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Pirfenidone 267 mg Tablet, Film Coated — NDC 0904-7397-53 (Billing 00904-7397-53)

by MAJOR PHARMACEUTICALS · 3 BOTTLE in 1 CARTON / 90 TABLET, FILM COATED in 1 BOTTLE

This is a package of Pirfenidone 267 mg Tablet, Film Coated from MAJOR PHARMACEUTICALS, marketed since May 2022 and currently FDA-listed; retail pharmacies pay about $0.6855 per unit (NADAC). It is this product's only package size.

NDC 00904-7397-53
🏷️ FDA NDC (as labeled) 0904-7397-53 billing pads the labeler segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Oct 8, 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 0904-7397-53 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0904 labeler · 7397 product · 53 package
Package marketed since
Mar 2, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 0904739753 2
FDA record last changed
Oct 8, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0904-7397-53
Product NDC 0904-7397
11-digit billing NDC 00904739753
NCPDP billing unit EA — each (per item)
Application # ANDA212772
SPL Set ID 24b60d05-c1f7-4fba-ba4f-009eceb0c409
Established class (EPC) Pyridone
Chemical class Pyridones
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-05-24
Route ORAL
Dosage form TABLET, FILM COATED
Substance PIRFENIDONE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 077032
GCN 42903
HICL code 040237
Ingredient (HICL) Pirfenidone
HIC1 code Z
Therapeutic class — broad (HIC1) Body As A Whole
HIC2 code Z1
Therapeutic class — intermediate (HIC2) Positive Effects On Wide-Spread Tissue
HIC3 code Z1M
Therapeutic class — specific (HIC3) Antifibrotic Therapy - Pyridone Analogs
AHFS code 48:02.00.00
AHFS class Antifibrotic Agents
FDB label name PIRFENIDONE 267 MG TABLET
FDB brand name Pirfenidone
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 077032
  • GCN: 42903
  • HICL (First Databank): 040237
  • AHFS class code: 48:02.00.00
Why two NDCs? The FDA registers this code as 0904-7397-53 — 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 → 00904-7397-53. 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

Label name PIRFENIDONE 267 MG TABLET Ingredient Pirfenidone
📖 What it is MedlinePlus · NLM

Pirfenidone is used for the treatment of idiopathic pulmonary fibrosis (scarring of the lungs with an unknown cause). Pirfenidone is in a class of medications called pyridones. It works by blocking the action of a certain natural substance in the body that is involved in causing fibrosis.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It treats idiopathic pulmonary fibrosis, or IPF, a lung disease where scarring builds up for no known reason. Esbriet and generic pirfenidone capsules and tablets are all labeled f...
  • Take it by mouth three times a day with food, at about the same times each day. You’ll start low and build up over about 14 days. If you miss a dose, don’t double up, and never tak...
  • Nausea, rash, stomach pain, diarrhea, tiredness and decreased appetite are common. Stomach effects are usually worst in the first few months and often ease. Tell us if they get bot...
  • Yes. Pirfenidone can make your skin sensitive to sunlight. Avoid sun and sunlamps, wear sunscreen and cover up daily. Let your doctor know if you develop a rash.
📖 Read our full Pirfenidone 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.

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 $0.686 $185.09 / 270 tablets
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $24.12 $6,512.40 / 270 tablets
NADAC price history (per ea) — tap or hover for the price & month
Dec 2025 Mar 2026 Jun 2026 Sep 2026 $1.516 $0.686
▼ Down 45% over the last 10 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00904-7397-53 You're viewing this Main listing 3 BOTTLE in 1 CARTON / 90 TABLET, FILM COATED in 1 BOTTLE 2024-03-02 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Pirfenidone 267 mg 00480-3610-87 Teva 270 tablets $0.685 AB Availability likely —
Pirfenidone 267 mg 00781-8085-32 Sandoz 270 tablets $0.685 AB Availability likely —
Pirfenidone 267 mgthis 00904-7397-53 MAJOR 90 tablets $0.685 AB Availability likely —
Pirfenidone 267 mg 31722-0872-27 Camber 90 tablets $0.685 AB Availability likely —
Pirfenidone 267 mg 42385-0924-99 Laurus 90 tablets $0.685 AB Availability likely —
Pirfenidone 267 mg 59651-0238-27 Aurobindo 270 tablets $0.685 AB Availability likely —
Pirfenidone 267 mg 60219-1640-08 Amneal 90 tablets $0.685 AB Availability likely —
Pirfenidone 267 mg 60505-4681-07 Apotex 270 tablets $0.685 AB Availability likely —
Pirfenidone 267 mg 62332-0479-64 Alembic 90 tablets $0.685 AB Availability likely —
Pirfenidone 267 mg 72205-0181-26 Novadoz 90 tablets $0.685 AB Availability likely —
Pirfenidone 267 mg 72603-0258-03 Northstar 90 tablets $0.685 AB Availability likely —
Pirfenidone 267 mg 76282-0717-27 EXELAN 270 tablets $0.685 AB Availability likely —
Pirfenidone 267 mg 16729-0467-85 Accord 90 tablets — AB FDA listed —
Pirfenidone 267 mg 42291-0491-27 AvKARE 90 tablets — AB FDA listed —
Pirfenidone 267 mg 42571-0335-90 Micro 90 tablets — AB FDA listed —
Pirfenidone 267 mg 46708-0479-27 Alembic 270 tablets — AB FDA listed —
Pirfenidone 267 mg 50228-0442-10 ScieGen 1000 tablets — AB FDA listed —
Esbriet 267 mg 50242-0122-06 Genentech, 270 tablets — AB FDA listed —
Pirfenidone 267 mg 51407-0913-27 Golden 270 tablets — AB FDA listed —
Pirfenidone 267 mg 69097-0987-05 Cipla 90 tablets — AB FDA listed —
Pirfenidone 267 mg 69238-1640-08 Amneal 90 tablets — AB FDA listed —
Pirfenidone 267 mg 70954-0869-10 ANI 90 tablets — AB FDA listed —
Pirfenidone 267 mg 71335-2944-01 Bryant 90 tablets — AB FDA listed —
Pirfenidone 267 mg 72162-2465-02 Bryant 90 tablets — AB FDA listed —
Esbriet 267 mg 83107-0028-27 Legacy 270 tablets — 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

🏛️
2022
On the market since
May 2022
📍
2026
Currently FDA-listed
4 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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

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 Pirfenidone 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.

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.

Manufacturer & labeler

LabelerMAJOR PHARMACEUTICALS
Application holderMSN LABORATORIES PRIVATE LTD
FDA applicationANDA212772 (ANDA)
Labeler code00904
First marketedMay 2022
Product typeHuman Prescription Drug
Portfolio630 products on file

More NDCs from MAJOR PHARMACEUTICALS labeler code 00904

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 Pirfenidone — the program that covers self-administered drugs. 10 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 Pirfenidone. 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
$30.43M
Claims incl. refills
18.3K
Beneficiaries
7.6K
Spend / beneficiary
$3,980.59
Spend / claim
$1,662.26
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.
← 00904-7396-46 · MAJOR 00904-7398-89 · MAJOR →
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.