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Gabapentin 100 mg Capsule, 30-count — NDC 80425-0595-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Gabapentin 100 mg Capsule, 30-count — NDC 80425-0595-1 (Billing 80425-0595-01)

by Advanced Rx of Tennessee, LLC · 30 CAPSULE in 1 BOTTLE

This is a package of 30 capsules of Gabapentin 100 mg Capsule from Advanced Rx of Tennessee, LLC, marketed since Sep 2026 and currently FDA-listed. It is the main listing for this product, which comes in 4 package sizes.

NDC 80425-0595-01
🏷️ FDA NDC (as labeled) 80425-0595-1 billing pads the package segment with a zero
This package
Contains30-count Pack sizes4 compare ↓
Main listing for product 80425-0595 · Also comes in: 60 capsules 80425-0595-2 90 capsules 80425-0595-3 120 capsules 80425-0595-4
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 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

NDC database record

One package, one record: these facts belong to NDC 80425-0595-1 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
80425 labeler · 0595 product · 1 package
Package marketed since
Sep 11, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 8042505951 8
FDA record last changed
Oct 1, 2026
⚠️
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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 80425-0595-1
Product NDC 80425-0595
11-digit billing NDC 80425059501
Application # ANDA214956
SPL Set ID 5b3ba5e9-6e96-dea6-e063-6394a90aa2bb
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 2026-09-11
Route ORAL
Dosage form CAPSULE
Substance GABAPENTIN
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 80425-0595-1 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 80425-0595-01. 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.

Clinical

📗 Our plain-language guide HelloPharmacist
  • It's used for nerve pain after shingles (postherpetic neuralgia). Many gabapentin products are also used as add-on treatment for partial seizures in epilepsy. Horizant is also used...
  • Dizziness and sleepiness are the most common side effects. Don't drive or use heavy machinery until you know how it affects you, because you may not judge your own impairment well.
  • Talk to your prescriber first. Stopping seizure medicines suddenly can increase seizures. Gralise should be changed or stopped gradually over at least a week.
  • Tell me about any opioid or sedating medicine, because together they can slow breathing dangerously. If you use an antacid like Maalox, take gabapentin at least 2 hours after it.
📖 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.

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: 60 capsules 90 capsules 120 capsules
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
80425-0595-01 You're viewing this Main listing 30 CAPSULE in 1 BOTTLE 2026-09-11 — Active
80425-0595-02 80425-0595-2 60 CAPSULE in 1 BOTTLE 2026-09-11 — Active
80425-0595-03 80425-0595-3 90 CAPSULE in 1 BOTTLE 2026-09-11 — Active
80425-0595-04 80425-0595-4 120 CAPSULE in 1 BOTTLE 2026-09-11 — Active

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

Pack size FAQ

What quantity is in this package?
This is a 30-count package — 30 capsule in 1 bottle.
How does this package differ from NDC 80425-0595-02?
Both are Gabapentin 100 mg Capsule — the drug itself is identical. This page's package is the 30-count one, while NDC 80425-0595-02 is the 60 capsules package.
What NDC number is used to bill for this package of Gabapentin 100 mg Capsule?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Gabapentin 100 mg 70010-0108-01 Granules 100 capsules $0.021 AB Discontinued —
Gabapentin 100 mg 71093-0120-04 ACI 100 capsules $0.022 AB Discontinued —
Gabapentin 100 mg 42385-0972-01 Laurus 100 capsules $0.022 AB Availability likely —
Gabapentin 100 mg 69367-0343-05 Westminster 500 capsules $0.022 AB Availability likely —
Gabapentin 100 mg 45963-0555-11 Actavis 100 capsules $0.022 AB Availability likely —
Gabapentin 100 mg 83301-0003-01 Mullan 100 capsules $0.022 AB Availability likely —
Gabapentin 100 mg 65862-0198-01 Aurobindo 100 capsules $0.022 AB Availability likely —
gabapentin 100 mg 16571-0867-01 Rising 100 capsules $0.022 AB Availability likely —
Gabapentin 100 mg 49483-0605-01 TIME 100 capsules $0.022 AB Availability likely —
Gabapentin 100 mg 64380-0753-01 Strides 100 capsules $0.022 AB Availability likely —
Gabapentin 100 mg 23155-0866-01 Heritage 100 capsules $0.022 AB Availability likely —
Gabapentin 100 mg 60687-0580-01 American 100 capsules $0.022 AB Availability likely —
Gabapentin 100 mg 69367-0131-06 Westminster 500 capsules $0.022 AB Availability likely —
Gabapentin 100 mg 70010-0926-01 Granules 100 capsules $0.022 AB Availability likely —
Gabapentin 100 mg 31722-0148-01 Camber 100 capsules $0.022 AB Availability likely —
Gabapentin 100 mg 69292-0640-01 Amici 100 capsules $0.022 AB Availability likely —
Gabapentin 100 mg 16714-0661-01 NorthStar 100 capsules $0.022 AB Availability likely —
Gabapentin 100 mg 00904-6665-61 Major 100 capsules $0.022 AB Availability likely —
Gabapentin 100 mg 50228-0179-01 ScieGen 100 capsules $0.022 AB Availability likely —
Gabapentin 100 mg 67877-0222-01 Ascend 100 capsules $0.022 AB Availability likely —
Gabapentin 100 mg 69097-0813-07 Cipla 100 capsules $0.022 AB Availability likely —
Gabapentin 100 mg 64380-0867-06 Strides 100 capsules $0.025 AB FDA listed —
Gabapentin 100 mg 63739-0902-10 McKesson 100 capsules $0.025 AB FDA listed —
Neurontin 100 mg 00071-0803-24 Parke-Davis 100 capsules $2.958 AB Discontinued —
Neurontin 100 mg 58151-0281-01 Viatris 100 capsules $2.958 AB Availability likely —
Gabapentin 100 mg 42582-0114-10 Bi-Coastal 100 capsules — AB FDA listed —
Gabapentin 100 mg 42806-0509-01 Epic 100 capsules — AB FDA listed —
Gabapentin 100 mg 63187-0392-00 Proficient 100 capsules — AB FDA listed —
Gabapentin 100 mg 71205-0317-30 Proficient 30 capsules — AB FDA listed —
Gabapentin 100 mg 71205-0373-15 Proficient 15 capsules — AB FDA listed —
Gabapentin 100 mg 71205-0638-30 Proficient 30 capsules — AB FDA listed —
Gabapentin 100 mg 71205-0661-15 Proficient 15 capsules — AB FDA listed —
Gabapentin 100 mg 71205-0928-00 Proficient 100 capsules — AB FDA listed —
Gabapentin 100 mg 71610-0072-60 Aphena 90 capsules — AB FDA listed —
Gabapentin 100 mg 71610-0126-60 Aphena 90 capsules — AB FDA listed —
Gabapentin 100 mg 71610-0667-30 Aphena 30 capsules — AB FDA listed —
Gabapentin 100 mg 76420-0014-30 Asclemed 30 capsules — AB FDA listed —
Gabapentin 100 mg 50090-0949-00 A-S 30 capsules — AB FDA listed —
Gabapentin 100 mg 53746-0101-01 Amneal 100 capsules — AB FDA listed —
Gabapentin 100 mg 60760-0818-60 St. 60 capsules — AB FDA listed —
Gabapentin 100 mg 71610-0421-30 Aphena 30 capsules — AB FDA listed —
Gabapentin 100 mg 71610-0756-30 Aphena 30 capsules — AB FDA listed —
Gabapentin 100 mg 82868-0074-30 Northwind 30 capsules — AB FDA listed —
Gabapentin 100 mg 50090-3200-00 A-S 30 capsules — AB FDA listed —
Gabapentin 100 mg 50090-7673-00 A-S 90 capsules — AB FDA listed —
Gabapentin 100 mg 71335-0073-00 Bryant 65 capsules — AB FDA listed —
Gabapentin 100 mg 71335-1198-00 Bryant 65 capsules — AB Discontinued —
Gabapentin 100 mg 76282-0321-01 Exelan 100 capsules — AB FDA listed —
Gabapentin 100 mg 76420-0259-01 Asclemed 100 capsules — AB FDA listed —
Gabapentin 100 mg 45865-0216-30 Medsource 30 capsules — AB FDA listed —
Gabapentin 100 mg 55154-3363-00 Cardinal 10 capsules — AB FDA listed —
Gabapentin 100 mg 55700-0950-01 Quality 120 capsules — AB Discontinued —
Gabapentin 100 mg 60760-0669-30 St. 30 capsules — AB FDA listed —
Gabapentin 100 mg 60760-0740-60 St. 60 capsules — AB Discontinued —
Gabapentin 100 mg 67046-1257-03 Coupler 30 capsules — AB FDA listed —
Gabapentin 100 mg 68788-4107-01 Preferred 100 capsules — AB FDA listed —
Gabapentin 100 mg 68788-8194-01 Preferred 100 capsules — AB FDA listed —
Gabapentin 100 mg 72865-0252-05 XLCare 500 capsules — AB FDA listed —
Gabapentin 100 mg 60760-0926-30 ST. 30 capsules — AB FDA listed —
Gabapentin 100 mg 63629-8485-01 Bryant 100 capsules — AB FDA listed —
Gabapentin 100 mg 68071-3664-03 NuCare 30 capsules — AB FDA listed —
Gabapentin 100 mg 68788-8563-01 Preferred 100 capsules — AB FDA listed —
Gabapentin 100 mg 71335-2005-01 Bryant 90 capsules — AB FDA listed —
Gabapentin 100 mg 72162-2138-01 Bryant 100 capsules — AB FDA listed —
Gabapentin 100 mg 72189-0419-30 Direct_Rx 30 capsules — AB FDA listed —
Gabapentin 100 mg 72789-0289-30 PD-Rx 30 capsules — AB FDA listed —
Gabapentin 100 mg 82804-0226-30 Proficient 30 capsules — AB FDA listed —
gabapentin 100 mg 62756-0137-01 Sun 50 capsules — — FDA listed —
Gabapentin 100 mg 68071-2600-06 NuCare 60 capsules — AB FDA listed —
Gabapentin 100 mg 68071-3759-01 NuCare 100 capsules — AB FDA listed —
Gabapentin 100 mg 70518-2614-00 REMEDYREPACK 90 capsules — AB FDA listed —
Gabapentin 100 mg 70518-4261-00 REMEDYREPACK 30 capsules — AB FDA listed —
Gabapentin 100 mg 71335-1991-00 Bryant 65 capsules — AB FDA listed —
Gabapentin 100 mg 71335-2053-01 Bryant 90 capsules — AB FDA listed —
Gabapentin 100 mg 71335-2279-01 Bryant 1000 capsules — AB FDA listed —
Gabapentin 100 mg 72162-1532-01 Bryant 100 capsules — AB FDA listed —
Gabapentin 100 mg 72737-0005-01 STALLION 30 capsules — AB FDA listed —
Gabapentin 100 mg 76420-0868-00 Asclemed 1000 capsules — AB FDA listed —
Gabapentin 100 mg 00904-7613-61 Major 100 capsules — AB FDA listed —
Gabapentin 100 mg 25000-0103-01 MARKSANS 4000 capsules — AB FDA listed —
Gabapentin 100 mg 50090-7169-00 A-S 90 capsules — AB FDA listed —
Gabapentin 100 mg 50090-7389-00 A-S 90 capsules — AB FDA listed —
Gabapentin 100 mg 68071-4978-09 NuCare 90 capsules — AB FDA listed —
Gabapentin 100 mg 71335-1484-01 Bryant 90 capsules — AB FDA listed —
Gabapentin 100 mg 71335-1655-00 Bryant 65 capsules — AB FDA listed —
Gabapentin 100 mg 43547-0479-10 Solco 100 capsules — AB FDA listed —
Gabapentin 100 mg 67296-2192-03 Redpharm 30 capsules — AB FDA listed —
Gabapentin 100 mg 68788-8199-01 Preferred 100 capsules — AB FDA listed —
Gabapentin 100 mg 70518-1834-00 REMEDYREPACK 30 capsules — AB FDA listed —
Gabapentin 100 mg 71335-3140-01 Bryant 90 capsules — AB FDA listed —
Gabapentin 100 mg 80425-0150-02 Advanced 60 capsules — AB FDA listed —
Gabapentin 100 mg 50090-7388-00 A-S 30 capsules — AB FDA listed —
Gabapentin 100 mg 50090-7672-00 A-S 30 capsules — AB FDA listed —
Gabapentin 100 mg 51407-0047-10 Golden 1000 capsules — AB Discontinued —
Gabapentin 100 mg 58118-2101-08 Clinical 30 capsules — AB FDA listed —
Gabapentin 100 mg 60760-0939-60 St. 60 capsules — AB FDA listed —
Gabapentin 100 mg 69434-0042-03 Zhejiang 500 capsules — AB FDA listed —
Gabapentin 100 mg 70518-4493-00 REMEDYREPACK 100 capsules — AB FDA listed —
Gabapentin 100 mg 71335-1169-00 Bryant 65 capsules — AB Discontinued —
Gabapentin 100 mg 71335-1375-01 Bryant 90 capsules — AB Discontinued —
Gabapentin 100 mg 72189-0460-60 Direct_Rx 60 capsules — AB FDA listed —
Gabapentin 100 mg 80425-0199-01 Advanced 30 capsules — AB FDA listed —
Gabapentin 100 mg 50090-6875-00 A-S 90 capsules — AB FDA listed —
Gabapentin 100 mg 63629-8484-01 Bryant 500 capsules — AB FDA listed —
Gabapentin 100 mg 65162-0101-03 Amneal 30 capsules — AB FDA listed —
Gabapentin 100 mg 72189-0384-90 Direct_Rx 90 capsules — AB FDA listed —
Gabapentin 100 mg 72789-0123-30 PD-Rx 30 capsules — AB FDA listed —
Gabapentin 100 mg 80425-0128-02 Advanced 60 capsules — AB FDA listed —
Gabapentin 100 mg 55154-8194-00 Cardinal 10 capsules — AB FDA listed —
Gabapentin 100 mg 68788-8489-01 Preferred 100 capsules — AB FDA listed —
Gabapentin 100 mg 72189-0109-30 DIRECT 30 capsules — AB FDA listed —
Gabapentin 100 mg 00480-3494-77 Teva 38668 capsules — AB FDA listed —
Gabapentin 100 mg 82619-0142-01 Creekwood 100 capsules — AB FDA listed —
Gabapentin 100 mg 82804-0178-90 Proficient 90 capsules — AB FDA listed —
Gabapentin 100 mg 68071-5017-01 NuCare 100 capsules — AB FDA listed —
Gabapentin 100 mg 70518-3330-00 REMEDYREPACK 100 capsules — AB Discontinued —
Gabapentin 100 mg 71335-2741-01 Bryant 90 capsules — AB FDA listed —
Gabapentin 100 mg 87441-0034-01 Unit 30 capsules — AB FDA listed —
Gabapentin 100 mg 85534-0055-00 HAWAII 30 capsules — AB FDA listed —
Gabapentin 100 mg 87063-0687-12 ASCLEMED 120 capsules — AB FDA listed —
Gabapentin 100 mg 85534-0003-00 HAWAII 30 capsules — AB FDA listed —
gabapentin 100 mg 70518-4706-00 REMEDYREPACK 30 capsules — AB FDA listed —
Gabapentin 100 mg 82868-0108-30 Northwind 30 capsules — AB FDA listed —
Gabapentin 100 mg 70518-4742-00 REMEDYREPACK 100 capsules — AB FDA listed —
Gabapentin 100 mgthis 80425-0595-01 Advanced 30 capsules — AB FDA listed —
Gabapentin 100 mg 55154-0581-00 Cardinal 10 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.

What it looks like

Color white
ShapeCapsule
ImprintA;469
Size16 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.

🧪 Avoiding an ingredient? See Gabapentin inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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

  • 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 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 46N107B71O
    Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
  • 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.

13 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.

Manufacturer & labeler

LabelerAdvanced Rx of Tennessee, LLC
Application holderASCENT PHARMACEUTICALS INC
FDA applicationANDA214956 (ANDA)
Labeler code80425
First marketedSep 2026
Product typeHuman Prescription Drug
Portfolio280 products on file

More NDCs from Advanced Rx of Tennessee, LLC labeler code 80425

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.

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 ↗

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.

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Advanced Rx of Tennessee, LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 60 capsules (80425-0595-02), 90 capsules (80425-0595-03), 120 capsules (80425-0595-04). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Advanced Rx of Tennessee, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
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For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.