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(from DailyMed)

Gabapentin 800 mg Tablet, 60-count

by Proficient Rx LP · 60 TABLET in 1 BOTTLE (63187-010-60)
NDC 63187-0010-60
🏷️ FDA NDC (as labeled) 63187-010-60 billing pads the product segment with a zero
This package
Contains60-count Pack sizes3 compare ↓
Also priced by: Part D plans $0.1683/unit — full pricing hub ↓
Also comes in: 30 tablets 63187-0010-30 90 tablets 63187-0010-90
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) 63187-010-60
Product NDC 63187-010
11-digit billing NDC 63187001060
NCPDP billing unit EA — each (per item)
RxCUI 310433, 310434
UNII 6CW7F3G59X
Application # ANDA077662
SPL Set ID c78f528f-9192-4037-bfb9-ff5718ed26c5
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 2006-04-01
Route ORAL
Dosage form TABLET
Substance GABAPENTIN
GPI-14 72600030000340
GPI class Gabapentin
GCN Seq No 041806
GCN 94447
HICL code 008831
Ingredient (HICL) Gabapentin
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H4
Therapeutic class — intermediate (HIC2) Anticonvulsants
HIC3 code H4B
Therapeutic class — specific (HIC3) Anticonvulsants
AHFS code 28:08.92.00
AHFS class Analgesics And Antipyretics, Misc.
FDB label name GABAPENTIN 800 MG TABLET
FDB brand name Gabapentin
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB1 · RLD · RS
Why two NDCs? The FDA registers this code as 63187-010-60 — 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 → 63187-0010-60. 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

LabelerProficient Rx LP
Application holderGLENMARK PHARMACEUTICALS LTD
FDA applicationANDA077662 (ANDA)
Labeler code63187
First marketedApr 2006
Product typeHuman Prescription Drug
Portfolio1,723 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name GABAPENTIN 800 MG TABLET Ingredient Gabapentin
📖 What it is MedlinePlus · NLM

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

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

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

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

🧪 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 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 TUF2IVW3M2
    Poloxamer 407 is a synthetic polymer made from ethylene oxide and propylene oxide. In medicines, it acts as a thickener, emulsifier, and solubilizer to help mix ingredients and create the right texture.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

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

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

Inactive ingredient FAQ

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

💲 Pricing

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

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.1683 $10.10 / 60 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 mgthis 63187-0010-60 Proficient 60 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 mg 80425-0204-01 Advanced 30 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 —
Gabapentin 800 mg 58118-2127-08 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

🏛️
2006
On the market since
Apr 2006
📍
2026
Currently FDA-listed
20 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
63187-0010-30 30 TABLET in 1 BOTTLE (63187-010-30) 2016-12-01 Active
63187-0010-60 You're viewing this 60 TABLET in 1 BOTTLE (63187-010-60) 2014-04-01 Active
63187-0010-90 90 TABLET in 1 BOTTLE (63187-010-90) 2014-04-01 Active

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

Pack size FAQ

What quantity is in NDC 63187-0010-60?
NDC 63187-0010-60 is a 60-count package — 60 tablet in 1 bottle.
What is the difference between NDC 63187-0010-60 and NDC 63187-0010-30?
Both are Gabapentin 800 mg Tablet — the drug itself is identical. NDC 63187-0010-60 is the 60-count package, while NDC 63187-0010-30 is the 30 tablets package.
What NDC number is used to bill for this package of Gabapentin 800 mg Tablet?
Bill NDC 63187-0010-60 — the 11-digit billing format is 63187001060. 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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 63187-010-60, 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: 63187-0010-60, written without dashes as 63187001060. 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 63187-0010-60, the first segment (63187) is the labeler code FDA assigned to Proficient Rx LP; the middle segment (0010) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (60) 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 Proficient Rx LP. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 30 tablets (63187-0010-30), 90 tablets (63187-0010-90). 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?
Proficient Rx LP is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🔄 Drug / Laboratory Test Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🎯 Indications and Usage 70 words ▾

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

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND ADMINISTRATION Gabapentin tablets USP are given orally with or without food. Patients should be informed that, should they break the scored 600 or 800 mg tablet in order to administer a half-tablet, they should take the unused half-tablet as the next dose. Half-tablets not used within several days of breaking the scored tablet should be discarded.

If gabapentin tablets USP dose is reduced, discontinued or substituted with an alternative medication, this should be done gradually over a minimum of 1 week (a longer period may be needed at the discretion of the prescriber). Postherpetic Neuralgia In adults with postherpetic neuralgia, gabapentin tablets USP therapy may be initiated as a single 300 mg dose on Day 1, 600 mg/day on Day 2 (divided BID), and 900 mg/day on Day 3 (divided TID). The dose can subsequently be titrated up as needed for pain relief to a daily dose of 1800 mg (divided TID).

In clinical studies, efficacy was demonstrated over a range of doses from 1800 mg/day to 3600 mg/day with comparable effects across the dose range. Additional benefit of using doses greater than 1800 mg/day was not demonstrated. Epilepsy Gabapentin tablets USP are recommended for add-on therapy in patients 3 years of age and older.

Effectiveness in pediatric patients below the age of 3 years has not been established. Patients >12 years of age: The effective dose of gabapentin tablets USP is 900 to 1800 mg/day and given in divided doses (three times a day) using 600 or 800 mg tablets. The starting dose is 300 mg three times a day.

If necessary, the dose may be increased using 600 or 800 mg tablets three times a day up to 1800 mg/day. Dosages up to 2400 mg/day have been well tolerated in long-term clinical studies. Doses of 3600 mg/day have also been administered to a small number of patients for a relatively short duration, and have been well tolerated.

The maximum time between doses in the TID schedule should not exceed 12 hours. Pediatric Patients Age 3–12 years: The starting dose should range from 10-15 mg/kg/day in 3 divided doses, and the effective dose reached by upward titration over a period of approximately 3 days. The effective dose of gabapentin tablets USP in patients 5 years of age and older is 25–35 mg/kg/day and given in divided doses (three times a day).

The effective dose in pediatric patients ages 3 and 4 years is 40 mg/kg/day and given in divided doses (three times a day) (see CLINICAL PHARMACOLOGY, Pediatric ). Dosages up to 50 mg/kg/day have been well-tolerated in a long-term clinical study. The maximum time interval between doses should not exceed 12 hours.

It is not necessary to monitor gabapentin plasma concentrations to optimize gabapentin tablets USP therapy. Further, because there are no significant pharmacokinetic interactions among gabapentin tablets USP and other commonly used antiepileptic drugs, the addition of gabapentin tablets USP does not alter the plasma levels of these drugs appreciably. If gabapentin tablets USP are discontinued and/or an alternate anticonvulsant medication is added to the therapy, this should be done gradually over a minimum of 1 week.

Dosage in Renal Impairment Creatinine clearance is difficult to measure in outpatients. In patients with stable renal function, creatinine clearance (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 )] in which age is in years, weight is in kilograms and SCr is serum creatinine in mg/dL. Dosage adjustment in patients ≥12 years of age with compromised renal function or undergoing hemodialysis is recommended as follows (see dosing recommendations above for effective doses in each indication).

TABLE 6. Gabapentin Tablets USP Dosage Based on Renal Function Renal Function Creatinine Clearance (mL/min) Total Daily Dose Range (mg/day) Dose Regimen (mg) ≥60 900-3600 300 TID 400 TID 600 TID 800 TID 1200 TID >30-59 400-1…

⛔ Contraindications 17 words ▾

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

⚠️ Warnings ~3 min read ▾

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

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

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

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

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

2.4Psychiatric 5.7 8.5 1.5

2.9Other 1.0 1.8 1.9

0.9Total 2.4 4.3 1.8

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

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

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

🤒 Adverse Reactions ~3 min read ▾

ADVERSE REACTIONS Postherpetic Neuralgia The most commonly observed adverse events associated with the use of gabapentin in adults, not seen at an equivalent frequency among placebo-treated patients, were dizziness, somnolence, and peripheral edema. In the 2 controlled studies in postherpetic neuralgia, 16% of the 336 patients who received gabapentin and 9% of the 227 patients who received placebo discontinued treatment because of an adverse event. The adverse events that most frequently led to withdrawal in gabapentin-treated patients were dizziness, somnolence, and nausea.

Incidence in Controlled Clinical Trials TABLE 3 lists treatment-emergent signs and symptoms that occurred in at least 1% of gabapentin-treated patients with postherpetic neuralgia participating in placebo-controlled trials and that were numerically more frequent in the gabapentin group than in the placebo group. Adverse events were usually mild to moderate in intensity. TABLE 3.

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

4.8Infection 5.1

3.5Headache 3.3

3.1Accidental injury 3.3

1.3Abdominal pain 2.7

2.6Digestive System Diarrhea 5.7

3.1Dry mouth 4.8

1.3Constipation 3.9

1.8Nausea 3.9

3.1Vomiting 3.3

1.8Flatulence 2.1

1.8Metabolic and Nutritional Disorders Peripheral edema 8.3

2.2Weight gain 1.8

0.0Hyperglycemia 1.2

0.4Nervous System Dizziness 28.0

7.5Somnolence 21.4

5.3Ataxia 3.3

0.0Thinking abnormal 2.7

0.0Abnormal gait 1.5

0.0Incoordination 1.5

0.0Amnesia 1.2

0.9Hypesthesia 1.2

0.9Respiratory System Pharyngitis 1.2

0.4Skin and Appendages Rash 1.2

0.9Special Senses Amblyopia Reported as blurred vision 2.7

0.9Conjunctivitis 1.2

0.0Diplopia 1.2

0.0Otitis media 1.2

0.0Other events in more than 1% of patients but equally or more frequent in the placebo group included pain, tremor, neuralgia, back pain, dyspepsia, dyspnea, and flu syndrome. There were no clinically important differences between men and women in the types and incidence of adverse events. Because there were few patients whose race was reported as other than white, there are insufficient data to support a statement regarding the distribution of adverse events by race.

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

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

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

🔄 Drug Interactions ~3 min read ▾

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 µg/mL; 1 mM) was a slight degree of inhibition (14%-30%) of isoform CYP2A6 observed. No inhibition of any of the other isoforms tested was observed at gabapentin concentrations up to 171 µg/mL (approximately 15 times the C max at 3600 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. Phenytoin: In a single (400 mg) and multiple dose (400 mg TID) study of gabapentin 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.

Carbamazepine: Steady-state trough plasma carbamazepine and carbamazepine 10, 11 epoxide concentrations were not affected by concomitant gabapentin (400 mg TID; N=12) administration. Likewise, gabapentin pharmacokinetics were unaltered by carbamazepine administration. Valproic Acid: The mean steady-state trough serum valproic acid concentrations prior to and during concomitant gabapentin administration (400 mg TID; N=17) were not different and neither were gabapentin pharmacokinetic parameters affected by valproic acid.

Phenobarbital: Estimates of steady-state pharmacokinetic parameters for phenobarbital or gabapentin (300 mg TID; N=12) are identical whether the drugs are administered alone or together. Naproxen: Coadministration (N=18) of naproxen sodium capsules (250 mg) with gabapentin (125 mg) appears to increase the amount of gabapentin absorbed by 12% to 15%. Gabapentin had no effect on naproxen pharmacokinetic parameters.

These doses are lower than the therapeutic doses for both drugs. The magnitude of interaction within the recommended dose ranges of either drug is not known. Hydrocodone: Coadministration of gabapentin (125 to 500 mg;N=48) decreases hydrocodone (10 mg; N=50) C max and AUC values in a dose-dependent manner relative to administration of hydrocodone alone; C max and AUC values are 3% to 4% lower, respectively, after administration of 125 mg gabapentin and 21% to 22% lower, respectively, after administration of 500 mg gabapentin.

The mechanism for this interaction is unknown. Hydrocodone increases gabapentin AUC values by 14%. The magnitude of interaction at other doses is not known.

Morphine: A literature article reported that when a 60-mg controlled-release morphine capsule was administered 2 hours prior to a 600-mg gabapentin capsule (N=12), mean gabapentin AUC increased by 44% compared to gabapentin administered without morphine (see PRECAUTIONS ). Morphine pharmacokinetic parameter values were not affected by administration of gabapentin 2 hours after morphine. The magnitude of interaction at other doses is not known.

Cimetidine: In the presence of cimetidine at 300 mg QID (N=12) the mean apparent oral clearance of gabapentin fell by 14% and creatinine clearance fell by 10%. Thus cimetidine appeared to alter the renal excretion of both gabapentin and creatinine, an endogenous marker of renal function. This small decrease in excretion of gabapentin by cimetidine is not expected to be of clinical importance.

The effect of gabapentin on cimetidine was not evaluated. Oral Contraceptive: Based on AUC and half-life, multiple-dose pharmacokinetic profiles of norethindrone and ethinyl estradiol following administration of tablets containing 2.5 mg of norethindrone acetate and 50 mcg of ethinyl estradiol were similar with and wit…

🔄 Drug / Laboratory Test Interactions 44 words ▾

Drug/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.

🤰 Pregnancy ~2 min read ▾

Pregnancy Pregnancy Category C: Gabapentin has been shown to be fetotoxic in rodents, causing delayed ossification of several bones in the skull, vertebrae, forelimbs, and hindlimbs. These effects occurred when pregnant mice received oral doses of 1000 or 3000 mg/kg/day during the period of organogenesis, or approximately 1 to 4 times the maximum dose of 3600 mg/day given to epileptic patients on a mg/m 2 basis. The no-effect level was 500 mg/kg/day or approximately ½ of the human dose on a mg/m 2 basis.

When rats were dosed prior to and during mating, and throughout gestation, pups from all dose groups (500, 1000 and 2000 mg/kg/day) were affected. These doses are equivalent to less than approximately 1 to 5 times the maximum human dose 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 2000 mg/kg/day with no effect at 1000 mg/kg/day, in a teratology study at 1500 mg/kg/day with no effect at 300 mg/kg/day, and in a perinatal and postnatal study at all doses studied (500, 1000 and 2000 mg/kg/day).

The doses at which the effects occurred are approximately 1 to 5 times the maximum human dose of 3600 mg/day on a mg/m 2 basis; the no-effect doses were approximately 3 times (Fertility and General Reproductive Performance study) and approximately equal to (Teratogenicity study) the maximum human dose 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 controls in offspring of mice, rats, or rabbits given doses up to 50 times (mice), 30 times (rats), and 25 times (rabbits) the human daily dose on a mg/kg basis, or 4 times (mice), 5 times (rats), or 8 times (rabbits) the human daily dose on a mg/m 2 basis.

In a teratology study in rabbits, an increased incidence of postimplantation fetal loss occurred in dams exposed to 60, 300, and 1500 mg/kg/day, or less than approximately ¼ to 8 times the maximum human dose on a mg/m 2 basis. There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

To provide information regarding the effects of in utero exposure to gabapentin, physicians are advised to recommend that pregnant patients taking gabapentin enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves. Information on the registry can also be found at the website http://www.aedpregnancyregistry.org/.

🧒 Pediatric Use 49 words ▾

Pediatric Use Safety and effectiveness of gabapentin in the management of postherpetic neuralgia in pediatric patients have not been established. 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 PHARMACOLOGY, Clinical Studies ).

🧓 Geriatric Use ~1 min read ▾

Geriatric 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 with younger patients who received the same dosage. Since gabapentin is almost exclusively eliminated by renal excretion, the larger treatment effect observed in patients ≥75 years may be a consequence of increased gabapentin exposure for a given dose that results from an age-related decrease in renal function.

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

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

Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and dose should be adjusted based on creatinine clearance values in these patients (see CLINICAL PHARMACOLOGY , ADVERSE REACTIONS , and DOSAGE AND ADMINISTRATION ).

🆘 Overdosage 102 words ▾

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

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

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

🧬 Clinical Pharmacology ~3 min read ▾

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

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

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

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

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

However, functional correlates of gabapentin binding, if any, remain to be elucidated. Pharmacokinetics and Drug Metabolism All pharmacological actions following gabapentin administration are due to the activity of the parent compound; gabapentin is not appreciably metabolized in humans. Oral Bioavailability: Gabapentin bioavailability is not dose proportional; i.e., as dose is increased, bioavailability decreases.

Bioavailability of gabapentin is approximately 60%, 47%, 34%, 33%, and 27% following 900, 1200, 2400, 3600, and 4800 mg/day given in 3 divided doses, respectively. Food has only a slight effect on the rate and extent of absorption of gabapentin (14% increase in AUC and C max ). Distribution: Less than 3% of gabapentin circulates bound to plasma protein.

The apparent volume of distribution of gabapentin after 150 mg intravenous administration is 58±6 L (mean ±SD). In patients with epilepsy, steady-state predose (C min ) concentrations of gabapentin in cerebrospinal fluid were approximately 20% of the corresponding plasma concentrations. Elimination: Gabapentin is eliminated from the systemic circulation by renal excretion as unchanged drug.

Gabapentin is not appreciably metabolized in humans. Gabapentin elimination half-life is 5…

🧬 Mechanism of Action ~2 min read ▾

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

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

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

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

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

However, functional correlates of gabapentin binding, if any, remain to be elucidated.

📦 How Supplied / Storage and Handling 107 words ▾

HOW SUPPLIED Gabapentin tablets USP, 600 mg: White to off white film-coated, oval shaped, biconvex scored tablets debossed with “G” and “31” on one side. Available in: Bottles of 30: NDC 63187-057-30 Bottles of 60: NDC 63187-057-60 Bottles of 90: NDC 63187-057-90 Bottles of 100 NDC 63187-057-00 Gabapentin tablets USP, 800 mg: White to off white film-coated, oval shaped, biconvex scored tablets debossed with “G” and “13” on one side. Available in: Bottles of 30: NDC 63187-010-30 Bottles of 60: NDC 63187-010-60 Bottles of 90: NDC 63187-010-90 Storage (Tablets) Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

📦 Storage and Handling 20 words ▾

Storage (Tablets) Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

📋 Description 130 words ▾

DESCRIPTION Gabapentin tablets USP are supplied as oval shaped, film-coated, biconvex scored tablets containing 600 mg and 800 mg of gabapentin USP. The inactive ingredients for the tablets are corn starch, copovidone, poloxamer 407, magnesium stearate, polyethylene glycol, talc, hypromellose, titanium dioxide, macrogol, polysorbate 80 and purified water. Gabapentin USP is described as 1-(aminomethyl) cyclohexaneacetic acid with a molecular formula of C 9 H 17 NO 2 and a molecular weight of 171.24.

The structural formula of gabapentin is: Gabapentin USP is a white to off-white crystalline solid with a pK a1 of 3.7 and a pK a2 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. structural formula gabapentin

💬 Information for Patients ~1 min read ▾

Information for Patients Inform patients of the availability of a Medication Guide, and instruct them to read the Medication Guide prior to taking gabapentin. Instruct patients to take gabapentin only as prescribed. Patients, their caregivers, and families should be counseled that AEDs, including gabapentin, may increase the risk of suicidal thoughts and behavior and should be advised 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.

Behaviors of concern should be reported immediately to healthcare providers. Patients should be advised that gabapentin may cause dizziness, somnolence and other symptoms and signs of CNS depression. Accordingly, they should be advised neither to drive a car nor to operate other complex machinery until they have gained sufficient experience on gabapentin to gauge whether or not it affects their mental and/or motor performance adversely.

Patients who require concomitant treatment with morphine may experience increases in gabapentin concentrations. Patients should be carefully observed for signs of CNS depression, such as somnolence, and the dose of gabapentin or morphine should be reduced appropriately (see PRECAUTIONS, Drug Interactions ). Patients should be encouraged to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry if they become pregnant.

This registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll free number 1-888-233-2334 (see PRECAUTIONS, Pregnancy ). Prior to initiation of treatment with gabapentin, the patient should be instructed that a rash or other signs or symptoms of hypersensitivity (such as fever or lymphadenopathy) may herald a serious medical event and that the patient should report any such occurrence to a physician immediately.

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Gabapentin Tablets USP (gab″ a pen′ tin) Read the Medication Guide before you start taking gabapentin 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.

What is the most important information I should know about gabapentin? Do not stop taking gabapentin without first talking to your healthcare provider. Stopping gabapentin suddenly can cause serious problems.

Gabapentin can cause serious side effects including: 1. Like other antiepileptic drugs, gabapentin may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: • thoughts about suicide or dying • attempts to commit suicide • new or worse depression • new or worse anxiety • feeling agitated or restless • panic attacks • trouble sleeping (insomnia) • new or worse irritability • acting aggressive, being angry, or violent • acting on dangerous impulses • an extreme increase in activity and talking (mania) • other unusual changes in behavior or mood How can I watch for early symptoms of suicidal thoughts and actions? • Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. • Keep all follow-up visits with your healthcare provider as scheduled.

Call your healthcare provider between visits as needed, especially if you are worried about symptoms. Do not stop taking gabapentin without first talking to a healthcare provider. • Stopping gabapentin suddenly can cause serious problems. Stopping a seizure medicine suddenly in a 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 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 may cause a serious or life-threatening allergic reaction that may affect your skin or other parts of your body such as your liver or blood cells.

You may or may not have rash when you get this type of reaction. It may cause you to be hospitalized or to stop gabapentin. Call a healthcare provider right away if you have any of the following symptoms: • skin rash • hives • fever • swollen glands that do not go away • swelling of your lip and 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. What is gabapentin? Gabapentin is a prescription medicine used to treat: • Pain from damaged nerves (postherpetic pain) that follows healing of shingles (a painful rash that comes after a herpes zoster infection) in adults. • Partial seizures when taken together with other medicines in adults and children 3 years of age and older.

Who should not take gabapentin? 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 taking gabapentin? Before taking gabapentin, tell your healthcare provider if you: • have or have had kidney problems or are on hemodialysis • have or have had depression, mood problems, or suicidal thoughts or behavior • are pregnant or plan to become pregnant. It is not known if gabapentin can harm your unborn baby.

Tell your healthcare provider right away if you…

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