Home › NDC Lookup › Ingredients › Gabapentin › 61919-0640-30

GABAPENTIN 300 mg Capsule, 30-count

by DIRECT RX · 30 CAPSULE in 1 BOTTLE (61919-640-30)

NDC 61919-0640-30

🏷️ FDA NDC (as labeled) 61919-640-30 billing pads the product segment with a zero

This package

Contains30-count Pack sizes5 compare ↓

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

Also comes in: 60 capsules 61919-0640-60 90 capsules 61919-0640-90 120 capsules 61919-0640-72 180 capsules 61919-0640-82

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) 61919-640-30

Product NDC 61919-640

11-digit billing NDC 61919064030

NCPDP billing unit EA — each (per item)

RxCUI 310431

UNII 6CW7F3G59X

Application # ANDA090007

SPL Set ID 29a70e2d-d3fd-4e32-95dd-7ee721d87388

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 2015-12-30

Route ORAL

Dosage form CAPSULE

Substance GABAPENTIN

GPI-14 72600030000130

GPI class Gabapentin

GCN Seq No 021414

GCN 00781

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 300 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 61919-640-30 — 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 → 61919-0640-30. 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

LabelerDIRECT RX

Application holderMARKSANS PHARMA LTD

FDA applicationANDA090007 (ANDA)

Labeler code61919

First marketedDec 2015

Product typeHuman Prescription Drug

Portfolio204 products on file

🔎 All NDCs from DIRECT RX

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 300 MG CAPSULE Ingredient Gabapentin

📗 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 yellow

ShapeCapsule

ImprintIG322;300mg

Size21 mm

ScoringNot scored

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

Where does this data come from?

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

🧪 Inactive Ingredients / Excipients

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

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.

Where does this data come from?

Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 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	$4.21 / 30 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 300 mg 63739-0903-10	McKesson	100 capsules	$0.030	AB	Availability likely	—
Gabapentin 300 mg 00480-3495-01	Teva	100 capsules	$0.031	AB	Availability likely	—
Gabapentin 300 mg 00904-6666-61	Major	100 capsules	$0.031	AB	Availability likely	—
gabapentin 300 mg 16571-0868-01	Rising	100 capsules	$0.031	AB	Availability likely	—
Gabapentin 300 mg 16714-0662-01	NorthStar	100 capsules	$0.031	AB	Availability likely	—
Gabapentin 300 mg 23155-0867-01	Heritage	100 capsules	$0.031	AB	Availability likely	—
Gabapentin 300 mg 31722-0149-01	Camber	100 capsules	$0.031	AB	Availability likely	—
Gabapentin 300 mg 42385-0973-01	Laurus	100 capsules	$0.031	AB	Availability likely	—
Gabapentin 300 mg 45963-0556-11	Actavis	100 capsules	$0.031	AB	Availability likely	—
Gabapentin 300 mg 49483-0606-01	TIME	100 capsules	$0.031	AB	Availability likely	—
Gabapentin 300 mg 50228-0180-01	ScieGen	100 capsules	$0.031	AB	Availability likely	—
Relgaabi 300 mg 58657-0233-01	Method	100 capsules	$0.031	AB	Availability likely	—
Gabapentin 300 mg 60687-0591-01	American	100 capsules	$0.031	AB	Availability likely	—
Gabapentin 300 mg 64380-0754-01	Strides	100 capsules	$0.031	AB	Availability likely	—
Gabapentin 300 mg 65862-0199-01	Aurobindo	100 capsules	$0.031	—	Availability likely	—
Gabapentin 300 mg 67877-0223-01	Ascend	100 capsules	$0.031	AB	Availability likely	—
Gabapentin 300 mg 69292-0641-01	Amici	100 capsules	$0.031	AB	Availability likely	—
Gabapentin 300 mg 69367-0132-06	Westminster	500 capsules	$0.031	AB	Availability likely	—
Gabapentin 300 mg 69367-0344-05	Westminster	500 capsules	$0.031	AB	Availability likely	—
Gabapentin 300 mg 70010-0927-01	Granules	100 capsules	$0.031	AB	Availability likely	—
Gabapentin 300 mg 71093-0121-04	ACI	100 capsules	$0.031	AB	Discontinued	—
Gabapentin 300 mg 83301-0004-01	Mullan	100 capsules	$0.031	AB	Availability likely	—
Gabapentin 300 mg 70010-0109-01	Granules	100 capsules	$0.034	AB	Discontinued	—
Gabapentin 300 mg 64380-0868-06	Strides	100 capsules	$0.041	AB	FDA listed	—
Gabapentin 300 mg 69097-0943-07	Cipla	100 capsules	$0.041	AB	FDA listed	—
Neurontin 300 mg 00071-0805-24	Parke-Davis	100 capsules	$7.371	AB	Availability likely	—
Neurontin 300 mg 58151-0282-01	Viatris	100 capsules	$7.371	AB	Availability likely	—
Gabapentin 300 mg 00904-7614-61	Major	100 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 25000-0104-03	MARKSANS	30 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 42582-0115-10	Bi-Coastal	100 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 42806-0510-01	Epic	100 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 43063-0673-30	PD-Rx	30 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 43353-0075-30	Aphena	30 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 43547-0480-10	Solco	100 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 45865-0194-30	Medsource	30 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 50090-0896-00	A-S	100 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 50090-4893-00	A-S	90 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 50090-6718-00	A-S	90 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 50090-7420-00	A-S	100 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 50090-7421-00	A-S	90 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 50090-7674-00	A-S	100 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 50090-7675-00	A-S	90 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 51407-0048-10	Golden	1000 capsules	—	AB	Discontinued	—
Gabapentin 300 mg 53746-0102-01	Amneal	100 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 55154-7992-00	Cardinal	10 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 55154-8195-00	Cardinal	10 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 55700-0949-01	Quality	120 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 58118-1102-08	Clinical	30 capsules	—	AB	FDA listed	—
Gaba 300-EZS 59088-0725-00	PureTek	100 capsules	—	—	FDA listed	—
Gabapentin 300 mg 60760-0674-30	St.	30 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 60760-0741-60	St.	60 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 60760-0814-60	St	60 capsules	—	AB	FDA listed	—
Gabapentin 300 mgthis 61919-0640-30	DIRECT	30 capsules	—	AB	FDA listed	—
gabapentin 300 mg 62756-0138-01	Sun	50 capsules	—	—	FDA listed	—
Gabapentin 300 mg 63187-0810-00	Proficient	100 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 63187-0988-00	Proficient	100 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 63629-7306-01	Bryant	90 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 63629-8486-01	Bryant	500 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 63629-8487-01	Bryant	100 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 65162-0102-03	Amneal	30 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 67046-1284-03	Coupler	30 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 67046-1429-03	Coupler	30 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 68071-2366-01	NuCare	100 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 68071-2876-09	NuCare	90 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 68071-3527-03	NuCare	30 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 68071-4784-01	NuCare	100 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 68071-5193-03	NuCare	30 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 68788-7024-01	Preferred	100 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 68788-7848-00	Preferred	100 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 68788-8712-00	Preferred	100 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 69434-0043-03	Zhejiang	500 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 70518-0293-00	REMEDYREPACK	90 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 70518-1760-04	REMEDYREPACK	30 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 70518-2970-00	REMEDYREPACK	30 capsules	—	AB	Discontinued	—
Gabapentin 300 mg 70518-3329-00	REMEDYREPACK	100 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 70518-4411-00	REMEDYREPACK	90 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 71205-0295-15	Proficient	15 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 71205-0532-14	Proficient	14 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 71205-0766-30	Proficient	30 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 71205-0929-00	Proficient	100 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 71335-0220-00	Bryant	20 capsules	—	AB	Discontinued	—
Gabapentin 300 mg 71335-0993-01	Bryant	90 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 71335-1093-01	Bryant	90 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 71335-1197-00	Bryant	20 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 71335-1269-01	Bryant	90 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 71335-1348-00	Bryant	20 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 71335-1453-00	Bryant	20 capsules	—	AB	Discontinued	—
Gabapentin 300 mg 71335-1454-01	Bryant	90 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 71335-1490-00	Bryant	20 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 71335-1997-00	Bryant	20 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 71335-2004-01	Bryant	90 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 71335-2280-01	Bryant	1000 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 71335-2521-00	Bryant	20 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 71335-2699-00	Bryant	20 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 71335-2748-01	Bryant	90 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 71335-3109-01	Bryant	500 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 71610-0088-53	Aphena	60 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 71610-0143-60	Aphena	90 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 71610-0146-30	Aphena	30 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 71610-0185-30	Aphena	30 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 71610-0188-30	Aphena	30 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 71610-0211-60	Aphena	90 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 71610-0753-70	Aphena	120 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 72162-1533-01	Bryant	100 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 72162-1813-01	Bryant	100 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 72162-2139-01	Bryant	100 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 72189-0392-30	Direct_Rx	30 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 72189-0610-30	Direct_Rx	30 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 72737-0006-01	STALLION	30 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 72789-0055-30	PD-Rx	30 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 72865-0253-05	XLCare	500 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 76282-0627-01	Exelan	100 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 76420-0015-24	Asclemed	240 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 76420-0020-24	Asclemed	240 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 76420-0047-12	Asclemed	120 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 76420-0617-10	Asclemed	100 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 76420-0789-01	Asclemed	100 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 76420-0869-01	Asclemed	100 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 80425-0031-01	ADVANCED	30 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 80425-0032-01	Advanced	30 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 80425-0033-01	Advanced	30 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 80425-0079-01	Advanced	30 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 80425-0182-01	Advanced	30 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 80425-0196-01	Advanced	30 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 82619-0143-01	Creekwood	100 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 82804-0206-90	Proficient	90 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 82804-0217-30	Proficient	30 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 82868-0051-30	Northwind	30 capsules	—	AB	FDA listed	—
gabapentin 300 mg 82868-0073-30	Northwind	30 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 85509-2180-01	PHOENIX	100 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 87441-0035-01	Unit	30 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 85534-0056-00	HAWAII	30 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 85534-0007-00	HAWAII	30 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 70518-2911-00	REMEDYREPACK	100 capsules	—	AB	Discontinued	—
Gabapentin 300 mg 60760-0940-60	St.	60 capsules	—	AB	FDA listed	—
gabapentin 300 mg 67046-1644-03	Coupler	30 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 82868-0109-30	Northwind	30 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 67296-2299-04	Redpharm	21 capsules	—	AB	FDA listed	—
gabapentin 300 mg 68071-5317-01	NuCare	100 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 55154-0580-00	Cardinal	10 capsules	—	AB	FDA listed	—
Gabapentin 300 mg 70518-4746-00	REMEDYREPACK	30 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

🏛️

2015

On the market since

Dec 2015

📍

2026

Currently FDA-listed

11 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
61919-0640-30 You're viewing this	30 CAPSULE in 1 BOTTLE (61919-640-30)	2019-04-09	Active
61919-0640-72	120 CAPSULE in 1 BOTTLE (61919-640-72)	2019-08-08	Inactivated by FDA
61919-0640-60	60 CAPSULE in 1 BOTTLE (61919-640-60)	2019-08-08	Inactivated by FDA
61919-0640-82	180 CAPSULE in 1 BOTTLE (61919-640-82)	2019-08-19	Inactivated by FDA
61919-0640-90	90 CAPSULE in 1 BOTTLE (61919-640-90)	2019-08-19	Inactivated by FDA

You're viewing the smallest of 5 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 61919-0640-30?

NDC 61919-0640-30 is a 30-count package — 30 capsule in 1 bottle.

What is the difference between NDC 61919-0640-30 and NDC 61919-0640-60?

Both are GABAPENTIN 300 mg Capsule — the drug itself is identical. NDC 61919-0640-30 is the 30-count package, while NDC 61919-0640-60 is the 60 capsules package.

What NDC number is used to bill for this package of GABAPENTIN 300 mg Capsule?

Bill NDC 61919-0640-30 — the 11-digit billing format is 61919064030. 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
Package photos	✓ Available
Inactive ingredients (structured)	— Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS)	— Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data	✓ Available
HCPCS J-code billing crosswalk	— Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD)	— Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.

“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?

The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.

Is the NDC printed on the package the same as the 11-digit billing NDC?

Yes, they identify this exact package in different formats. The FDA registers it as 61919-640-30, 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: 61919-0640-30, written without dashes as 61919064030. 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 61919-0640-30, the first segment (61919) is the labeler code FDA assigned to DIRECT RX; the middle segment (0640) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (30) 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 DIRECT RX. 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 4 other package presentations of this same product, including 60 capsules (61919-0640-60), 90 capsules (61919-0640-90), 120 capsules (61919-0640-72). 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?

DIRECT RX 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 ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📋 Description 💬 Medication Guide

🎯 Indications and Usage 65 words ▾

INDICATIONS & USAGE SECTION Postherpetic Neuralgia Gabapentin is indicated for the management of postherpetic neuralgia in adults. Epilepsy Gabapentin is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in patients over 12 years of age with epilepsy. Gabapentin is also indicated as adjunctive therapy in the treatment of partial seizures in pediatric patients age 3 – 12 years.

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE & ADMINISTRATION SECTION Gabapentin Capsules, USP are given orally with or without food. If gabapentin dose is reduced, discontinued or substituted with an alternative medication, this should be done gradually over a minimum of 1 week (a longer period may be needed at the discretion of the prescriber). Postherpetic Neuralgia In adults with postherpetic neuralgia, gabapentin therapy may be initiated as a single 300-mg dose on Day 1, 600 mg/day on Day 2 (divided BID), and 900 mg/day on Day 3 (divided TID).

The dose can subsequently be titrated up as needed for pain relief to a daily dose of 1800 mg (divided TID). 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. Additional benefit of using doses greater than 1800 mg/day was not demonstrated.

Epilepsy Gabapentin is recommended for add-on therapy in patients 3 years of age and older. Effectiveness in pediatric patients below the age of 3 years has not been established. Patients >12 years of age: The effective dose of gabapentin is 900 to 1800 mg/day and given in divided doses (three times a day) using 300 or 400 mg capsules, or 600 or 800 mg tablets.

The starting dose is 300 mg three times a day. If necessary, the dose may be increased using 300 or 400 mg capsules, or 600 or 800 mg tablets three times a day up to 1800 mg/day. Dosages up to 2400 mg/day have been well tolerated 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, and have been well tolerated. The maximum time between doses in the TID schedule should not exceed 12 hours. Pediatric Patients Age 3–12 years: The starting dose should range from 10-15 mg/kg/day in 3 divided doses, and the effective dose reached by upward titration over a period of approximately 3 days.

The effective dose of gabapentin in patients 5 years of age and older is 25–35 mg/kg/day and given in divided doses (three times a day). The effective dose in pediatric patients ages 3 and 4 years is 40 mg/kg/day and given in divided doses (three times a day) (see CLINICAL PHARMACOLOGY, Pediatrics .) Gabapentin may be administered as the oral solution, capsule, or tablet, or using combinations of these formulations. Dosages up to 50 mg/kg/day have been well-tolerated in a long-term clinical study.

The maximum time interval between doses should not exceed 12 hours. It is not necessary to monitor gabapentin plasma concentrations to optimize gabapentin therapy. Further, because there are no significant pharmacokinetic interactions among gabapentin and other commonly used antiepileptic drugs, the addition of gabapentin does not alter the plasma levels of these drugs appreciably.

If gabapentin is discontinued and/or an alternate anticonvulsant medication is added to the therapy, this should be done gradually over a minimum of 1 week. Dosage in Renal Impairment Creatinine clearance is difficult to measure in outpatients. In patients with stable renal function, creatinine clearance (CCr) can be reasonably well estimated using the equation of Cockcroft and Gault: for females CCr=(0.

85)( 140-age)(weight)/[(72)(SCr)] for males CCr=(140-age)(weight)/[(72)(SCr)] where age is in years, weight is in kilograms and SCr is serum creatinine in mg/dL. Dosage adjustment in patients ≥ 12 years of age with compromised renal function or undergoing hemodialysis is recommended as follows (see dosing recommendations above for effective doses in each indication). TABLE 6.

Gabapentin Dosage Based on Renal Function Renal Function Creatinine Clearance (mL/min) Total Daily Dose Range (mg/day) Dose Regimen (mg) 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 hemod…

⛔ Contraindications 17 words ▾

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

⚠️ Warnings ~3 min read ▾

WARNINGS SECTION Suicidal Behavior and Ideation Antiepileptic drugs (AEDs), including gabapentin, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) of 11 different AEDs showed that patients randomized to one of the AEDs had approximately twice the risk (adjusted Relative Risk 1.8, 95% CI:1.2, 2.7) of suicidal thinking or behavior compared to patients randomized to placebo.

In these trials, which had a median treatment duration of 12 weeks, the estimated incidence rate of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal thinking or behavior for every 530 patients treated. There were four suicides in drug-treated patients in the trials and none in placebo-treated patients, but the number is too small to allow any conclusion about drug effect on suicide.

The increased risk of suicidal thoughts or behavior with AEDs was observed as early as one week after starting drug treatment with AEDs and persisted for the duration of treatment assessed. Because most trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or behavior beyond 24 weeks could not be assessed. The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed.

The finding of increased risk with AEDs of varying mechanisms of action and across a range of indications suggests that the risk applies to all AEDs used for any indication. The risk did not vary substantially by age (5-100 years) in the clinical trials analyzed. Table 2 shows absolute and relative risk by indication for all evaluated AEDs.

Table 2 Risk by indication for antiepileptic drugs in the pooled analysis Indication Placebo Patients with Events Per 1000 Patients Drug Patients With events per 1000 patients Relative Risk: Incidence of Events in Drug Patients /Incidence in Placebo Patients Risk Difference: Additional Drug Patients with Events Per 1000 Patients Epilepsy 1.0 3.4 3.5

2.4Psychiatric 5.7 8.5 1.5

2.9Other 1.0 1.8 1.9

0.9Total 2.4 4.3 1.8

1.9The relative risk for suicidal thoughts or behavior was higher in clinical trials for epilepsy than in clinical trials for psychiatric or other conditions, but the absolute risk differences were similar for the epilepsy and psychiatric indications. Anyone considering prescribing gabapentin or any other AED must balance the risk of suicidal thoughts or behavior with the risk of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior.

Should suicidal thoughts and behavior emerge during treatment, the prescriber needs to consider whether the emergence of these symptoms in any given patient may be related to the illness being treated. Patients, their caregivers, and families should be informed that AEDs increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of the signs and symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm.

Behaviors of concern should be reported immediately to healthcare providers. Neuropsychiatric Adverse Events—Pediatric Patients 3-12 years of age Gabapentin use in pediatric patients with epilepsy 3–12 years of age is associated with the occurrence of central nervous system related adverse events. The most significant of these can be classified into the following categories: 1) emotional lability (…

🤒 Adverse Reactions ~3 min read ▾

ADVERSE REACTIONS SECTION Postherptic Neuralgia The most commonly observed adverse events 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 studies 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 event. The adverse events that most frequently led to withdrawal in gabapentin-treated patients were dizziness, somnolence, and nausea.

Incidence in Controlled Clinical Trials Table 3 lists treatment-emergent signs and symptoms 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. Adverse events were usually mild to moderate in intensity. TABLE 3.

Treatment-Emergent Adverse Event Incidence in Controlled Trials in Postherpetic Neuralgia (Events in at least 1% of gabapentin -Treated Patients and Numerically More Frequent Than in the Placebo Group) Body System/ Gabapentin Placebo Preferred Term N=336 N=227 % % a Reported as blurred vision Body as a Whole Asthenia 5.7

4.8Infection 5.1

3.5Headache 3.3

3.1Accidental injury 3.3

1.3Abdominal pain 2.7

2.6Digestive System Diarrhea 5.7

3.1Dry mouth 4.8

1.3Constipation 3.9

1.8Nausea 3.9

3.1Vomiting 3.3

1.8Flatulence 2.1

1.8Metabolic and Nutritional Disorders Peripheral edema 8.3

2.2Weight gain 1.8

0.0Hyperglycemia 1.2

0.4Nervous System Dizziness 28.0

7.5Somnolence 21.4

5.3Ataxia 3.3

0.0Thinking abnormal 2.7

0.0Abnormal gait 1.5

0.0Incoordination 1.5

0.0Amnesia 1.2

0.9Hypesthesia 1.2

0.9Respiratory System Pharyngitis 1.2

0.4Skin and Appendages Rash 1.2

0.9Special Senses Amblyopiaa 2.7

0.9Conjunctivitis 1.2

0.0Diplopia 1.2

0.0Otitis media 1.2

0.0Other events 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 events. 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 events by race.

Epilepsy The most commonly observed adverse events associated with the use of 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 commonly observed adverse events reported with the use of gabapentin in combination with other antiepileptic drugs in pediatric patients 3 to 12 years of age, not seen at an equal frequency among placebo-treated patients, were viral infection, fever, nausea and/or vomiting, somnolence, and hostility (see WARNINGS, Neuropsychiatric Adverse Events ).

Approximately 7% of the 2074 patients >12 years of age and approximately 7% of the 449 pediatric patients 3 to 12 years of age who received gabapentin in premarketing clinical trials discontinued treatment because of an adverse event. The adverse events most commonly associated with withdrawal in patients >12 years of age were somnolence (1.2%), ataxia (0.8%), fatigue (0.6%), nausea and/or vomiting (0.6%), and dizziness (0.6%). The adverse events most commonly associated with withdrawal in pediatric patients were emotional lability (1.6%), hostility (1.3%), and hyperkinesias (1.1%).

Incidence in Controlled Clinical Trials Table 4 lists treatment-emergent signs and symptoms that occurred in at least 1% of gabapentin treated patients >12 years of age with epilepsy participating in placebo-controlled trials and were numerically more common in the gabapentin group. In these studies, either gabapentin or placebo was…

🆘 Overdosage 103 words ▾

OVERDOSAGE SECTION A lethal dose of gabapentin was not identified in mice and rats receiving single oral doses as high as 8000 mg/kg. Signs of acute toxicity in animals included ataxia, labored breathing, ptosis, sedation, hypoactivity, or excitation. Acute oral overdoses of gabapentin up to 49 grams have been reported.

In these cases, double vision, slurred speech, drowsiness, lethargy and diarrhea were observed. All patients recovered with supportive care. Gabapentin can be removed by hemodialysis.

Although hemodialysis has not been performed in the few overdose cases reported, it may be indicated by the patient’s clinical state or in patients with significant renal impairment.

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY SECTION Mechanism of Action: The mechanism by which gabapentin exerts its analgesic action is unknown, but in animal models of analgesia, gabapentin prevents allodynia (pain-related behavior in response to a normally innocuous stimulus) and hyperalgesia (exaggerated response to painful stimuli). In particular, gabapentin prevents pain-related responses in several models of neuropathic pain in rats or mice (e.g. spinal nerve ligation models, streptozocin-induced diabetes model, spinal cord injury model, acute herpes zoster infection model).

Gabapentin also decreases pain-related responses after peripheral inflammation (carrageenan footpad test, late phase of formalin test). Gabapentin did not alter immediate pain-related behaviors (rat tail flick test, formalin footpad acute phase, acetic acid abdominal constriction test, footpad heat irradiation test). The relevance of these models to human pain is not known.

The mechanism by which gabapentin exerts its anticonvulsant action is unknown, but in animal test systems designed to detect anticonvulsant activity, gabapentin prevents seizures as do other marketed anticonvulsants. Gabapentin exhibits antiseizure activity in mice and rats in both the maximal electroshock and pentylenetetrazole seizure models and other preclinical models (e.g., strains with genetic epilepsy, etc.). The relevance of these models to human epilepsy is not known.

Gabapentin is structurally related to the neurotransmitter GABA (gamma-aminobutyric acid) but it does not modify GABAA or GABAB radioligand binding, it is not converted metabolically into GABA or a GABA agonist, and it is not an inhibitor of GABA uptake or degradation. Gabapentin was tested in radioligand binding assays at concentrations up to 100 µM and did not exhibit affinity for a number of other common receptor sites, including benzodiazepine, glutamate, N-methyl-D-aspartate (NMDA), quisqualate, kainate, strychnine-insensitive or strychnine-sensitive glycine, alpha 1, alpha 2, or beta adrenergic, adenosine A1 or A2, cholinergic muscarinic or nicotinic, dopamine D1 or D2, histamine H1, serotonin S1 or S2, opiate mu, delta or kappa, cannabinoid 1, voltage-sensitive calcium channel sites labeled with nitrendipine or diltiazem, or at voltage-sensitive sodium channel sites labeled with batrachotoxinin A 20-alpha-benzoate.

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

However, functional correlates of gabapentin binding, if any, remain to be elucidated. Pharmacokinetics and Drug Metabolism 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 Cmax). 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 (Cmin) 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…

📋 Description 143 words ▾

DESCRIPTION SECTION Gabapentin Capsules, USP are supplied as imprinted hard gelatin capsules containing 100 mg, 300 mg and 400 mg of gabapentin, USP. The inactive ingredients are mannitol, pre-gelatinized starch and talc. The 100 mg capsule shell contains titanium dioxide.

The 300 mg capsule contains FD&C Red 40, D&C Yellow 10 and titanium dioxide. The 400 mg capsule shell contains FD&C Red 40, D&C Yellow 10 and titanium dioxide. Gabapentin, USP is described as 1-(aminomethyl) cyclohexaneacetic acid with a molecular formula of C9H17NO2 and a molecular weight of 171.24.

The structural formula of gabapentin is: Gabapentin, USP 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. image description

💬 Medication Guide 161 words ▾

Gabapentin Capsules, USP are supplied as follows: 100 mg : Hard Gelatin Capsules size "3" with White Opaque Cap and White Opaque Body imprinted with 100 mg and IG321, filled with White to Off-white powder; supplied in bottles of 100's count (NDC 31722-221-01) and 500's count (NDC 31722-221-05). 300 mg : Hard Gelatin Capsules size "1" with Yellow Opaque Cap and Yellow Opaque Body imprinted with 300 mg and IG322, filled with White to Off-white powder; supplied in bottles of 100's count (NDC 31722-222-01) and 500's count (NDC 31722-222-05).

400 mg : Hard Gelatin Capsules size "0" with Orange Opaque Cap and Orange Opaque Body imprinted with 400 mg and IG323, filled with White to Off-white powder; supplied in bottles of 100's count (NDC 31722-223-01) and 500's count (NDC 31722-223-05). Store at 20°-25°C (68°-7JOF). [See USP controlled room temperature.] Rx only Manufactured by: InvaGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Manufactured for: Camber Pharmaceuticals, Inc.

Piscataway, NJ 08854 Rev: 01/10 Barcode 323-01-2010

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.

abdominal pain: Pain, cramping, or discomfort felt anywhere in the belly area.

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

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

adverse event: Any unwanted medical problem that happens during treatment, whether or not the medicine actually caused it.

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

agonist: A substance that switches on a specific target in the body to produce an effect, the way a key turns a lock.

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.

Cmax: The highest level a medicine reaches in the blood after a dose is taken.

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.

drug metabolism: The body's chemical process, mainly in the liver, of changing a drug so it can be used or removed.

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.

emotional lability: Rapid, exaggerated mood changes that shift quickly from one feeling to another.

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

flatulence: Passing gas from the bowel; feeling bloated or gassy.

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.

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

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.

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

inhibitor: A substance that blocks an enzyme or transporter, which can raise the levels of drugs it normally handles.

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

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

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

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

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

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

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

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.

randomized: Assigned to a treatment group purely by chance, like a coin flip, so the groups being compared start out fair and similar.

receptor: A special docking spot on a cell that a medicine or natural body chemical attaches to in order to trigger an effect.

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.

Rx only: A label marking meaning the medicine can be obtained only with a prescription from a licensed health professional.

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.

serum creatinine: A waste product measured in a blood test; higher levels can mean the kidneys are not filtering as well as normal.

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

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.

treatment-emergent: Describes a side effect that first appears, or gets worse, after a person starts taking a treatment.

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

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

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 ↗

← 61919-0624-14 · DIRECT 61919-0642-05 · DirectRX →

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 300 mg Capsule, 30-count

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