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Gabapentin 800 mg Tablet, Coated, 120-count — NDC 80425-0204-04 package photo

Gabapentin 800 mg Tablet, Coated, 120-count

by Advanced Rx of Tennessee, LLC · 120 TABLET, COATED in 1 BOTTLE (80425-0204-4)
NDC 80425-0204-04
🏷️ FDA NDC (as labeled) 80425-0204-4 billing pads the package segment with a zero
This package
Contains120-count Pack sizes4 compare ↓
Also priced by: Part D plans $0.1683/unit — full pricing hub ↓
Also comes in: 30 tablets 80425-0204-01 60 tablets 80425-0204-02 90 tablets 80425-0204-03
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Gabapentin (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Oct 10, 2025 — Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity . (The Harvard Drug Group LLC) · FDA recall D-0031-2026
Class II · Oct 10, 2025 — Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity . (The Harvard Drug Group LLC) · FDA recall D-0030-2026
Class II · Jun 19, 2025 — Defective container; blister packaging inadequately sealed. (The Harvard Drug Group LLC) · FDA recall D-0507-2025
Class II · Jun 19, 2025 — Defective container; blister packaging inadequately sealed. (The Harvard Drug Group LLC) · FDA recall D-0508-2025
Class II · Mar 13, 2025 — CGMP Deviations (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0320-2025
Class III · Mar 4, 2025 — Cross Contamination (SUN PHARMACEUTICAL INDUSTRIES INC) · FDA recall D-0312-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 80425-0204-4
Product NDC 80425-0204
11-digit billing NDC 80425020404
NCPDP billing unit EA — each (per item)
RxCUI 310433, 310434
UNII 6CW7F3G59X
Application # ANDA207057
SPL Set ID ec1a01fe-5531-21df-e053-2a95a90a0561
Physiologic effect Decreased Central Nervous System Disorganized Electrical Activity
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-10-28
Route ORAL
Dosage form TABLET, COATED
Substance GABAPENTIN
TE code (Orange Book) AB1 · RLD · RS
Why two NDCs? The FDA registers this code as 80425-0204-4 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 80425-0204-04. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Gabapentinoids class.

Drug family (ATC) Gabapentinoids
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerAdvanced Rx of Tennessee, LLC
Application holderCSPC OUYI PHARMACEUTICAL CO LTD
FDA applicationANDA207057 (ANDA)
Labeler code80425
First marketedOct 2022
Product typeHuman Prescription Drug
Portfolio278 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📖 What it is MedlinePlus · NLM

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

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Gabapentin is mainly used for two things: managing nerve pain that lingers after a shingles infection (called postherpetic neuralgia) in adults, and helping control partial onset s...
  • This is a really important question. Taking gabapentin together with opioids like morphine, hydrocodone, or oxycodone significantly raises the risk of serious breathing problems —...
  • Can I take gabapentin with my opioid pain medication?
  • The most common ones — especially in the first few weeks — are dizziness, drowsiness, and sometimes loss of balance or coordination. Swelling in the feet or hands is also fairly co...
📖 Read our full Gabapentin guide →
1
Nutrient depletion considerations

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

🧪 Full Gabapentin nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color white
ShapeOval
ImprintO;E;600
Size17 mm
ScoringScored — splits in 2
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

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

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.1683 $20.20 / 120 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Gabapentin 800 mg 00904-7108-61 Major 1 tablet $0.090 AB1 Availability likely —
Gabapentin 800 mg 16571-0117-01 Rising 100 tablets $0.090 AB1 Availability likely —
Gabapentin 800 mg 16714-0332-01 NorthStar 100 tablets $0.090 AB1 Availability likely —
Gabapentin 800 mg 31722-0167-01 Camber 100 tablets $0.090 AB1 Availability likely —
Gabapentin 800 mg 50228-0178-01 ScieGen 100 tablets $0.090 AB1 Availability likely —
Gabapentin 800 mg 50268-0326-13 AvPAK 1 tablet $0.090 AB1 Discontinued —
Gabapentin 800 mg 60687-0518-01 American 1 tablet $0.090 AB1 Availability likely —
Gabapentin 800 mg 64380-0728-01 Strides 100 tablets $0.090 AB1 Availability likely —
Gabapentin 800 mg 65862-0524-01 Aurobindo 100 tablets $0.090 AB1 Availability likely —
Gabapentin 800 mg 67877-0429-01 Ascend 100 tablets $0.090 AB1 Availability likely —
Gabapentin 800 mg 68001-0412-00 BluePoint 100 tablets $0.090 AB1 Availability likely —
Gabapentin 800 mg 68094-0489-50 Precision 100 tablets $0.090 AB1 Availability likely —
Gabapentin 800 mg 68382-0205-01 Zydus 100 tablets $0.090 AB1 Availability likely —
Gabapentin 800 mg 68462-0127-01 Glenmark 100 tablets $0.090 AB1 Availability likely —
Gabapentin 800 mg 69367-0347-05 Westminster 500 tablets $0.090 AB1 Availability likely —
Gabapentin 800 mg 70010-0228-01 Granules 100 tablets $0.090 AB1 Availability likely —
Gabapentin 800 mg 76282-0406-01 Exelan 100 tablets $0.090 — Availability likely —
Gabapentin 800 mg 76282-0707-05 Exelan 500 tablets $0.090 AB1 Availability likely —
Gabapentin 800 mg 82009-0072-05 QUALLENT 500 tablets $0.090 AB1 Availability likely —
Gabapentin 800 mg 83301-0002-01 Mullan 100 tablets $0.090 AB1 Availability likely —
Gabapentin 800 mg 71093-0112-04 ACI 100 tablets $0.098 AB1 Availability likely —
gabapentin 800 mg 62756-0204-01 Sun 100 tablets $0.098 — FDA listed —
Gabapentin 800 mg 51224-0121-50 TAGI 100 tablets $0.124 AB1 Discontinued —
Neurontin 800 mg 00071-0401-24 Parke-Davis 100 tablets $16.978 AB1 Discontinued —
Neurontin 800 mg 58151-0285-01 Viatris 100 tablets $16.978 AB1 Availability likely —
Gabapentin 800 mg 42385-0980-01 Laurus 100 tablets — AB1 FDA listed —
Gabapentin 800 mg 43063-0611-90 PD-Rx 90 tablets — AB1 FDA listed —
Gabapentin 800 mg 50090-6189-00 A-S 60 tablets — AB1 FDA listed —
Gabapentin 800 mg 50090-7400-00 A-S 60 tablets — AB1 FDA listed —
Gabapentin 800 mg 55154-3366-00 Cardinal 1 tablet — AB1 FDA listed —
Gabapentin 800 mg 55154-8193-00 Cardinal 1 tablet — AB1 FDA listed —
Gabapentin 800 mg 58118-1167-08 Clinical 30 tablets — AB1 FDA listed —
Gabapentin 800 mg 60760-0517-60 St. 60 tablets — AB1 Discontinued —
Gabapentin 800 mg 60760-0837-60 ST. 60 tablets — AB1 FDA listed —
Gabapentin 800 mg 63187-0010-30 Proficient 30 tablets — AB1 FDA listed —
Gabapentin 800 mg 63187-0148-90 Proficient 90 tablets — AB1 FDA listed —
Gabapentin 800 mg 63629-7308-01 Bryant 90 tablets — AB1 Discontinued —
Gabapentin 800 mg 63629-8489-01 Bryant 500 tablets — AB1 FDA listed —
Gabapentin 800 mg 63629-8490-01 Bryant 100 tablets — AB1 FDA listed —
Gabapentin 800 mg 65841-0706-01 Zydus 100 tablets — AB1 FDA listed —
Gabapentin 800 mg 67046-1536-03 Coupler 30 tablets — AB1 FDA listed —
Gabapentin 800 mg 67046-1667-03 Coupler 30 tablets — AB1 FDA listed —
Gabapentin 800 mg 68071-2206-01 NuCare 100 tablets — AB1 FDA listed —
Gabapentin 800 mg 68071-2214-09 NuCare 90 tablets — AB1 FDA listed —
Gabapentin 800 mg 68071-3523-09 NuCare 90 tablets — AB1 FDA listed —
Gabapentin 800 mg 68788-7757-01 Preferred 100 tablets — AB1 FDA listed —
Gabapentin 800 mg 68788-7774-01 Preferred 100 tablets — AB1 FDA listed —
Gabapentin 800 mg 68788-8468-01 Preferred 100 tablets — AB1 FDA listed —
Gabapentin 800 mg 68788-8790-01 Preferred 100 tablets — AB1 FDA listed —
Gabapentin 800 mg 69097-0811-02 Cipla 30 tablets — — FDA listed —
Gabapentin 800 mg 70518-2323-00 REMEDYREPACK 30 tablets — AB1 FDA listed —
Gabapentin 800 mg 70518-2912-00 REMEDYREPACK 100 tablets — AB1 Discontinued —
Gabapentin 800 mg 71205-0160-30 Proficient 30 tablets — AB1 FDA listed —
Gabapentin 800 mg 71205-0514-30 Proficient 30 tablets — AB1 FDA listed —
Gabapentin 800 mg 71205-0774-30 Proficient 30 tablets — AB1 FDA listed —
Gabapentin 800 mg 71205-0932-00 Proficient 100 tablets — AB1 FDA listed —
Gabapentin 800 mg 71335-0254-01 Bryant 30 tablets — AB1 FDA listed —
Gabapentin 800 mg 71335-1007-01 Bryant 30 tablets — AB1 FDA listed —
Gabapentin 800 mg 71335-1041-01 Bryant 90 tablets — AB1 FDA listed —
Gabapentin 800 mg 71335-2037-01 Bryant 30 tablets — AB1 FDA listed —
Gabapentin 800 mg 71335-2038-01 Bryant 90 tablets — AB1 FDA listed —
Gabapentin 800 mg 71335-2765-01 Bryant 30 tablets — AB1 FDA listed —
Gabapentin 800 mg 71335-2819-01 Bryant 90 tablets — AB1 FDA listed —
Gabapentin 800 mg 71335-3057-01 Bryant 30 tablets — AB1 FDA listed —
Gabapentin 800 mg 71610-0426-60 Aphena 90 tablets — AB1 FDA listed —
Gabapentin 800 mg 71610-0630-30 Aphena 30 tablets — AB1 FDA listed —
Gabapentin 800 mg 71610-0737-30 Aphena 30 tablets — AB1 FDA listed —
Gabapentin 800 mg 71610-0778-45 Aphena 45 tablets — AB1 FDA listed —
Gabapentin 800 mg 72162-1531-01 Bryant 100 tablets — AB1 FDA listed —
Gabapentin 800 mg 72162-2142-01 Bryant 100 tablets — AB1 FDA listed —
Gabapentin 800 mg 72189-0092-90 DIRECT 90 tablets — AB1 FDA listed —
Gabapentin 800 mg 72189-0158-30 DIRECT 30 tablets — AB1 FDA listed —
Gabapentin 800 mg 72189-0178-30 DIRECT 30 tablets — AB1 FDA listed —
Gabapentin 800 mg 72189-0394-72 Direct_Rx 120 tablets — AB1 FDA listed —
Gabapentin 800 mg 72189-0619-72 Direct_Rx 120 tablets — AB1 FDA listed —
Gabapentin 800 mg 72789-0217-60 PD-Rx 60 tablets — AB1 FDA listed —
Gabapentin 800 mg 72865-0256-05 XLCare 500 tablets — AB1 FDA listed —
Gabapentin 800 mg 72888-0132-00 Advagen 1000 tablets — AB1 FDA listed —
Gabapentin 800 mg 76420-0497-01 Asclemed 100 tablets — AB1 FDA listed —
Gabapentin 800 mg 76420-0837-01 Asclemed 100 tablets — AB1 FDA listed —
Gabapentin 800 mg 77771-0178-05 Radha 500 tablets — AB1 FDA listed —
Gabapentin 800 mg 80425-0035-01 Advanced 30 tablets — AB1 FDA listed —
Gabapentin 800 mg 80425-0036-01 Advanced 30 tablets — AB1 FDA listed —
Gabapentin 800 mg 80425-0158-01 Advanced 30 tablets — AB1 FDA listed —
Gabapentin 800 mgthis 80425-0204-04 Advanced 120 tablets — AB1 FDA listed —
Gabapentin 800 mg 82619-0146-01 Creekwood 100 tablets — AB1 FDA listed —
Gabapentin 800 mg 82804-0203-30 Proficient 30 tablets — AB1 FDA listed —
Gabapentin 800 mg 82804-0249-90 Proficient 90 tablets — AB1 FDA listed —
Gabapentin 800 mg 85534-0010-00 HAWAII 30 tablets — AB1 FDA listed —
Gabapentin 800 mg 71335-1601-01 Bryant 30 tablets — AB1 FDA listed —
Gabapentin 800 mg 68071-5310-09 NuCare 90 tablets — AB1 FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2022
On the market since
Oct 2022
📍
2026
Currently FDA-listed
4 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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

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

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Gabapentin — the program that covers self-administered drugs. 41 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Gabapentin. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$151.2M
Claims incl. refills
8.9M
Beneficiaries
5.1M
Spend / beneficiary
$29.73
Spend / claim
$16.90
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

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

Top reported reactions

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

Reporter sex

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

Serious outcomes

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

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
80425-0204-01 30 TABLET, COATED in 1 BOTTLE (80425-0204-1) 2023-11-01 Active
80425-0204-02 60 TABLET, COATED in 1 BOTTLE (80425-0204-2) 2023-11-01 Active
80425-0204-03 90 TABLET, COATED in 1 BOTTLE (80425-0204-3) 2023-11-01 Active
80425-0204-04 You're viewing this 120 TABLET, COATED in 1 BOTTLE (80425-0204-4) 2023-11-01 Active

You're viewing the largest of 4 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 80425-0204-04?
NDC 80425-0204-04 is a 120-count package — 120 tablet, coated in 1 bottle.
What is the difference between NDC 80425-0204-04 and NDC 80425-0204-01?
Both are Gabapentin 800 mg Tablet, Coated — the drug itself is identical. NDC 80425-0204-04 is the 120-count package, while NDC 80425-0204-01 is the 30 tablets package.
What NDC number is used to bill for this package of Gabapentin 800 mg Tablet, Coated?
Bill NDC 80425-0204-04 — the 11-digit billing format is 80425020404. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 80425-0204-4, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 80425-0204-04, written without dashes as 80425020404. 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 80425-0204-04, the first segment (80425) is the labeler code FDA assigned to Advanced Rx of Tennessee, LLC; the middle segment (0204) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Advanced Rx of Tennessee, LLC. 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 3 other package presentations of this same product, including 30 tablets (80425-0204-01), 60 tablets (80425-0204-02), 90 tablets (80425-0204-03). 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?
Advanced Rx of Tennessee, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Medication Guide
🎯 Indications and Usage 39 words ▾

1. Indications and Usage Gabapentin is indicated for: Management of postherpetic neuralgia in adults Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy

⏱️ Dosage and Administration ~3 min read ▾

2. Dosage and Administration

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

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

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

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

Gabapentin may be administered as 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.

2.3Dosage Adjustment in Patients with Renal Impairment Dosage adjustment in patients 12 years of age and older with renal impairment or undergoing hemodialysis is recommended, as follows (see dosing recommendations above for effective doses in each indication): TABLE 1. Gabapentin Dosage Based on Renal Function Renal Function Creatinine Clearance (mL/min) Total Daily Dose Range (mg/day) Dosage Regimen (mg) ≥ 60 900 to 3,600 300 TID 400 TID 600 TID 800 TID 1,200 TID > 30 to 59 400 to 1,400 200 BID 300 BID 400 BID 500 BID 700 BID > 15 to 29 200 to 700 200 QD 300 QD 400 QD 500 QD 700 QD 15 * 100 to 300 100 QD 125 QD 150 QD 200 QD 300 QD Post-Hemodialysis Supplemental Dose (mg) † Hemodialysis 125† 150 † 200† 250 † 350 † TID = Three times a day; BID = Two times a day; QD = Single daily dose * 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). † Patients on hemodialysis should receive maintenance doses based on estimates of creatinine clearance as indicated in the upper portion of the table and a supplemental post-hemodialysis dose administered after each 4 hours of hemodialysis as indicated in the lower portion of the table.

Creatinine clearance (CLCr) is difficult to measure in outpatients. In patients with stable renal function, creatinine clearance can be reasonably well estimated using the equation of Cockcroft and Gault: CLCr =[140 − age (years) ] × weight (kg)( × 0.85 for female patients)72 × serum creatinine (mg/dL) The use of gabapentin in patients less than 12 years of age with compromised renal function has not been studied.

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

💊 Dosage Forms and Strengths 49 words ▾

3. Dosage Forms and Strengths Gabapentin Tablets USP, 600 mg are white, elliptical, film-coated scored tablets debossed "O|E" on one side and "600" on the other side Gabapentin Tablets USP, 800 mg are white, elliptical, film-coated scored tablets debossed "O|E" on one side and "800" on the other side

⛔ Contraindications 17 words ▾

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

⚠️ Warnings and Cautions ~3 min read ▾

5. Warnings and Precautions

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

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

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

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

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

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

5.4Somnolence/Sedation and Dizziness During the controlled epilepsy trials in patients older than 12 years of age receiving doses of gabapentin up to 1,800 mg daily, somnolence, dizziness, and ataxia were reported at a greater rate in patients receiving gabapentin compared to placebo: i.e., 19% in drug versus 9% in placebo for somnolence, 17% in drug versus 7% in placebo for dizziness, and 13% in drug versus 6% in placebo for ataxia. In these trials somnolence, ataxia and fatigue were common adverse reactions leading to discontinuation of gabapentin in patients older than 12 years of age, with 1.2%, 0.8% and 0.6% discontinuing for these events, respectively.

During the controlled trials in patients with post-herpetic neuralgia, somnolence, and dizziness were reported at a greater rate compared to placebo in patients receiving gabapentin, in dosages up to 3,600 mg per day: i.e., 21% in gabapentin-treated patients versus 5% in placebo-treated patients for somnolence and 28% in gabapentin-treated patients versus 8% in placebo-treated patients for dizziness. Dizziness and somnolence were among the most common adverse reactions leading to discontinuation of gabapentin. Patients should be carefully observed for signs of central nervous system (CNS) depression, such as somnolence and sedation, when gabapentin is used with other drugs with sedative properties b…

🤒 Adverse Reactions ~3 min read ▾

6. Adverse Reactions The following serious adverse reactions are discussed in greater detail in other sections: Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity [see WARNINGS AND PRECAUTIONS (5.1)] Anaphylaxis and Angioedema [see WARNINGS AND PRECAUTIONS (5.2)] Somnolence/Sedation and Dizziness [see WARNINGS AND PRECAUTIONS (5.4)] Withdrawal Precipitated Seizure, Status Epilepticus [see WARNINGS AND PRECAUTIONS (5.5)] Suicidal Behavior and Ideation [see WARNINGS AND PRECAUTIONS (5.6)] Respiratory Depression [see WARNINGS AND PRECAUTIONS (5.7)] Neuropsychiatric Adverse Reactions (Pediatric Patients 3 to 12 Years of Age) [see WARNINGS AND PRECAUTIONS (5.8)] Sudden and Unexplained Death in Patients with Epilepsy [see WARNINGS AND PRECAUTIONS (5.10)]

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Postherpetic Neuralgia The most common adverse reactions associated with the use of gabapentin in adults, not seen at an equivalent frequency among placebo-treated patients, were dizziness, somnolence, and peripheral edema. In the 2 controlled trials in postherpetic neuralgia, 16% of the 336 patients who received gabapentin and 9% of the 227 patients who received placebo discontinued treatment because of an adverse reaction.

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

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

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

The most common adverse reactions with gabapentin in combination with other antiepileptic drugs in pediatric 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 AND PRECAUTIONS (5.8)]. Approximately 7% of the 2,074 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 reaction.

The adverse reactions most commonly associated with withdrawal in patients > 12 years of age were somnolence (…

🔄 Drug Interactions 210 words ▾

7. Drug Interactions

7.1Opioids Respiratory depression and sedation, sometimes resulting in death, have been reported following coadministration of gabapentin with opioids (e.g., morphine, hydrocodone, oxycodone, buprenorphine) [see WARNINGS AND PRECAUTIONS (5.7)]. Hydrocodone Coadministration of gabapentin with hydrocodone decreases hydrocodone exposure [see CLINICAL PHARMACOLOGY (12.3)]. The potential for alteration in hydrocodone exposure and effect should be considered when gabapentin is started or discontinued in a patient taking hydrocodone.

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

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

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

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

👥 Use in Specific Populations ~3 min read ▾

8. Use in Specific Populations

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as gabapentin, during pregnancy. Encourage women who are taking gabapentin during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling the toll free number 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/. Risk Summary There are no adequate data on the developmental risks associated with the use of gabapentin in pregnant women.

In nonclinical studies in mice, rats, and rabbits, gabapentin was developmentally toxic (increased fetal skeletal and visceral abnormalities, and increased embryofetal mortality) when administered to pregnant animals at doses similar to or lower than those used clinically [see DATA]. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown.

Data Animal data When pregnant mice received oral doses of gabapentin (500, 1,000, or 3,000 mg/kg/day) during the period of organogenesis, embryofetal toxicity (increased incidences of skeletal variations) was observed at the two highest doses. The no-effect dose for embryofetal developmental toxicity in mice (500 mg/kg/day) is less than the maximum recommended human dose (MRHD) of 3,600 mg on a body surface area (mg/m2) basis. In studies in which rats received oral doses of gabapentin (500 to 2,000 mg/kg/day) during pregnancy, adverse effect on offspring development (increased incidences of hydroureter and/or hydronephrosis) were observed at all doses.

The lowest dose tested is similar to the MRHD on a mg/m2 basis. When pregnant rabbits were treated with gabapentin during the period of organogenesis, an increase in embryofetal mortality was observed at all doses tested (60, 300, or 1,500 mg/kg). The lowest dose tested is less than the MRHD on a mg/m2 basis.

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

The clinical significance of these findings is unknown.

8.2Lactation Risk Summary Gabapentin is secreted in human milk following oral administration. The effects on the breastfed infant and on milk production are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for gabapentin and any potential adverse effects on the breastfed infant from gabapentin or from the underlying maternal condition.

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

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

🆘 Overdosage 74 words ▾

10. Overdosage Signs of acute toxicity in animals included ataxia, labored breathing, ptosis, sedation, hypoactivity, or excitation. Acute oral overdoses of gabapentin have been reported.

Symptoms have included double vision, tremor, slurred speech, drowsiness, altered mental status, dizziness, lethargy, and diarrhea. Fatal respiratory depression has been reported with gabapentin overdose, alone and in combination with other CNS depressants. Gabapentin can be removed by hemodialysis.

If overexposure occurs, call your poison control center at 1-800-222-1222.

🧬 Clinical Pharmacology ~3 min read ▾

12. Clinical Pharmacology

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

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

Food has only a slight effect on the rate and extent of absorption of gabapentin (14% increase in AUC and 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 5 to 7 hours and is unaltered by dose or following multiple dosing. Gabapentin elimination rate constant, plasma clearance, and renal clearance are directly proportional to creatinine clearance. In elderly patients, and in patients with impaired renal function, gabapentin plasma clearance is reduced.

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

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

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

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

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

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

📦 How Supplied / Storage and Handling 121 words ▾

16. How Supplied/Storage and Handling Gabapentin tablets, USP are supplied as follows: 600 mg tablets: White, elliptical, film-coated scored tablets debossed "O|E" on one side and "600" on the other side; available in: Bottles of 30 tablets NDC: 80425-0201-01 Bottles of 60 tablets NDC: 80425-0201-02 Bottles of 90 tablets NDC: 80425-0201-03 Bottles of 120 tablets NDC: 80425-0201-04 800 mg tablets: White, elliptical, film-coated scored tablets debossed "O|E" on one side and "800" on the other side; available in: Bottles of 30 tablets NDC: 80425-0204-01 Bottles of 60 tablets NDC: 80425-0204-02 Bottles of 90 tablets NDC: 80425-0204-03 Bottles of 120 tablets NDC: 80425-0204-04 Storage Store at 25°C (77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

📋 Description 113 words ▾

11. Description The active ingredient in gabapentin tablets, USP is gabapentin, which has the chemical name 1-(aminomethyl) cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24.

The structural formula of gabapentin is: Gabapentin is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25.

Each gabapentin tablet, USP contains 600 mg or 800 mg of gabapentin and the following inactive ingredients: copovidone, corn starch, macrogol, magnesium stearate, polyvinyl alcohol, talc and titanium dioxide. Description

💬 Medication Guide ~3 min read ▾

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

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

Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: • thoughts about suicide or dying • attempts to commit suicide • new or worse depression • new or worse anxiety • feeling agitated or restless • panic attacks • trouble sleeping (insomnia) • new or worse irritability • acting aggressive, being angry, or violent • acting on dangerous impulses • an extreme increase in activity and talking (mania) • other unusual changes in behavior or mood How can I watch for early symptoms of suicidal thoughts and actions? • Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. • Keep all follow-up visits with your healthcare provider as scheduled.

Call your healthcare provider between visits as needed, especially if you are worried about symptoms. Do not stop taking gabapentin tablets without first talking to a healthcare provider. • Stopping gabapentin tablets suddenly can cause serious problems. Stopping a seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus). • Suicidal thoughts or actions can be caused by things other than medicines.

If you have suicidal thoughts or actions, your healthcare provider may check for other causes. 2. Changes in behavior and thinking - Using gabapentin tablets in children 3 to 12 years of age can cause emotional changes, aggressive behavior, problems with concentration, restlessness, changes in school performance, and hyperactivity.

3. Gabapentin tablets may cause serious or life-threatening allergic reactions that may affect your skin or other parts of your body such as your liver or blood cells. This may cause you to be hospitalized or to stop gabapentin tablets.

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

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

Serious breathing problems can occur when gabapentin tablets is 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.

What are gabapentin tablets? Gabapentin tablets are a prescription medicine used to treat: • Pain from damaged nerves (postherpetic pain) that follows healing of shingles (a painful rash that comes after a herpes zoster infection) in adults. • Partial seizures when taken together with other medicines in adults and children 3 years of age and older with seizures. Who should not take gabapentin tablets?

Do not take gabapentin tablets if you are allergic to gabapentin or any of the other 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…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.