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Pregabalin 200 mg Capsule, 30-count — NDC 70518-4749-00 package photo

Pregabalin 200 mg Capsule, 30-count

by REMEDYREPACK INC. · 30 CAPSULE in 1 BLISTER PACK (70518-4749-0)
NDC 70518-4749-00
🏷️ FDA NDC (as labeled) 70518-4749-0 billing pads the package segment with a zero
Rx only Generic On market CV
🗂️ Data synced Sep 17, 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 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 ↗

🆔 Identity & classification

FDA NDC (as labeled) 70518-4749-0
Product NDC 70518-4749
11-digit billing NDC 70518474900
Application # ANDA206912
SPL Set ID d8ca08a5-92a1-4efa-9ecd-c228a1fb63a3
DEA schedule CV
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-09-10
Route ORAL
Dosage form CAPSULE
Substance PREGABALIN
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 70518-4749-0 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 70518-4749-00. 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

LabelerREMEDYREPACK INC.
Application holderHETERO LABS LTD UNIT III
FDA applicationANDA206912 (ANDA)
Labeler code70518
First marketedSep 2026
DEA scheduleCV
Product typeHuman Prescription Drug
Portfolio1,511 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

📗 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.

💊 What it looks like

Color orange
ShapeCapsule
Imprint143;J
Size19 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

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

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII 5138Q19F1X
    Ammonia is a colorless gas made from nitrogen and hydrogen. It's used in medicines as a pH buffer to maintain the correct acidity level and help keep the product stable.
  • UNII 8PJ61P6TS3
    Butyl alcohol is a clear liquid organic solvent derived from petroleum or natural sources. In medicines, it helps dissolve active ingredients and serves as a solvent in liquid formulations and some topical products.
  • UNII 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII ND2M416302
    Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
  • UNII 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • UNII WZH3C48M4T
    Potassium hydroxide is a strong alkaline chemical used in medicines to adjust and maintain the pH level of liquid formulations, helping keep the product stable and the active ingredients effective.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII MB5IUD6JUA
    Shellac is a natural resin secreted by lac beetles, purified and processed into a coating material. It seals and protects tablets and capsules, controls how quickly the medicine dissolves, and gives pills their glossy finish.
  • UNII 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • 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.

15 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 · 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.
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 200 mg 50228-0650-05 ScieGen 500 capsules $0.057 AB Availability likely —
Pregabalin 200 mg 31722-0615-05 Camber 500 capsules $0.057 AB Availability likely —
Pregabalin 200 mg 69238-1315-09 Amneal 90 capsules $0.057 AB Availability likely —
Pregabalin 200 mg 69367-0429-05 Westminster 500 capsules $0.057 AB Availability likely —
Pregabalin 200 mg 00904-7003-04 Major 30 capsules $0.057 AB Availability likely —
Pregabalin 200 mg 72603-0357-01 NorthStar 90 capsules $0.057 AB Availability likely —
Pregabalin 200 mg 43547-0511-09 Solco 90 capsules $0.057 AB Availability likely —
Pregabalin 200 mg 69367-0329-09 Westminster 90 capsules $0.057 AB Availability likely —
Pregabalin 200 mg 67877-0467-05 Ascend 500 capsules $0.057 AB Availability likely —
Pregabalin 200 mg 69097-0959-05 Cipla 90 capsules $0.074 AB FDA listed —
Pregabalin 200 mg 27808-0239-01 Tris 90 capsules $0.074 AB FDA listed —
Lyrica 200 mg 58151-0241-77 Viatris 90 capsules $9.690 AB Availability likely —
Lyrica 200 mg 00071-1017-68 Parke-Davis 90 capsules $9.693 AB Discontinued —
Pregabalin 200 mg 71205-0874-00 Proficient 100 capsules — AB FDA listed —
Pregabalin 200 mg 76420-0100-30 Asclemed 30 capsules — AB FDA listed —
Pregabalin 200 mg 76420-0122-30 Asclemed 30 capsules — AB FDA listed —
Pregabalin 200 mg 46708-0124-10 Alembic 100 capsules — AB FDA listed —
Pregabalin 200 mg 71610-0754-30 Aphena 30 capsules — AB FDA listed —
Pregabalin 200 mg 71610-0759-30 Aphena 30 capsules — AB FDA listed —
Pregabalin 200 mg 50090-7983-00 A-S 60 capsules — AB FDA listed —
Pregabalin 200 mg 71335-1555-01 Bryant 30 capsules — AB Discontinued —
Pregabalin 200 mg 71610-0948-30 Aphena 30 capsules — AB FDA listed —
Pregabalin 200 mg 50228-0355-05 ScieGen 500 capsules — AB FDA listed —
Pregabalin 200 mg 55700-0964-60 Quality 60 capsules — AB FDA listed —
Pregabalin 200 mg 60219-1315-09 Amneal 90 capsules — AB FDA listed —
Pregabalin 200 mg 72162-1546-09 Bryant 90 capsules — AB FDA listed —
Pregabalin 200 mg 82968-0011-01 FOURRTS 90 capsules — AB FDA listed —
Pregabalin 200 mg 64980-0415-01 Rising 100 capsules — AB FDA listed —
Pregabalin 200 mg 71610-0318-53 Aphena 60 capsules — AB FDA listed —
Pregabalin 200 mg 73190-0058-50 AvKARE 500 capsules — AB Discontinued —
Pregabalin 200 mg 82619-0127-01 Creekwood 90 capsules — AB FDA listed —
Pregabalin 200 mg 13668-0363-01 Torrent 100 capsules — AB FDA listed —
Pregabalin 200 mg 60760-0729-30 ST. 30 capsules — AB FDA listed —
pregabalin 200 mg 14445-0126-90 Indoco 90 capsules — AB FDA listed —
Pregabalin 200 mg 47335-0691-08 Sun 100 capsules — — FDA listed —
Pregabalin 200 mg 70518-2763-00 REMEDYREPACK 90 capsules — AB Discontinued —
Pregabalin 200 mg 71610-0997-30 Aphena 30 capsules — AB FDA listed —
Pregabalin 200 mg 76282-0573-05 Exelan 500 capsules — AB FDA listed —
pregabalin 200 mg 43598-0296-05 Dr.Reddys 500 capsules — AB FDA listed —
Pregabalin 200 mg 50090-6504-00 A-S 60 capsules — AB FDA listed —
Pregabalin 200 mg 62332-0124-10 Alembic 100 capsules — AB FDA listed —
Pregabalin 200 mg 65862-0763-05 Aurobindo 500 capsules — AB FDA listed —
Pregabalin 200 mg 72189-0241-60 Direct_Rx 60 capsules — AB FDA listed —
Pregabalin 200 mg 72205-0016-06 Novadoz 1000 capsules — AB FDA listed —
Pregabalin 200 mg 82804-0948-00 Proficient 100 capsules — AB FDA listed —
Pregabalin 200 mg 71610-0926-30 Aphena 30 capsules — AB FDA listed —
Pregabalin 200 mg 25000-0184-07 MARKSANS 90 capsules — AB FDA listed —
Pregabalin 200 mg 51407-0579-90 Golden 90 capsules — AB FDA listed —
Pregabalin 200 mg 71335-9699-01 Bryant 30 capsules — AB FDA listed —
Pregabalin 200 mg 58118-1467-08 Clinical 30 capsules — AB FDA listed —
Pregabalin 200 mg 63629-8208-01 Bryant 30 capsules — AB Discontinued —
Pregabalin 200 mg 71209-0037-04 Cadila 90 capsules — — FDA listed —
Pregabalin 200 mg 71335-1822-01 Bryant 30 capsules — AB FDA listed —
Pregabalin 200 mg 72658-0849-01 Eskayef 60 capsules — AB FDA listed —
Pregabalin 200 mg 80425-0308-01 Advanced 30 capsules — AB FDA listed —
Pregabalin 200 mg 68788-7527-01 Preferred 100 capsules — AB FDA listed —
Pregabalin 200 mg 29300-0444-19 Unichem 90 capsules — AB FDA listed —
Pregabalin 200 mgthis 70518-4749-00 REMEDYREPACK 30 capsules — AB FDA listed —
Pregabalin 200 mg 58118-0763-08 Clinical 30 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
On the market since
Sep 2026
📍
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
70518-4749-00 You're viewing this 30 CAPSULE in 1 BLISTER PACK (70518-4749-0) 2026-09-10 Active

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ 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 70518-4749-0, 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: 70518-4749-00, written without dashes as 70518474900. 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 70518-4749-00, the first segment (70518) is the labeler code FDA assigned to REMEDYREPACK INC.; the middle segment (4749) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (00) 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 REMEDYREPACK INC.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
REMEDYREPACK 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. Prefer the government’s original formatting? View this label on DailyMed ↗
← 70518-4748-00 · REMEDYREPACK 70518-4750-00 · REMEDYREPACK →
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.