Home NDC 50228-442-10 PIRFENIDONE
Product NDC 50228-442
Requested package NDC 50228-442-10
11-digit product format 502280442
Labeler code 50228
Product ID 50228-442_09af4fec-e2cf-2c8d-e063-6294a90af999
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PIRFENIDONE
Dosage form TABLET
Route ORAL
Labeler ScieGen Pharmaceuticals, Inc.
Application ANDA212078
Marketing category ANDA
Marketing start 2022-08-01
Substance PIRFENIDONE
Active strength 267 mg/1
Pharmacologic classes Pyridone [EPC], Pyridones [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A212078-001 PIRFENIDONE PIRFENIDONE 267MG TABLET / ORAL AB 2022-08-01 A212078-002 PIRFENIDONE PIRFENIDONE 801MG TABLET / ORAL AB 2022-08-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A212078-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-08-01 a50c72e98297…2026-08-01 22:54:32 2026-06 A212078-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-08-01 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A212078-001 AB 1 a50c72e98297…2026-08-01 22:54:32 2026-06 A212078-002 AB 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base PIRFENIDONE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PIRFENIDONE 267 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination D7NLD2JX7U Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1868014 Internal RxNorm lookup 1868018 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50228-442-10 PIRFENIDONE 1000 in 1 BOTTLE TABLET 1000 2 50228-442-30 PIRFENIDONE 30 in 1 BOTTLE TABLET 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50228-442 PIRFENIDONE TABLET [SCIEGEN PHARMACEUTICALS, INC.] 2 Current NDC, Legacy NDC, 2 package rows 20231109_155b948e-47f5-4741-8e82-2ed65ccfab7d.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50228-442-10 50228044210 1000 TABLET in 1 BOTTLE (50228-442-10) 1000 tablet 2022-08-01 0000-00-00 No No Current