recommended human dose (MRHD) of 3,600 mg/kg on a body surface area (mg/m 2) basis. In studies in which rats received oral doses of gabapentin (500 mg/kg/day to 2,000 mg/kg/day) during pregnancy, adverse effect on offspring development (increased incidences of hydroureter and/or hydronephrosis) were observed at all doses.

The lowest dose tested is similar to the MRHD on a mg/m 2 basis. When pregnant rabbits were treated with gabapentin during the period of organogenesis, an increase in embryofetal mortality was observed at all doses tested (60 mg/kg, 300 mg/kg, or 1,500 mg/kg). The lowest dose tested is less than the MRHD on a mg/m 2 basis.

In a published study, gabapentin (400 mg/kg/day) was administered by intraperitoneal injection to neonatal mice during the first postnatal week, a period of synaptogenesis in rodents (corresponding to the last trimester of pregnancy in humans). Gabapentin caused a marked decrease in neuronal synapse formation in brains of intact mice and abnormal neuronal synapse formation in a mouse model of synaptic repair. Gabapentin has been shown in vitro to interfere with activity of the α2δ subunit of voltage-activated calcium channels, a receptor involved in neuronal synaptogenesis.

The clinical significance of these findings is unknown.

8.2Lactation Risk Summary Gabapentin is secreted in human milk following oral administration. The effects on the breastfed infant and on milk production are unknown. 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.

8.4Pediatric Use Safety and effectiveness of Gabapentin in the management of postherpetic neuralgia in pediatric patients have not been established. Safety and effectiveness as adjunctive therapy in the treatment of partial seizures in pediatric patients below the age of 3 years has not been established [see CLINICAL STUDIES (14.2)].

8.5Geriatric Use The total number of patients treated with gabapentin in controlled clinical trials in patients with postherpetic neuralgia was 336, of which 102 (30%) were 65 to 74 years of age, and 168 (50%) were 75 years of age and older. There was a larger treatment effect in patients 75 years of age and older compared to younger patients who received the same dosage. Since gabapentin is almost exclusively eliminated by renal excretion, the larger treatment ef…

🆘 Overdosage 72 words ▾

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 ▾

12.1Mechanism of Action The precise mechanism 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 mg/day, 1,200 mg/day, 2,400 mg/day, 3,600 mg/day, 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 mg/kg/day to 65 mg/kg/day given three times a day. Apparent or…

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

Gabapentin capsules and tablets, USP are supplied as follows: 100 mg capsules: White to off-white powder filled in size “3” hard gelatin capsules with opaque white colored cap and opaque white colored body imprinted SG on cap and 179 on body with black ink, available in: Bottles of 30: NDC 50228-179-30 Bottles of 100: NDC 50228-179-01 Bottles of 500: NDC 50228-179-05 Bottles of 1000: NDC 50228-179-10 300 mg capsules: White to off-white powder filled in size “1” hard gelatin capsules with opaque yellow colored cap and opaque yellow colored body imprinted SG on cap and 180 on body with black ink, available in: Bottles of 30: NDC 50228-180-30 Bottles of 100: NDC 50228-180-01 Bottles of 500: NDC 50228-180-05 Bottles of 1000: NDC 50228-180-10 400 mg capsules: White to off-white powder filled in size “0” hard gelatin capsules with opaque orange colored cap and opaque orange colored body imprinted SG on cap and 181 on body with black ink, available in: Bottles of 30: NDC 50228-181-30 Bottles of 100: NDC 50228-181-01 Bottles of 500: NDC 50228-181-05 600 mg tablets: White to off white, modified capsule shape, biconvex, film-coated functional scored tablets debossed with “SG” on one side and “177” on other side with bisect line on both sides, available in: Bottles of 30: NDC 50228-177-30 Bottles of 100: NDC 50228-177-01 Bottles of 500: NDC 50228-177-05 800 mg tablets: White to off white, modified capsule shape, biconvex, film-coated functional scored tablets debossed with “SG” on one side and “178” on other side with bisect line on both sides, available in: Bottles of 30: NDC 50228-178-30 Bottles of 100: NDC 50228-178-01 Bottles of 500: NDC 50228-178-05 Store gabapentin capsules and tablets at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

📋 Description ~1 min read ▾

The active ingredient in gabapentin capsules and tablets, USP is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C 9H 17NO 2 and the molecular weight is 171.24. The structural formula of gabapentin is: [Gabapentin Structural Formula] Gabapentin, USP is a white to off-white crystalline solid with a pK a1 of 4.72±0.10 and a pK a2 of 10.27±0.29.

It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient is -1.083±0.235 at 25°C temperature. Each gabapentin capsule contains 100 mg, 300 mg or 400 mg of gabapentin, USP and the following inactive ingredients: pregelatinized starch (maize), and talc.

The 100 mg capsule shell contains gelatin, sodium lauryl sulfate (SLS) and titanium dioxide. The 300 mg capsule shell contains gelatin, titanium dioxide, FD&C Red 40, D&C Yellow 10, and sodium lauryl sulfate (SLS). The 400 mg capsule shell contains gelatin, titanium dioxide, sodium lauryl sulfate (SLS), D&C Yellow 10, and FD&C Red 40.

The imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, and potassium hydroxide. Each gabapentin tablet contains 600 mg or 800 mg of gabapentin, USP and the following inactive ingredients: poloxamer 407, mannitol, magnesium stearate, hydroxypropyl cellulose, talc, copovidone, crospovidone, colloidal silicon dioxide and coating agent contains hypromellose, titanium dioxide, polyethylene glycol and talc.

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