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Gabapentin 100 mg Capsule, 60-count

by Bryant Ranch Prepack · 60 CAPSULE in 1 BOTTLE (71335-2053-4)

NDC 71335-2053-04

🏷️ FDA NDC (as labeled) 71335-2053-4 billing pads the package segment with a zero

This package

Contains60-count Pack sizes6 compare ↓

Also priced by: Part D plans $0.1402/unit — full pricing hub ↓

Also comes in: 28 capsules 71335-2053-02 30 capsules 71335-2053-03 84 capsules 71335-2053-06 90 capsules 71335-2053-01 120 capsules 71335-2053-05

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 Dr. Brian Staiger, PharmD

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 · 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) 71335-2053-4

Product NDC 71335-2053

11-digit billing NDC 71335205304

NCPDP billing unit EA — each (per item)

RxCUI 310430

UNII 6CW7F3G59X

Application # ANDA090858

SPL Set ID a1006139-7dfc-4d87-a5a9-aeb380c32d24

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 2011-01-29

Route ORAL

Dosage form CAPSULE

Substance GABAPENTIN

GCN Seq No 021413

GCN 00780

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 100 MG CAPSULE

FDB brand name Gabapentin

Legend status F — Federal legend — prescription drug or device

TE code (Orange Book) AB · RLD · RS

Why two NDCs? The FDA registers this code as 71335-2053-4 — 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 → 71335-2053-04. 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 holderALKEM LABORATORIES LTD

FDA applicationANDA090858 (ANDA)

Labeler code71335

First marketedJan 2011

Product typeHuman Prescription Drug

Portfolio4,433 products on file

🔎 All NDCs from Bryant Ranch Prepack

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 100 MG CAPSULE 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 →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

Some supplements/herbs that may interact with Gabapentin — tap one for details:

Activated CharcoalMajor Coffee CharcoalModerate European MandrakeModerate GlucomannanModerate Guar GumModerate Gum ArabicModerate Slippery ElmModerate TragacanthModerate

🌿 Every supplement checked against Gabapentin (106 interactions) — ranked by severity →

Nutrient depletion considerations

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

VITAMIN K Insignificant Depletion

🧪 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

Imprint216

Size14 mm

ScoringNot scored

One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.

Where does this data come from?

Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

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

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

UNII 3SY5LH9PMK
Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
UNII 2G86QN327L
Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
UNII 368GB5141J
A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
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.

6 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 system	Per each	Per 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	$0.1402	$8.41 / 60 capsules

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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Gabapentin 100 mg 00904-6665-61	Major	100 capsules	$0.021	AB	Availability likely	—
gabapentin 100 mg 16571-0867-01	Rising	100 capsules	$0.021	AB	Availability likely	—
Gabapentin 100 mg 16714-0661-01	NorthStar	100 capsules	$0.021	AB	Availability likely	—
Gabapentin 100 mg 23155-0866-01	Heritage	100 capsules	$0.021	AB	Availability likely	—
Gabapentin 100 mg 31722-0148-01	Camber	100 capsules	$0.021	AB	Availability likely	—
Gabapentin 100 mg 42385-0972-01	Laurus	100 capsules	$0.021	AB	Availability likely	—
Gabapentin 100 mg 45963-0555-11	Actavis	100 capsules	$0.021	AB	Availability likely	—
Gabapentin 100 mg 49483-0605-01	TIME	100 capsules	$0.021	AB	Availability likely	—
Gabapentin 100 mg 50228-0179-01	ScieGen	100 capsules	$0.021	AB	Availability likely	—
Gabapentin 100 mg 60687-0580-01	American	100 capsules	$0.021	AB	Availability likely	—
Gabapentin 100 mg 64380-0753-01	Strides	100 capsules	$0.021	AB	Availability likely	—
Gabapentin 100 mg 65862-0198-01	Aurobindo	100 capsules	$0.021	AB	Availability likely	—
Gabapentin 100 mg 67877-0222-01	Ascend	100 capsules	$0.021	AB	Availability likely	—
Gabapentin 100 mg 69097-0813-07	Cipla	100 capsules	$0.021	AB	Availability likely	—
Gabapentin 100 mg 69292-0640-01	Amici	100 capsules	$0.021	AB	Availability likely	—
Gabapentin 100 mg 69367-0131-06	Westminster	500 capsules	$0.021	AB	Availability likely	—
Gabapentin 100 mg 69367-0343-05	Westminster	500 capsules	$0.021	AB	Availability likely	—
Gabapentin 100 mg 70010-0926-01	Granules	100 capsules	$0.021	AB	Availability likely	—
Gabapentin 100 mg 71093-0120-04	ACI	100 capsules	$0.021	AB	Availability likely	—
Gabapentin 100 mg 83301-0003-01	Mullan	100 capsules	$0.021	AB	Availability likely	—
Gabapentin 100 mg 70010-0108-01	Granules	100 capsules	$0.021	AB	Discontinued	—
Gabapentin 100 mg 63739-0902-10	McKesson	100 capsules	$0.025	AB	FDA listed	—
Gabapentin 100 mg 64380-0867-06	Strides	100 capsules	$0.025	AB	FDA listed	—
Neurontin 100 mg 00071-0803-24	Parke-Davis	100 capsules	$2.958	AB	Discontinued	—
Neurontin 100 mg 58151-0281-01	Viatris	100 capsules	$2.958	AB	Availability likely	—
Gabapentin 100 mg 00480-3494-77	Teva	38668 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 00904-7613-61	Major	100 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 25000-0103-01	MARKSANS	4000 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 42582-0114-10	Bi-Coastal	100 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 42806-0509-01	Epic	100 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 43547-0479-10	Solco	100 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 45865-0216-30	Medsource	30 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 50090-0949-00	A-S	30 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 50090-3200-00	A-S	30 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 50090-6875-00	A-S	90 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 50090-7169-00	A-S	90 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 50090-7388-00	A-S	30 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 50090-7389-00	A-S	90 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 50090-7672-00	A-S	30 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 50090-7673-00	A-S	90 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 51407-0047-10	Golden	1000 capsules	—	AB	Discontinued	—
Gabapentin 100 mg 53746-0101-01	Amneal	100 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 55154-3363-00	Cardinal	10 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 55154-8194-00	Cardinal	10 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 55700-0950-01	Quality	120 capsules	—	AB	Discontinued	—
Gabapentin 100 mg 58118-2101-08	Clinical	30 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 60760-0669-30	St.	30 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 60760-0740-60	St.	60 capsules	—	AB	Discontinued	—
Gabapentin 100 mg 60760-0818-60	St.	60 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 60760-0926-30	ST.	30 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 60760-0939-60	St.	60 capsules	—	AB	FDA listed	—
gabapentin 100 mg 62756-0137-01	Sun	50 capsules	—	—	FDA listed	—
Gabapentin 100 mg 63187-0392-00	Proficient	100 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 63629-8484-01	Bryant	500 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 63629-8485-01	Bryant	100 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 65162-0101-03	Amneal	30 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 67046-1257-03	Coupler	30 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 67296-2192-03	Redpharm	30 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 68071-2600-06	NuCare	60 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 68071-3664-03	NuCare	30 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 68071-3759-01	NuCare	100 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 68071-4978-09	NuCare	90 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 68071-5017-01	NuCare	100 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 68788-4107-01	Preferred	100 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 68788-8194-01	Preferred	100 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 68788-8199-01	Preferred	100 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 68788-8489-01	Preferred	100 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 68788-8563-01	Preferred	100 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 69434-0042-03	Zhejiang	500 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 70518-1834-00	REMEDYREPACK	30 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 70518-2614-00	REMEDYREPACK	90 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 70518-3330-00	REMEDYREPACK	100 capsules	—	AB	Discontinued	—
Gabapentin 100 mg 70518-4261-00	REMEDYREPACK	30 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 70518-4493-00	REMEDYREPACK	100 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 71205-0317-30	Proficient	30 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 71205-0373-15	Proficient	15 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 71205-0638-30	Proficient	30 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 71205-0661-15	Proficient	15 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 71205-0928-00	Proficient	100 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 71335-0073-00	Bryant	65 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 71335-1169-00	Bryant	65 capsules	—	AB	Discontinued	—
Gabapentin 100 mg 71335-1198-00	Bryant	65 capsules	—	AB	Discontinued	—
Gabapentin 100 mg 71335-1375-01	Bryant	90 capsules	—	AB	Discontinued	—
Gabapentin 100 mg 71335-1484-01	Bryant	90 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 71335-1655-00	Bryant	65 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 71335-1991-00	Bryant	65 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 71335-2005-01	Bryant	90 capsules	—	AB	FDA listed	—
Gabapentin 100 mgthis 71335-2053-04	Bryant	60 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 71335-2279-01	Bryant	1000 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 71335-2741-01	Bryant	90 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 71335-3140-01	Bryant	90 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 71610-0072-60	Aphena	90 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 71610-0126-60	Aphena	90 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 71610-0421-30	Aphena	30 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 71610-0667-30	Aphena	30 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 71610-0756-30	Aphena	30 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 72162-1532-01	Bryant	100 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 72162-2138-01	Bryant	100 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 72189-0109-30	DIRECT	30 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 72189-0384-90	Direct_Rx	90 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 72189-0419-30	Direct_Rx	30 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 72189-0460-60	Direct_Rx	60 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 72737-0005-01	STALLION	30 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 72789-0123-30	PD-Rx	30 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 72789-0289-30	PD-Rx	30 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 72865-0252-05	XLCare	500 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 76282-0321-01	Exelan	100 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 76420-0014-30	Asclemed	30 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 76420-0259-01	Asclemed	100 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 76420-0868-00	Asclemed	1000 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 80425-0128-02	Advanced	60 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 80425-0150-02	Advanced	60 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 80425-0199-01	Advanced	30 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 82619-0142-01	Creekwood	100 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 82804-0178-90	Proficient	90 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 82804-0226-30	Proficient	30 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 82868-0074-30	Northwind	30 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 87441-0034-01	Unit	30 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 85534-0055-00	HAWAII	30 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 87063-0687-12	ASCLEMED	120 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 85534-0003-00	HAWAII	30 capsules	—	AB	FDA listed	—
gabapentin 100 mg 70518-4706-00	REMEDYREPACK	30 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 82868-0108-30	Northwind	30 capsules	—	AB	FDA listed	—
Gabapentin 100 mg 70518-4742-00	REMEDYREPACK	100 capsules	—	AB	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

🏛️

2011

On the market since

Jan 2011

📍

2026

Currently FDA-listed

15 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

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

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 NDC	Description	Marketing start	Status
71335-2053-01	90 CAPSULE in 1 BOTTLE (71335-2053-1)	2022-03-07	Active
71335-2053-02	28 CAPSULE in 1 BOTTLE (71335-2053-2)	2022-09-16	Active
71335-2053-03	30 CAPSULE in 1 BOTTLE (71335-2053-3)	2022-02-24	Active
71335-2053-04 You're viewing this	60 CAPSULE in 1 BOTTLE (71335-2053-4)	2022-04-18	Active
71335-2053-05	120 CAPSULE in 1 BOTTLE (71335-2053-5)	2022-09-16	Active
71335-2053-06	84 CAPSULE in 1 BOTTLE (71335-2053-6)	2022-06-16	Active

You're viewing one of 6 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 71335-2053-04?

NDC 71335-2053-04 is a 60-count package — 60 capsule in 1 bottle.

What is the difference between NDC 71335-2053-04 and NDC 71335-2053-02?

Both are Gabapentin 100 mg Capsule — the drug itself is identical. NDC 71335-2053-04 is the 60-count package, while NDC 71335-2053-02 is the 28 capsules package.

What NDC number is used to bill for this package of Gabapentin 100 mg Capsule?

Bill NDC 71335-2053-04 — the 11-digit billing format is 71335205304. 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

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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
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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 71335-2053-4, 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: 71335-2053-04, written without dashes as 71335205304. 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 71335-2053-04, the first segment (71335) is the labeler code FDA assigned to Bryant Ranch Prepack; the middle segment (2053) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) 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 5 other package presentations of this same product, including 28 capsules (71335-2053-02), 30 capsules (71335-2053-03), 84 capsules (71335-2053-06). 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 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide

🎯 Indications and Usage 82 words ▾

1 INDICATIONS AND USAGE 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 Gabapentin is 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 1800 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 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 2400 mg/day have been administered in long-term clinical studies.

Doses of 3600 mg/day have also been administered to a small number of patients for a relatively short duration. Administer gabapentin three times a day using 300 mg or 400 mg capsules. 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 the oral capsule. 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 Renal Function Creatinine Clearance (mL/min) Total Daily Dose Range (mg/day) Dose Regimen (mg) ≥ 60 900 to 3600 300 TID 400 TID 600 TID 800 TID 1200 TID > 30 to 59 400 to 1400 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 p…

💊 Dosage Forms and Strengths 56 words ▾

3 DOSAGE FORMS AND STRENGTHS Capsules 100 mg: White hard gelatin capsules imprinted “216” on body with blue ink. 300 mg: Yellow hard gelatin capsules imprinted “215” on body with blue ink. 400 mg: Orange hard gelatin capsules imprinted “214” on body with blue ink. Capsules: 100 mg, 300 mg, and 400 mg ( 3 )

⛔ Contraindications 24 words ▾

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

⚠️ 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 ) • Increased seizure frequency may occur in patients with seizure disorders if gabapentin is abruptly discontinued ( 5.5 ) • Suicidal Behavior and Ideation: Monitor for suicidal thoughts/behavior ( 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 ( 5.7 ) • Neuropsychiatric Adverse Reactions in Children 3 to 12 Years of Age: Monitor for such events ( 5.8 )

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 1800 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…

🤒 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 )] · Withdrawal Precipitated Seizure, Status Epilepticus [see Warnings and Precautions (5.5 )] · Suicidal Behavior and Ideation [see Warnings and Precautions (5.6 )] Respiratory Depression [see Warnings and Precautions ( 5.7 )] · Neuropsychiatric Adverse Reactions (Pediatric Patients 3 to 12 Years of Age) [see Warnings and Precautions ( 5.8 ) ] · Sudden and Unexplained Death in Patients with Epilepsy [ see Warnings and Precautions ( 5.10 ) ] 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 Ascend Laboratories, LLC at 1-877-272-7901 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 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 a Reported as blurred vision 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 pat…

🔄 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 (5.7)]. 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 USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, may cause fetal harm (8.1)

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 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]. 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. 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).

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, 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 on a body surface area (mg/m 2 ) basis.

In studies in which rats received oral doses of gabapentin (500 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, 300, 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 synap…

🤰 Pregnancy ~3 min read ▾

🧒 Pediatric Use 51 words ▾

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 )].

🧓 Geriatric Use ~1 min read ▾

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 effect observed in patients ≥ 75 years may be a consequence of increased gabapentin exposure for a given dose that results from an age-related decrease in renal function.

However, other factors cannot be excluded. The types and incidence of adverse reactions were similar across age groups except for peripheral edema and ataxia, which tended to increase in incidence with age. Clinical studies of gabapentin in epilepsy did not include sufficient numbers of subjects aged 65 and over to determine whether they responded differently from younger subjects.

Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function.

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 [see Dosage and Administration (2.4 ), Adverse Reactions (6 ), and Clinical Pharmacology (12.3 )] .

🆘 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, 1200, 2400, 3600, and 4800 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 clearance…

🧬 Mechanism of Action 70 words ▾

📦 How Supplied / Storage and Handling 86 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Gabapentin Capsules USP 100 mg capsules: White hard gelatin capsules imprinted “216” on body with blue ink. NDC 71335-2053-1: 90 Capsules in a BOTTLE NDC 71335-2053-2: 28 Capsules in a BOTTLE NDC 71335-2053-3: 30 Capsules in a BOTTLE NDC 71335-2053-4: 60 Capsules in a BOTTLE NDC 71335-2053-5: 120 Capsules in a BOTTLE NDC 71335-2053-6: 84 Capsules in a BOTTLE Storage Store at 20° to 25°C (68° to 77°F); [see USP Controlled Room Temperature]. Repackaged/Relabeled by: Bryant Ranch Prepack Burbank, CA 91504

📋 Description 177 words ▾

11 DESCRIPTION The active ingredient in gabapentin capsules 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 pKa1 of 3.7 and a pKa2 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 capsule contains 100 mg, 300 mg, or 400 mg of gabapentin and the following inactive ingredients: anhydrous lactose, cornstarch, and talc.

The 100 mg capsule shell contains gelatin, sodium lauryl sulfate, and titanium dioxide. The 300 mg capsule shell contains gelatin, sodium lauryl sulfate, titanium dioxide, and yellow iron oxide. The 400 mg capsule shell contains gelatin, sodium lauryl sulfate, red iron oxide, titanium dioxide, and yellow iron oxide.

The imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propyl glycol, strong ammonia solution, and titanium dioxide.

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Administration Information 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 physician 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 (5.6 )] . 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 (5.7)] . Use in Pregnancy Instruct patients to notify their physician if they become pregnant or intend to become pregnant during therapy, and to notify their physician if they are breast feeding or intend to breast feed during therapy [see Use in Specific Populations (8.1) and ( 8.2 )] .

Encourage patients to enroll in the NAAED Pregnancy Registry if they become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll-free number 1-888-233-2334 [see Use in Specific Populations (8.1 )] .

Manufactured by: Alkem Laboratories Ltd., INDIA. Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 Revised: October, 2024 PT 1702-12 Trademarks are the property of their respective owners.

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Gabapentin Capsules USP (GA ba PEN tin) What is the most important information I should know about gabapentin? Do not stop taking gabapentin without first talking to your healthcare provider. Stopping gabapentin suddenly can cause serious problems.

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

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 without first talking to a healthcare provider. Stopping gabapentin 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 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 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. You may or may not have a rash with an allergic reaction caused by gabapentin.

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. 4.

Serious breathing problems. Serious breathing problems can happen when gabapentin is 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 if you have serious breathing problems. What is gabapentin? Gabapentin is a prescription medicine used to treat: pain from damaged nerves (postherpetic pain) that follows healing of shingles (a painful rash that comes after a herpes zoster infection) in adults. partial seizures when taken together with other medicines in adults and children 3 years of age and older with seizures.

It is not known if gabapentin is safe and effective to treat: children with pain from damaged ne…

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

in vitro: In a laboratory dish or test tube rather than in a living person or animal; results may not carry over to people.

sedative: A substance with a calming effect that can also cause drowsiness.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

Active ingredient: The part of a medicine that produces its intended effect on the body.

adjunctive therapy: A medicine added alongside a main treatment to help it work better.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

anaphylaxis: A sudden, severe, whole-body allergic reaction that can cause trouble breathing, swelling, and a drop in blood pressure, needing emergency care.

angioedema: Rapid swelling deep under the skin, often around the eyes, lips, tongue, or throat.

anxiety: A feeling of worry, nervousness, or unease, sometimes along with a racing heart or restlessness.

asthenia: Unusual weakness or lack of physical strength and energy.

ataxia: Loss of muscle coordination that makes walking, balance, and controlled movements clumsy or unsteady.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

Bioavailability: The share of a dose that actually reaches the bloodstream and is able to have an effect.

clearance: How quickly the body removes a medicine from the blood, usually through the liver and kidneys.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

CNS depression: A slowing of brain and nervous-system activity that can cause drowsiness, slowed breathing, or reduced alertness.

conjunctivitis: Redness and irritation of the thin lining over the white of the eye, often called pink eye.

constipation: Having bowel movements less often than usual, or passing stools that are hard, dry, and difficult to move.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

creatinine clearance: An estimate of how fast the kidneys filter waste from the blood, often used to choose the right medicine dose.

depression: A lasting low mood with loss of interest that affects everyday life.

diarrhea: Loose, watery bowel movements that happen more often than normal.

diplopia: Double vision, or seeing two images of a single object.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

dyspepsia: Discomfort, fullness, or a burning feeling in the upper belly, commonly called indigestion.

dyspnea: The medical word for shortness of breath, or the feeling that you cannot get enough air.

edema: Swelling caused by extra fluid trapped in the body's tissues.

efficacy: How well a treatment works under the controlled conditions of a clinical study.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

eosinophilia: A higher-than-normal level of eosinophils, a type of white blood cell often linked to allergies or drug reactions.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

Excretion: How the body removes a medicine or its leftover pieces, mainly through the urine or stool.

extended-release: A pill or capsule made to release its medicine slowly over many hours, so it can be taken less often; often labeled ER or XR.

fetal harm: Injury or damage to a developing baby while it is growing inside the womb.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

hemodialysis: A treatment that uses a machine to filter waste and extra fluid from the blood when the kidneys cannot.

hepatitis: Inflammation of the liver, which can be caused by infections, alcohol, or certain medicines.

herpes zoster: The medical name for shingles, a painful rash caused by reactivation of the virus that causes chickenpox.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hyperglycemia: High blood sugar, meaning there is more glucose (sugar) in the blood than normal.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypotension: Blood pressure that is lower than normal, which can cause dizziness or fainting.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

insomnia: Trouble falling asleep, staying asleep, or getting restful sleep.

intravenous: Given directly into a vein through a needle or thin tube; often written as IV.

irritability: Getting annoyed, frustrated, or angry more easily than usual.

lethargy: A state of tiredness and sluggishness, often with slowed thinking or movement.

lymphadenopathy: Swollen or enlarged lymph nodes, often felt as lumps in the neck, armpits, or groin.

maintenance dose: The regular ongoing dose taken to keep a steady, effective amount of medicine in the body over time.

mania: A period of unusually high energy, racing thoughts, and an excited or irritable mood that is more extreme than normal.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Medication Guide: An FDA-approved handout written for patients that explains important safety information about certain medicines in plain language.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

monotherapy: Treatment using a single medicine by itself.

myositis: Swelling and irritation of muscle tissue that can cause pain, tenderness, or weakness.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

neonatal: Relating to a newborn baby during its first four weeks of life.

nystagmus: Rapid, involuntary back-and-forth movements of the eyes that a person cannot control.

organogenesis: The early stage of pregnancy when the developing baby's organs are first forming.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

peripheral edema: Swelling, usually in the feet, ankles, or legs, caused by extra fluid building up in the tissues.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

placebo: An inactive treatment with no real medicine in it, such as a sugar pill, used for comparison in a study.

placebo-controlled: Describes a study that compares people taking the real medicine against people taking a dummy pill with no active ingredient.

pooled analysis: Combining the results of several separate studies into one larger group to look at the overall pattern.

Pregnancy Exposure Registry: A study that collects health information from women who took a medicine while pregnant to learn how safe it is.

prodrug: A medicine that is inactive when taken and must be changed by the body into its working form.

relative risk: A number comparing the chance of an event in one group with the chance of that same event in another group.

renal excretion: Removal of a medicine from the body through the kidneys into the urine.

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

respiratory depression: Breathing that becomes too slow or too shallow to move enough air, so the body may not get enough oxygen.

restlessness: An inability to stay calm or still, with a constant feeling of needing to move.

sedation: A calm, sleepy, slowed-down state caused by a medicine that relaxes the brain and body.

seizure: A sudden burst of abnormal electrical activity in the brain that can cause shaking, staring, confusion, or loss of awareness.

somnolence: Feeling very sleepy or drowsy, with trouble staying awake during the day.

status epilepticus: A seizure that lasts a long time, or repeated seizures without recovery in between, which is a medical emergency.

suicidal behavior: Actions a person takes to try to end their own life, or steps taken in preparation for it.

systemic circulation: The main bloodstream that carries a medicine throughout the whole body.

titration: Slowly adjusting a medicine's dose up or down in small steps to find the amount that works best with the fewest side effects.

tremor: Shaking or trembling of part of the body, such as the hands, that a person cannot control.

trimester: One of the three roughly three-month stages that a pregnancy is divided into.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

volume of distribution: A calculated value showing how widely a medicine spreads into body tissues versus staying in the blood.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

withdrawal: Uncomfortable physical or mental symptoms that appear when a medicine the body has gotten used to is reduced or stopped.

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.

Gabapentin 100 mg Capsule, 60-count

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