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Gabapentin 600 mg Tablet, 90-count

by Epic Pharma, LLC · 90 TABLET in 1 BOTTLE (42806-657-09)

NDC 42806-0657-09

🏷️ FDA NDC (as labeled) 42806-657-09 billing pads the product segment with a zero

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) 42806-657-09

Product NDC 42806-657

11-digit billing NDC 42806065709

NCPDP billing unit EA — each (per item)

RxCUI 1806380, 1806382

UNII 6CW7F3G59X

Application # ANDA216252

SPL Set ID d592d828-8df1-480d-b179-bb9260a9c824

Physiologic effect Decreased Central Nervous System Disorganized Electrical Activity

DEA schedule Non-controlled

Marketing category ANDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2024-02-26

Route ORAL

Dosage form TABLET

Substance GABAPENTIN

GPI-14 62540030000330

GCN Seq No 067686

GCN 30296

HICL code 008831

Ingredient (HICL) Gabapentin

HIC1 code H

Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)

HIC2 code H0

Therapeutic class — intermediate (HIC2) Act On Non-Autonomic Nervous System

HIC3 code H0D

Therapeutic class — specific (HIC3) Postherpetic Neuralgia Agents

AHFS code 28:08.92.00

AHFS class Analgesics And Antipyretics, Misc.

FDB label name GABAPENTIN ER 600 MG TABLET

FDB brand name Gabapentin Er

Legend status F — Federal legend — prescription drug or device

TE code (Orange Book) AB2 · RLD · RS

Why two NDCs? The FDA registers this code as 42806-657-09 — 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 → 42806-0657-09. 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

LabelerEpic Pharma, LLC

Application holderEPIC PHARMA LLC

FDA applicationANDA216252 (ANDA)

Labeler code42806

First marketedFeb 2024

Product typeHuman Prescription Drug

Portfolio171 products on file

🔎 All NDCs from Epic Pharma, LLC

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 ER 600 MG TABLET Ingredient Gabapentin

📖 What it is MedlinePlus · NLM

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

Read the full MedlinePlus article ↗

📗 Our plain-language guide HelloPharmacist

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

📖 Read our full Gabapentin guide →

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 / Orange

ShapeOval

Imprint600

Size19 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 D9C330MD8B
Copovidone is a synthetic polymer made by combining two types of plastic-like molecules. It acts as a binder and film-former to help hold tablet ingredients together and improve how the medicine dissolves in your body.
UNII 35SW5USQ3G
A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
UNII WZB9127XOA
A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
UNII 3WJQ0SDW1A
Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
UNII 532B59J990
Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
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.

9 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 ea	Per package
Retail pharmacies payNADAC · weekly	$0.943	$84.90 / 90 tablets
Medicaid paysCMS SDUD · 12 mo	$2.09	$188.07 / 90 tablets
Medicare drug plans payPart D · Q2 2026	$3.80	$342.18 / 90 tablets

NADAC price history (per ea) — tap or hover for the price & month

▼ Down 38% over the last 9 months.

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 600 mg 71093-0111-04	ACI	100 tablets	$0.064	AB1	Availability likely	save 93%
Gabapentin 600 mg 76282-0405-01	Exelan	100 tablets	$0.064	—	Availability likely	save 93%
Gabapentin 600 mg 82009-0071-05	QUALLENT	500 tablets	$0.064	AB1	Availability likely	save 93%
Gabapentin 600 mg 16714-0330-01	NorthStar	100 tablets	$0.064	AB1	Availability likely	save 93%
Gabapentin 600 mg 68462-0126-01	Glenmark	100 tablets	$0.064	AB1	Availability likely	save 93%
Gabapentin 600 mg 16571-0226-01	Rising	100 tablets	$0.064	AB1	Availability likely	save 93%
Gabapentin 600 mg 65862-0523-01	Aurobindo	100 tablets	$0.064	AB1	Availability likely	save 93%
Gabapentin 600 mg 31722-0166-01	Camber	100 tablets	$0.064	AB1	Availability likely	save 93%
Gabapentin 600 mg 68382-0204-01	Zydus	100 tablets	$0.064	AB1	Availability likely	save 93%
Gabapentin 600 mg 69367-0346-05	Westminster	500 tablets	$0.064	AB1	Availability likely	save 93%
Gabapentin 600 mg 00904-6823-61	Major	1 tablet	$0.064	AB1	Availability likely	save 93%
Gabapentin 600 mg 60687-0507-01	American	1 tablet	$0.064	AB1	Availability likely	save 93%
Gabapentin 600 mg 83301-0001-01	Mullan	100 tablets	$0.064	AB1	Availability likely	save 93%
Gabapentin 600 mg 50228-0177-01	ScieGen	100 tablets	$0.064	AB1	Availability likely	save 93%
Gabapentin 600 mg 68001-0411-00	BluePoint	100 tablets	$0.064	AB1	Availability likely	save 93%
Gabapentin 600 mg 68094-0589-50	Precision	100 tablets	$0.064	AB1	Availability likely	save 93%
Gabapentin 600 mg 67877-0428-01	Ascend	100 tablets	$0.064	AB1	Availability likely	save 93%
Gabapentin 600 mg 50268-0325-15	AvPAK	1 tablet	$0.064	AB1	Availability likely	save 93%
Gabapentin 600 mg 70010-0227-01	Granules	100 tablets	$0.064	AB1	Availability likely	save 93%
Gabapentin 600 mg 64380-0727-01	Strides	100 tablets	$0.064	AB1	Availability likely	save 93%
Gabapentin 600 mg 76282-0706-05	Exelan	500 tablets	$0.064	AB1	Availability likely	save 93%
Gabapentin 600 mg 68094-0069-61	Precision	10 tablets	$0.064	AB1	Availability likely	save 93%
gabapentin 600 mg 62756-0202-01	Sun	100 tablets	$0.068	—	FDA listed	save 93%
Gabapentin 600 mg 51224-0021-50	TAGI	100 tablets	$0.098	AB1	Discontinued	save 90%
Gabapentin 600 mg 31722-0092-90	Camber	90 tablets	$0.943	AB2	Availability likely	—
Gabapentin 600 mgthis 42806-0657-09	Epic	90 tablets	$0.943	AB2	Availability likely	—
Gralise 600 mg 52427-0806-90	Almatica	90 tablets	$10.158	AB2	Availability likely	+977%
Neurontin 600 mg 00071-0513-24	Parke-Davis	100 tablets	$14.084	AB1	Discontinued	+1393%
Neurontin 600 mg 58151-0284-01	Viatris	100 tablets	$14.084	AB1	Availability likely	+1393%
gabapentin 600 mg 50228-0524-05	ScieGen	500 tablets	—	AB2	FDA listed	—
gabapentin 600 mg 68382-0607-05	Zydus	500 tablets	—	AB2	FDA listed	—
gabapentin 600 mg 70771-1862-04	Zydus	100 tablets	—	AB2	FDA listed	—
Gabapentin 600 mg 63187-0057-00	Proficient	100 tablets	—	AB1	FDA listed	—
Gabapentin 600 mg 63187-0785-00	Proficient	100 tablets	—	—	FDA listed	—
Gabapentin 600 mg 71205-0457-30	Proficient	30 tablets	—	AB1	FDA listed	—
Gabapentin 600 mg 71205-0533-30	Proficient	30 tablets	—	AB1	FDA listed	—
Gabapentin 600 mg 71205-0931-00	Proficient	100 tablets	—	AB1	FDA listed	—
Gabapentin 600 mg 71610-0044-30	Aphena	30 tablets	—	AB1	FDA listed	—
gabapentin 600 mg 71610-0069-45	Aphena	45 tablets	—	—	FDA listed	—
Gabapentin 600 mg 71610-0621-15	Aphena	15 tablets	—	AB1	FDA listed	—
Gabapentin 600 mg 76420-0235-12	Asclemed	120 tablets	—	AB1	FDA listed	—
Gabapentin 600 mg 60760-0987-90	St.	90 tablets	—	AB1	FDA listed	—
Gabapentin 600 mg 69097-0812-02	Cipla	30 tablets	—	—	FDA listed	—
Gabapentin 600 mg 71610-0767-30	Aphena	30 tablets	—	AB1	FDA listed	—
Gabapentin 600 mg 72162-2141-01	Bryant	100 tablets	—	AB1	FDA listed	—
Gabapentin 600 mg 82804-0015-30	Proficient	30 tablets	—	AB1	FDA listed	—
Gabapentin 600 mg 82804-0193-30	Proficient	30 tablets	—	AB1	FDA listed	—
Gabapentin 600 mg 42385-0979-01	Laurus	100 tablets	—	AB1	FDA listed	—
Gabapentin 600 mg 50090-6854-00	A-S	90 tablets	—	AB1	FDA listed	—
Gabapentin 600 mg 55154-8189-00	Cardinal	1 tablet	—	AB1	FDA listed	—
Gabapentin 600 mg 63629-7307-01	Bryant	90 tablets	—	AB1	FDA listed	—
Gabapentin 600 mg 70518-2098-00	REMEDYREPACK	30 tablets	—	AB1	FDA listed	—
Gabapentin 600 mg 71335-1200-00	Bryant	28 tablets	—	AB1	FDA listed	—
Gabapentin 600 mg 71610-0777-30	Aphena	30 tablets	—	AB1	FDA listed	—
Gabapentin 600 mg 76420-0836-01	Asclemed	100 tablets	—	AB1	FDA listed	—
Gabapentin 600 mg 82619-0145-01	Creekwood	100 tablets	—	AB1	FDA listed	—
Gabapentin 600 mg 58118-0166-08	Clinical	30 tablets	—	AB1	FDA listed	—
Gabapentin 600 mg 63629-8492-01	Bryant	100 tablets	—	AB1	FDA listed	—
Gabapentin 600 mg 67046-1535-03	Coupler	30 tablets	—	AB1	FDA listed	—
Gabapentin 600 mg 71335-2281-01	Bryant	500 tablets	—	AB1	FDA listed	—
Gabapentin 600 mg 71335-2719-01	Bryant	90 tablets	—	AB1	FDA listed	—
Gabapentin 600 mg 50090-7715-00	A-S	90 tablets	—	AB1	FDA listed	—
Gabapentin 600 mg 68788-8476-01	Preferred	100 tablets	—	AB1	FDA listed	—
Gabapentin 600 mg 68788-8488-01	Preferred	100 tablets	—	AB1	FDA listed	—
Gabapentin 600 mg 70518-2842-00	REMEDYREPACK	28 tablets	—	AB1	Discontinued	—
Gabapentin 600 mg 72888-0131-00	Advagen	1000 tablets	—	AB1	FDA listed	—
Gabapentin 600 mg 80425-0097-01	Advanced	30 tablets	—	AB1	FDA listed	—
Gabapentin 600 mg 83008-0063-60	Quality	60 tablets	—	AB1	Discontinued	—
Gabapentin 600 mg 50090-6855-00	A-S	90 tablets	—	AB1	FDA listed	—
Gabapentin 600 mg 55289-0959-30	PD-Rx	30 tablets	—	AB1	FDA listed	—
Gabapentin 600 mg 65841-0705-01	Zydus	100 tablets	—	AB1	FDA listed	—
Gabapentin 600 mg 68071-3445-03	NuCare	30 tablets	—	AB1	FDA listed	—
Gabapentin 600 mg 70518-2616-03	REMEDYREPACK	30 tablets	—	AB1	Discontinued	—
Gabapentin 600 mg 71335-3060-00	Bryant	28 tablets	—	AB1	FDA listed	—
Gabapentin 600 mg 72162-1530-01	Bryant	100 tablets	—	AB1	FDA listed	—
Gabapentin 600 mg 72189-0471-30	Direct_Rx	30 tablets	—	AB1	FDA listed	—
Gabapentin 600 mg 72865-0255-05	XLCare	500 tablets	—	AB1	FDA listed	—
Gabapentin 600 mg 70518-4532-00	REMEDYREPACK	1 tablet	—	AB1	FDA listed	—
Gabapentin 600 mg 72789-0127-30	PD-Rx	30 tablets	—	AB1	FDA listed	—
Gabapentin 600 mg 77771-0177-05	Radha	500 tablets	—	AB1	FDA listed	—
Gabapentin 600 mg 80425-0201-01	Advanced	30 tablets	—	AB1	FDA listed	—
Gabapentin 600 mg 55154-3357-00	Cardinal	1 tablet	—	AB1	FDA listed	—
Gabapentin 600 mg 68071-3783-09	NuCare	90 tablets	—	AB1	FDA listed	—
Gabapentin 600 mg 71335-3143-01	Bryant	90 tablets	—	AB1	FDA listed	—
Gabapentin 600 mg 82804-0210-90	Proficient	90 tablets	—	AB1	FDA listed	—
Gabapentin 600 mg 60760-0066-60	St.	60 tablets	—	AB1	Discontinued	—
Gabapentin 600 mg 71335-1132-00	Bryant	28 tablets	—	AB1	Discontinued	—
Gabapentin 600 mg 71335-1287-00	Bryant	28 tablets	—	AB1	FDA listed	—
Gabapentin 600 mg 72189-0313-60	Directrx	60 tablets	—	AB1	FDA listed	—
Gabapentin 600 mg 50090-7268-00	A-S	90 tablets	—	AB1	FDA listed	—
Gabapentin 600 mg 63629-3063-00	Bryant	45 tablets	—	AB1	FDA listed	—
Gabapentin 600 mg 63629-8491-01	Bryant	500 tablets	—	AB1	FDA listed	—
Gabapentin 600 mg 70518-2356-00	REMEDYREPACK	30 tablets	—	AB1	FDA listed	—
Gabapentin 600 mg 71335-2048-01	Bryant	90 tablets	—	AB1	FDA listed	—
Gabapentin 600 mg 71335-2701-00	Bryant	28 tablets	—	AB1	FDA listed	—
Gabapentin 600 mg 50090-7269-00	A-S	90 tablets	—	AB1	FDA listed	—
Gabapentin 600 mg 50090-7714-00	A-S	90 tablets	—	AB1	FDA listed	—
Gabapentin 600 mg 60760-0743-90	St.	90 tablets	—	AB1	FDA listed	—
Gabapentin 600 mg 71335-1026-01	Bryant	90 tablets	—	AB1	Discontinued	—
Gabapentin 600 mg 87441-0036-01	Unit	30 tablets	—	AB1	FDA listed	—
Gabapentin 600 mg 85534-0009-00	HAWAII	30 tablets	—	AB1	FDA listed	—
Gabapentin 600 mg 67046-1086-03	Coupler	30 tablets	—	AB1	FDA listed	—
Gabapentin 600 mg 67046-1233-03	Coupler	30 tablets	—	AB1	FDA listed	—
Gabapentin 600 mg 85509-1166-03	PHOENIX	30 tablets	—	AB1	FDA listed	—
Gabapentin 600 mg 58118-2126-08	Clinical	30 tablets	—	AB1	FDA listed	—

About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.

Where does this data come from?

Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️

2024

On the market since

Feb 2024

📍

2026

Currently FDA-listed

2 years listed

🔓

Generic on the market

this product is a generic

✅This is a generic drug

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

Where does this data come from?

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

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 42806-0657-09, not the drug overall. Other pack sizes report separately.

💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.

📅 Q1 2025 – Q4 2025 · 4 quarters of data

ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.

Prescriptions last 4 qtrs

607

Units reimbursed last 4 qtrs

41.5K

Gross reimbursed last 4 qtrs

$86.7K

Avg / prescription

$142.81

Avg / unit

$2.0897

Latest quarter Q4 2025

146Rx

Medicaid pays / ea

$2.0897

gross reimbursed

NADAC / ea

$0.9433

acquisition cost

Spread

+$1.1464

+122% vs cost

What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.

Fee-for-service vs managed care ⓘ

47% FFS 53% MCO

Fee-for-service · 288 Rx Managed care · 319 Rx

State Medicaid map

Units reimbursed · per 100k residents

19.1129

gray = no data reported ⓘ

Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.

Tap or hover a state

…for its Medicaid breakdown

🏆 Top states by units · per 100k residents

1 Connecticut 129 /100k

2 Michigan 86.0 /100k

3 Kentucky 60.6 /100k

4 Indiana 53.8 /100k

5 North Carolina 47.1 /100k

6 New York 37.9 /100k

7 Alabama 34.8 /100k

8 California 19.1 /100k

National units — by quarter

💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

📊 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
42806-0657-09 You're viewing this	90 TABLET in 1 BOTTLE (42806-657-09)	2024-02-26	Active

📄 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 74 words ▾

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

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

⏱️ Dosage and Administration ~2 min read ▾

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

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

( 2.2 )

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

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

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

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

💊 Dosage Forms and Strengths 56 words ▾

3 DOSAGE FORMS AND STRENGTHS Tablets: 300 mg: white, oval-shaped, film-coated tablets debossed with “300” above “ ” on one side and plain on the other side. 600 mg: orange, oval-shaped, film-coated tablets debossed with “600” above “ ” on one side and plain on the other side. 300 and 600 mg tablets ( 3 )

⛔ Contraindications 36 words ▾

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

⚠️ Warnings and Cautions ~3 min read ▾

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

( 5.1 ) • Abrupt or rapid discontinuation may increase the risk for seizures. Withdrawal symptoms or suicidal behavior and ideation have been observed after discontinuation. Taper gabapentin tablets gradually over a minimum of 1 week.

( 5.2 ) • Respiratory depression may occur with gabapentin tablets when used with concomitant CNS depressants or in the setting of underlying respiratory impairment. Monitor patients and adjust dosage as appropriate. ( 5.3 )

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

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

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

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

Table 3 shows absolute and relative risk by indication for all evaluated AEDs. Table 3: Risk by Indication for Antiepileptic Drugs (including gabapentin, the active ingredient in gabapentin tablets) in the Pooled Analysis Indication Placebo Patients with Events Per 1,000 Patients Drug Patients with Events Per 1,000 Patients Relative Risk: Incidence of Events in Drug Patients/Incidence in Placebo Patients Risk Difference: Additional Drug Patients with Events Per 1,000 Patients Epilepsy 1.0 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 tablets must…

🤒 Adverse Reactions ~3 min read ▾

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

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Epic Pharma, LLC at 1-888-374-2791 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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

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

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

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

0.8General Disorders Peripheral edema Pain 3.9 1.1 0.3

0.5Infections and Infestations Nasopharyngitis Urinary tract infection 2.5 1.7 2.2

0.5Investigations Weight increased 1.9

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

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

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

6.2Postmarketing and Other Experience with other Formulations of Gabapentin In addition to the adverse experiences reported during clinical testing of gabapentin, the following adverse experiences have been reported in patients receiving other formulations of marketed gabapentin. These adverse experiences have not been listed above and data are insufficient to support an estimate of their incidence or to establish causation. The listing is alphabetized: angioedema, blood glucose fluctuati…

🔄 Drug Interactions ~3 min read ▾

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

Gabapentin is not appreciably metabolized nor does it interfere with the metabolism of commonly coadministered antiepileptic drugs. The drug interaction data described in this section were obtained from studies involving healthy adults and adult patients with epilepsy. • An increase in gabapentin AUC values have been reported when administered with hydrocodone. ( 7.6 ) • An increase in gabapentin AUC values have been reported when administered with morphine.

( 7.7 ) • An antacid containing aluminum hydroxide and magnesium hydroxide reduced the bioavailability of gabapentin immediate release by about approximately 20%, but by only 5% when gabapentin was taken 2 hours after antacids. It is recommended that gabapentin tablets be taken at least 2 hours following antacid administration. ( 7.10 )

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

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

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

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

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

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

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

7.8Cimetidine Cimetidine 300 mg decreased the apparent oral clearance of gabapentin by 14% and creatinine clearance by 10%. The effect of gabapentin immediate release on…

👥 Use in Specific Populations ~3 min read ▾

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

8.1Pregnancy Risk Summary Available data from published prospective and retrospective cohort studies, and case reports over decades of use with gabapentin during pregnancy have not identified a drug-associated risk of major birth defects. The available data are insufficient to evaluate a drug-associated risk of miscarriage and other maternal or fetal outcomes. In nonclinical studies in mice, rats, and rabbits, gabapentin was developmentally toxic (increased fetal skeletal and visceral abnormalities, and increased embryofetal mortality) when administered to pregnant animals at doses similar to those used clinically (see Data ).

Postmarketing data suggest that extended gabapentin use with opioids close to delivery may increase the risk of neonatal withdrawal versus opioids alone [see Clinical Considerations] . Although there is at least one report of neonatal withdrawal syndrome in an infant exposed to gabapentin alone during pregnancy, there are no comparative epidemiologic studies evaluating this association. Therefore, it is not known whether exposure to gabapentin alone late in pregnancy may cause withdrawal signs and symptoms.

The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Clinical Considerations Fetal/Neonatal Adverse Reactions Neonatal withdrawal syndrome has been reported in newborns exposed to gabapentin in utero for an extended period of time when also exposed to opioids close to delivery. Neonatal withdrawal signs and symptoms reported have included tachypnea, vomiting, diarrhea, hypertonia, irritability, sneezing, poor feeding, hyperactivity, abnormal sleep pattern, and tremor. Reported signs and symptoms that may also be related to withdrawal include tongue thrusting, wandering eye movements while awake, back arching, and continuous extremity movements.

Observe neonates exposed to gabapentin tablets and opioids for signs and symptoms of neonatal withdrawal and manage accordingly. Data Animal Data When pregnant mice received oral doses of gabapentin (1,000 or 3,000 mg/kg/day, approximately 3 to 8 times the maximum recommended dose of 1,800 mg on a mg/m 2 basis) during the period of organogenesis, embryofetal toxicity (increased incidences of skeletal variations) was observed. The no effect level was 500 mg/kg/day, representing approximately the maximum recommended human dose [MRHD] on a mg/m 2 basis.

When rats were dosed prior to and during mating, and throughout gestation, pups from all dose groups (500, 1,000 and 2,000 mg/kg/day) were affected. These doses are equivalent to approximately 3 to 11 times the MRHD on a mg/m 2 basis. There was an increased incidence of hydroureter and/or hydronephrosis in rats in a study of fertility and general reproductive performance at 2,000 mg/kg/day with no effect at 1,000 mg/kg/day, in a teratology study at 1,500 mg/kg/day with no effect at 300 mg/kg/day, and in a perinatal and postnatal study at all doses studied (500, 1,000 and 2,000 mg/kg/day).

The doses at which the effects occurred are approximately 3 to 11 times the maximum recommended dose of 1,800 mg on a mg/m 2 basis; the no-effect doses were approximately 5 times (Fertility and General Reproductive Performance study) and approximately equal to (Teratogenicity study) the MRHD on a mg/m 2 basis. Other than hydroureter and hydronephrosis, the etiologies of which are unclear, the incidence of malformations was not increased compared to cont…

🤰 Pregnancy ~3 min read ▾

When pregnant rabbits were treated with gabapentin during the period of organogenesis, an increase in em…

🧒 Pediatric Use 28 words ▾

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

🧓 Geriatric Use 89 words ▾

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

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

🆘 Overdosage 90 words ▾

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

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

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

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

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

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

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

12.2Pharmacodynamics No pharmacodynamic studies have been conducted with gabapentin tablets.

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

Time to reach maximum plasma concentration (T max ) for gabapentin tablets is 8 hours, which is about 4 to 6 hours longer compared to gabapentin immediate release. Table 5: Mean ± SD Steady-State Pharmacokinetics for Gabapentin Tablets and Gabapentin Immediate Release in Healthy Subjects under high-fat high calorie fed state (Day 5, n = 21) Pharmacokinetic Parameter (Mean ± SD) Gabapentin Tablets 1,800 mg QD (3 X 600 mg) Gabapentin Immediate Release 600 mg TID AUC 0-24 (mcg ● hr/mL) 132.8 ± 34.7 141.3 ±

29.8C max (mcg/mL) 9.59 ± 2.33 8.54 ±

1.72C min (mcg/mL) 1.84 ± 0.65 2.6 ±

0.78T max (hr) 1 8 (3-12) 2 (1-5) * 1 T max is presented as median (range); *relative to most recent dose The single dose pharmacokinetic parameters of 900 mg strength under high fat-high calorie fed state and low fat-low calorie fed state are presented shown in Table 6. Table 6: Mean ± SD Single-Dose Pharmacokinetic parameters for Gabapentin tablets 900 mg stren…

🧬 Mechanism of Action ~2 min read ▾

📦 How Supplied / Storage and Handling 105 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Once-daily Gabapentin Tablets are supplied as follows: 300 mg tablets: Gabapentin 300 mg tablets are white, oval film-coated tablet debossed with “300” above “ ” on one side and plain on the other side. NDC 42806-656-09 (Bottle of 90) 600 mg tablets: Gabapentin 600 mg tablets are orange, oval film-coated tablet debossed with “600” above “ ” on one side and plain on the other side. NDC 42806-657-09 (Bottle of 90) Storage Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature].

Keep out of reach of children.

📋 Description 185 words ▾

11 DESCRIPTION Gabapentin tablets contain gabapentin, a gamma-aminobutyric acid (GABA) analogue, as the active pharmaceutical ingredient. Gabapentin’s chemical name is 1-(aminomethyl)cyclohexaneacetic acid; with a molecular formula of C 9 H 17 NO 2 and a molecular weight of 171.24 g/mol. Gabapentin chemical structural formula is: Gabapentin 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 acidic and basic solutions. The log of the partition coefficient (n-octanol/ 0.05M phosphate buffer) at pH 7.4 is -1.25. Gabapentin is intended for oral administration and is supplied as tablets containing 300 mg or 600 mg of gabapentin.

Each 300 mg tablet contains the inactive ingredients copovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene oxide, and Opadry ® II white. Opadry ® II white contains polyvinyl alcohol, polyethylene glycol, titanium dioxide, and talc. Each 600 mg tablet contains the inactive ingredients copovidone, hypromellose, magnesium stearate, polyethylene oxide, and Opadry ® II orange.

Opadry ® II orange contains D&C yellow #10 aluminum lake, FD&C red #40 aluminum lake, polyvinyl alcohol, polyethylene glycol, titanium dioxide, and talc. structure-formula.jpg

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise patients of the availability of a Medication Guide, and instruct them to read the Medication Guide prior to taking gabapentin tablets. • Advise patients that once-daily gabapentin tablets are not substitutable with other formulations of gabapentin. • Advise patients to take gabapentin tablets only as prescribed. Gabapentin tablets may cause dizziness, somnolence, and other signs and symptoms of CNS depression. • Advise patients not to drive or operate other complex machinery until they have gained sufficient experience on gabapentin tablets to gauge whether or not it adversely affects their mental and/or motor performance.

Advise patients who require concomitant treatment with morphine to tell their prescriber if they develop signs of CNS depression such as somnolence. If this occurs the dose of gabapentin tablets or morphine should be reduced accordingly. • Advise patients that if they miss a dose of gabapentin tablets to take it with food as soon as they remember. If it is almost time for the next dose, just skip the missed dose and take the next dose at the regular time.

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

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

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

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

Do not split, crush, or chew the tablets [see Dosage and Administration (2.1) ]. Use in Pregnancy Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with gabapentin tablets, and to notify their physician if they are breast feeding or intend to breast feed during therapy [ see Use in Specific Populations (8.1) and (8.2) ]. Distributed by: Epic pharma, LLC Laurelton, NY 11413 LN0006 MF656REV09/25 Rev.

09-2025-00 All Product/Brand names are the trademarks of their respective owners.

💬 Medication Guide ~3 min read ▾

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

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

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

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

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

Do not stop taking gabapentin tablets without first talking with your healthcare provider. • Stopping gabapentin tablets suddenly can cause serious problems. What are gabapentin tablets? Gabapentin tablets are prescription medicine used in adults, 18 years and older, to treat: • pain from damaged nerves (neuropathic pain) that follows healing of shingles (a painful rash that comes after a herpes zoster infection).

It is not known if gabapentin tablets are safe and effective in people with seizure problems (epilepsy). It is not known if gabapentin tablets are safe and effective in children under 18 years of age with postherpetic pain. Once-daily gabapentin tablets are not substitutable with other gabapentin products.

Who should not take gabapentin tablets? Do not take gabapentin tablets if you are allergic to gabapentin or any of the ingredients in gabapentin tablets. See the end of this Medication Guide for a complete list of ingredients in gabapentin tablets.

What should I tell my healthcare provider before taking gabapentin tablets? Before taking gabapentin tablets, tell your healthcare provider if you: • have or have had depression, mood problems or suicidal thoughts or behavior • have breathing problems • have seizures • have kidney problems or get kidney dialysis • are pregnant or plan to become pregnant. It is not known if gabapentin tablets can harm your unborn baby.

Tell your healthcare provider right away if you become pregnant while taking gabapentin tablets. You and your healthcare provider will decide if you should take gabapentin tablets while you…

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.

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.

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

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.

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.

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

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.

controlled-release: Made to release medicine at a steady, planned rate over time instead of all at once; sometimes labeled CR.

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

CYP1A2: A liver enzyme that breaks down certain medicines and whose activity can be changed by cigarette smoke.

CYP2C19: A liver enzyme that breaks down certain medicines, such as some stomach-acid drugs and drugs that help prevent blood clots.

CYP2C9: A liver enzyme that breaks down certain medicines, including some blood thinners and anti-inflammatory drugs.

CYP2D6: A liver enzyme that breaks down many medicines; people inherit different versions, so it works faster in some and slower in others.

CYP3A4: One of the most important liver and gut enzymes, responsible for breaking down a large share of all medicines.

cytochrome P450: A large family of enzymes, mostly in the liver, that break down many medicines so the body can remove them.

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

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

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.

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

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.

fertility: The natural ability to become pregnant or to father a child.

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.

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

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

hypertension: Blood pressure that stays higher than normal, commonly called high blood pressure.

in utero: Inside the womb, describing a baby before it is born.

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.

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

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

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

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

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

maximum recommended dose: The largest amount of a medicine that should be taken within a given period.

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.

nasopharyngitis: Inflammation of the nose and throat, commonly known as the common cold.

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.

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.

plasma concentration: The amount of medicine measured in the liquid part of the blood at a given time.

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

pyrexia: A raised body temperature; a fever.

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 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.

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.

steady state: The point where the amount of medicine going in equals the amount leaving, so blood levels stay fairly even.

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

tachypnea: Breathing that is faster than normal.

taper: Gradually lowering a dose in steps before stopping, rather than quitting all at once.

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.

trough: The lowest level a medicine reaches in the blood, just before the next dose is due.

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

vertigo: A spinning sensation that makes you feel like you or the room around you is moving.

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 ↗

← 42806-0656-09 · Epic 42806-0658-30 · EPIC →

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 600 mg Tablet, 90-count

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