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Pregabalin 100 mg Capsule, 90-count

by Actavis Pharma, Inc. · 90 CAPSULE in 1 BOTTLE (0228-2859-09)
NDC 00228-2859-09
🏷️ FDA NDC (as labeled) 0228-2859-09 billing pads the labeler segment with a zero
Rx only Generic Discontinued CV ⚠ Discontinued by firm
🗂️ Data synced Mar 13, 2024 · 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 Pregabalin (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class III · May 16, 2024 — Presence of Foreign Tablets/Capsules: Complaint received from a re-packager, American Health Packaging (AHP), where a foreign tablet was discovered in one of the bottles during packaging set up. Tablet identified as pantoprazole tablet 20mg. (Rising Pharma Holding, Inc.) · FDA recall D-0541-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Jan 2024. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 0228-2859-09
Product NDC 0228-2859
11-digit billing NDC 00228285909
NCPDP billing unit EA — each (per item)
Application # ANDA091025
DEA schedule CV
Marketing category ANDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Jan 2024)
Route ORAL
Dosage form CAPSULE
Substance PREGABALIN
GCN Seq No 057802
GCN 23048
HICL code 026470
Ingredient (HICL) Pregabalin
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 28:12.28.00
AHFS class Gaba-Mediated Anticonvulsants
FDB label name PREGABALIN 100 MG CAPSULE
FDB brand name Pregabalin
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 0228-2859-09 — 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 → 00228-2859-09. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerActavis Pharma, Inc.
Application holderACTAVIS ELIZABETH LLC
FDA applicationANDA091025 (ANDA)
Labeler code00228
DEA scheduleCV
Product typeHuman Prescription Drug
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

Label name PREGABALIN 100 MG CAPSULE Ingredient Pregabalin
📗 Our plain-language guide HelloPharmacist
  • Pregabalin is used for a few different conditions depending on which product you're taking. Most commonly it's prescribed for nerve pain — either from diabetes (diabetic peripheral...
  • Yes, dizziness and drowsiness are the most common side effects — and they're the main reason some people end up stopping the medication. They tend to show up shortly after you star...
  • Will pregabalin make me feel dizzy or drowsy?
  • Please don't stop abruptly. Stopping pregabalin suddenly can cause withdrawal symptoms like insomnia, nausea, headache, and anxiety. If you have a seizure disorder, stopping sudden...
📖 Read our full Pregabalin guide →
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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

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

💲 Pricing

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

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.063 $5.65 / 90 capsules
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.
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Apr 2022 Aug 2022 Jan 2024 $0.092 $0.060
▼ Down 12% over the last 14 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Pregabalin 100 mg 00904-7001-61 Major 100 capsules $0.055 AB Availability likely save 13%
Pregabalin 100 mg 31722-0613-05 Camber 500 capsules $0.055 AB Availability likely save 13%
Pregabalin 100 mg 43547-0509-09 Solco 90 capsules $0.055 AB Availability likely save 13%
Pregabalin 100 mg 50228-0648-05 ScieGen 500 capsules $0.055 AB Availability likely save 13%
Pregabalin 100 mg 50268-0500-01 AvPAK 100 capsules $0.055 AB Availability likely save 13%
Pregabalin 100 mg 60687-0506-01 American 100 capsules $0.055 AB Availability likely save 13%
Pregabalin 100 mg 62135-0446-90 Chartwell 90 capsules $0.055 AB Availability likely save 13%
Pregabalin 100 mg 67877-0465-05 Ascend 500 capsules $0.055 AB Availability likely save 13%
Pregabalin 100 mg 69238-1313-09 Amneal 90 capsules $0.055 AB Availability likely save 13%
Pregabalin 100 mg 69367-0327-09 Westminster 90 capsules $0.055 AB Availability likely save 13%
Pregabalin 100 mg 69367-0427-05 Westminster 500 capsules $0.055 AB Availability likely save 13%
Pregabalin 100 mg 72603-0355-01 NorthStar 90 capsules $0.055 AB Availability likely save 13%
Pregabalin 100 mg 27808-0237-01 Tris 90 capsules $0.057 AB FDA listed save 9%
Pregabalin 100 mg 69097-0957-05 Cipla 90 capsules $0.057 AB FDA listed save 9%
Pregabalin 100 mgthis 00228-2859-09 Actavis 90 capsules $0.063 — Discontinued —
Lyrica 100 mg 58151-0239-77 Viatris 90 capsules $9.698 AB Availability likely +15341%
Pregabalin 100 mg 13668-0361-01 Torrent 100 capsules — AB FDA listed —
pregabalin 100 mg 14445-0124-00 Indoco 1000 capsules — AB FDA listed —
Pregabalin 100 mg 25000-0182-07 MARKSANS 90 capsules — AB FDA listed —
Pregablin 100 mg 33342-0168-10 Macleods 90 capsules — — FDA listed —
pregabalin 100 mg 43598-0294-05 Dr.Reddys 500 capsules — AB FDA listed —
Pregabalin 100 mg 46708-0122-10 Alembic 100 capsules — AB FDA listed —
Pregabalin 100 mg 47335-0689-08 Sun 100 capsules — — FDA listed —
Pregabalin 100 mg 50090-6503-00 A-S 60 capsules — AB FDA listed —
Pregabalin 100 mg 50228-0353-10 ScieGen 1000 capsules — AB FDA listed —
Pregabalin 100 mg 51407-0577-90 Golden 90 capsules — AB FDA listed —
Pregabalin 100 mg 55154-4308-00 Cardinal 10 capsules — AB FDA listed —
Pregabalin 100 mg 55700-0773-30 Quality 30 capsules — AB FDA listed —
Pregabalin 100 mg 58118-1465-08 Clinical 30 capsules — AB FDA listed —
Pregabalin 100 mg 60219-1313-09 Amneal 90 capsules — AB FDA listed —
Pregabalin 100 mg 60760-0591-60 St. 60 capsules — AB FDA listed —
Pregabalin 100 mg 60760-0681-30 St. 30 capsules — AB FDA listed —
Pregabalin 100 mg 60760-0753-60 ST. 30 capsules — AB FDA listed —
Pregabalin 100 mg 62332-0122-10 Alembic 100 capsules — AB FDA listed —
Pregabalin 100 mg 63629-8197-01 Bryant 30 capsules — AB Discontinued —
Pregabalin 100 mg 64980-0413-01 Rising 100 capsules — AB FDA listed —
Pregabalin 100 mg 65862-0761-01 Aurobindo 100 capsules — AB FDA listed —
Pregabalin 100 mg 67046-1628-03 Coupler 30 capsules — AB FDA listed —
Pregabalin 100 mg 68788-7523-01 Preferred 100 capsules — AB FDA listed —
Pregabalin 100 mg 68788-8360-01 Preferred 100 capsules — AB FDA listed —
PREGABALIN capsules, CV 100 mg 69097-0681-02 Cipla 30 capsules — — Discontinued —
Pregabalin 100 mg 70518-2745-00 REMEDYREPACK 90 capsules — AB FDA listed —
Pregabalin 100 mg 70518-3643-00 REMEDYREPACK 90 capsules — AB FDA listed —
Pregabalin 100 mg 71205-0323-30 Proficient 30 capsules — AB FDA listed —
Pregabalin 100 mg 71205-0338-30 Proficient 30 capsules — AB FDA listed —
Pregabalin 100 mg 71205-0639-30 Proficient 30 capsules — AB FDA listed —
Pregabalin 100 mg 71205-0872-00 Proficient 100 capsules — AB FDA listed —
Pregabalin 100 mg 71209-0035-04 Cadila 90 capsules — — FDA listed —
Pregabalin 100 mg 71335-1475-01 Bryant 30 capsules — AB Discontinued —
Pregabalin 100 mg 71335-1740-01 Bryant 30 capsules — AB FDA listed —
Pregabalin 100 mg 71335-1789-01 Bryant 30 capsules — AB FDA listed —
Pregabalin 100 mg 71335-2343-01 Bryant 30 capsules — AB FDA listed —
Pregabalin 100 mg 71610-0316-30 Aphena 30 capsules — AB FDA listed —
Pregabalin 100 mg 71610-0808-30 Aphena 30 capsules — AB FDA listed —
Pregabalin 100 mg 71610-0871-30 Aphena 30 capsules — AB FDA listed —
Pregabalin 100 mg 71610-0894-30 Aphena 30 capsules — AB FDA listed —
Pregabalin 100 mg 71610-0936-30 Aphena 30 capsules — AB FDA listed —
Pregabalin 100 mg 71610-0994-30 Aphena 30 capsules — AB FDA listed —
Pregabalin 100 mg 72162-1544-09 Bryant 90 capsules — AB FDA listed —
Pregabalin 100 mg 72189-0033-30 Direct_Rx 30 capsules — AB FDA listed —
Pregabalin 100 mg 72205-0014-06 Novadoz 1000 capsules — AB FDA listed —
Pregabalin 100 mg 72658-0811-01 Eskayef 60 capsules — AB FDA listed —
Pregabalin 100 mg 73190-0056-50 AvKARE 500 capsules — AB Discontinued —
Pregabalin 100 mg 76282-0571-05 Exelan 500 capsules — AB FDA listed —
Pregabalin 100 mg 76420-0098-30 Asclemed 30 capsules — AB FDA listed —
Pregabalin 100 mg 76420-0120-30 Asclemed 30 capsules — AB FDA listed —
Pregabalin 100 mg 80425-0123-03 Advanced 90 capsules — AB FDA listed —
Pregabalin 100 mg 80425-0170-03 Advanced 90 capsules — AB FDA listed —
Pregabalin 100 mg 80425-0277-01 Advanced 30 capsules — AB FDA listed —
Pregabalin 100 mg 82619-0125-01 Creekwood 90 capsules — AB FDA listed —
Pregabalin 100 mg 82804-0247-90 Proficient 90 capsules — AB FDA listed —
Pregabalin 100 mg 82804-0274-60 Proficient 60 capsules — AB FDA listed —
Pregabalin 100 mg 82804-0946-00 Proficient 100 capsules — AB FDA listed —
Pregabalin 100 mg 82968-0009-02 FOURRTS 90 capsules — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
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 Pregabalin — the program that covers self-administered drugs. 20 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 Pregabalin. 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
$62.72M
Claims incl. refills
2.1M
Beneficiaries
1.1M
Spend / beneficiary
$56.99
Spend / claim
$30.01
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 Pregabalin — the ingredient across all brands.

Top reported reactions

Pain26,330
Fatigue15,629
Dizziness14,844
Nausea14,507
Headache13,067
Malaise12,884
Somnolence11,821

Reporter sex

270,557 reports
Male · 34%
Female · 65%
Unknown · 1%

Serious outcomes

Life-threatening12,531
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 22,946 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
00228-2859-09 You're viewing this 90 CAPSULE in 1 BOTTLE (0228-2859-09) 2020-09-10 Discontinued by firm

🧭 About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
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) — Not published for this NDC No structured label is linked to this listing in DailyMed/openFDA.
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) ✓ Available
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

Why is there no full label on this page?
No structured FDA label (SPL) is currently linked to this NDC in DailyMed/openFDA. That can happen with older listings, certain OTC and repackaged products, and recently updated listings whose label has not yet propagated. The listing itself is still valid — this page shows everything the public feeds provide for this package.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 0228-2859-09, 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: 00228-2859-09, written without dashes as 00228285909. 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 00228-2859-09, the first segment (00228) is the labeler code FDA assigned to Actavis Pharma, Inc.; the middle segment (2859) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (09) identifies this exact package size and type. Together they name one specific package of one specific product.
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.
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.
📄 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.
← 00228-2855-11 · Actavis 00228-2890-06 · 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.