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Gabapentin 800 mg Tablet, Film Coated, 12,864-count

by Actavis Pharma, Inc. · 12864 TABLET, FILM COATED in 1 CONTAINER (0228-2637-77)
NDC 00228-2637-77
🏷️ FDA NDC (as labeled) 0228-2637-77 billing pads the labeler segment with a zero
This package
Contains12,864-count Pack sizes4 compare ↓
Also comes in: 100 tablets 00228-2637-11 500 tablets 00228-2637-50 10800 tablets 00228-2637-00
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) 0228-2637-77
Product NDC 0228-2637
11-digit billing NDC 00228263777
SPL Set ID 30bb1bd1-25dc-441e-ba1b-104a4550bf13
DEA schedule Non-controlled
Marketing category DRUG FOR FURTHER PROCESSING
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-05-06
Dosage form TABLET, FILM COATED
Substance GABAPENTIN
GPI-14 72600030000340
GPI class Gabapentin
Why two NDCs? The FDA registers this code as 0228-2637-77 — a 4-4-2 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 labeler segment → 00228-2637-77. 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.

🏭 Manufacturer & labeler

LabelerActavis Pharma, Inc.
Labeler code00228
First marketedMay 2015
Product typeDrug For Further Processing
Portfolio324 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.

🧪 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.

We could not link this NDC to a current FDA Structured Product Label. An inactive-ingredient list is therefore not available from this source.
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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 100 tablets 500 tablets 10800 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 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 mgthis 00228-2637-77 Actavis 12864 tablets — — 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: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2015
On the market since
May 2015
📍
2026
Currently FDA-listed
11 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
100 tablets00228-2637-11 1,575 Rx · $23,744
500 tablets00228-2637-50 699 Rx · $7,267
10800 tablets00228-2637-00 No Medicaid data
12864 tablets this page00228-2637-77 No Medicaid data
Drug total (last 4 qtrs): 2,274 Rx · 148,497 units · $31,011 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Gabapentin (matched by generic name) — 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. CMS lists 5 products for this generic; we show the highest-spend one. 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 Per unit Per pack Marketing startStatus
00228-2637-11 100 TABLET, FILM COATED in 1 BOTTLE (0228-2637-11) $0.1235 / ea $12.35 2004-10-04 Discontinued by firm
00228-2637-50 500 TABLET, FILM COATED in 1 BOTTLE (0228-2637-50) $0.1235 / ea $61.77 2004-10-04 Discontinued by firm
00228-2637-00 10800 TABLET, FILM COATED in 1 BAG (0228-2637-00) — — — Active
00228-2637-77 You're viewing this 12864 TABLET, FILM COATED in 1 CONTAINER (0228-2637-77) — — — Active

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

This pack shows little to no recent Medicaid volume — the 100 tablets pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 00228-2637-77?
NDC 00228-2637-77 is a 12,864-count package — 12864 tablet, film coated in 1 container.
What is the difference between NDC 00228-2637-77 and NDC 00228-2637-11?
Both are Gabapentin 800 mg Tablet, Film Coated — the drug itself is identical. NDC 00228-2637-77 is the 12,864-count package, while NDC 00228-2637-11 is the 100 tablets package.
What NDC number is used to bill for this package of Gabapentin 800 mg Tablet, Film Coated?
Bill NDC 00228-2637-77 — the 11-digit billing format is 00228263777. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

🧭 About this NDC listing & data coverage

Listed for further processing / repackaging

What "drug for further processing" means

FDA lists this package under the "drug for further processing" marketing category: Actavis Pharma, Inc. supplies it to other companies for further processing or repackaging (blister cards that are later repackaged or co-packaged are a common example). The units themselves are a finished dosage form — which is why pricing or Medicaid data can still appear — but this exact package code may not be the presentation a retail pharmacy dispenses.

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) — 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 — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Drug For Further Processing". Products approved under an application carry an NDA, ANDA, or BLA number.
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 0228-2637-77, 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: 00228-2637-77, written without dashes as 00228263777. 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 00228-2637-77, the first segment (00228) is the labeler code FDA assigned to Actavis Pharma, Inc.; the middle segment (2637) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (77) 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 Actavis Pharma, Inc.. 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 100 tablets (00228-2637-11), 500 tablets (00228-2637-50), 10800 tablets (00228-2637-00). 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?
Actavis Pharma, Inc. 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.
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 FDA label FDA SPL

The complete FDA label for this product, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
📄 FDA label
📄 FDA label 19 words ▾

No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 00228-2636-11 · Actavis 00228-2778-11 · Actavis →
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.