Home NDC 0480-3610 Pirfenidone
Product NDC 0480-3610
11-digit product format 004803610
Labeler code 0480
Product ID 0480-3610_eb41bb72-1c2a-4c39-80a6-c09f3bf897fb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pirfenidone
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Teva Pharmaceuticals, Inc.
Application ANDA212759
Marketing category ANDA
Marketing start 2022-05-11
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 NDC auxiliary status# These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
Current NDC status page 1 of 1 · 2 matching rows.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date unfinished product product 0480-3610 UNFINISHED Active or certified unfinished drug listing 2026-08-03 unfinished package package 0480-3610 0480-3610-00 UNFINISHED Active or certified unfinished drug listing 2026-08-03
Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 28 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 21:27 UTC · source 2025-12-05 unfinished product product a6255e0c9aa5…a0211a219f2e…2025-12-14 21:27 UTC · source 2025-12-05 unfinished package package 0480-3610-00 a6255e0c9aa5…a0211a219f2e…2025-08-26 23:59 UTC · source 2025-08-26 unfinished product product 1d862106b807…00c93037cd84…2025-08-26 23:59 UTC · source 2025-08-26 unfinished package package 0480-3610-00 1d862106b807…00c93037cd84…2025-05-15 14:59 UTC · source 2025-05-14 unfinished product product 390b4c401c3f…2c692c2daee3…2025-05-15 14:59 UTC · source 2025-05-14 unfinished package package 0480-3610-00 390b4c401c3f…2c692c2daee3…2025-04-01 07:37 UTC · source 2025-03-31 unfinished product product e30019b0c005…a3f0b14938b7…2025-04-01 07:37 UTC · source 2025-03-31 unfinished package package 0480-3610-00 e30019b0c005…a3f0b14938b7…2025-03-01 13:19 UTC · source 2025-02-28 unfinished product product bbbc9f937eca…946b9c97cf81…2025-03-01 13:19 UTC · source 2025-02-28 unfinished package package 0480-3610-00 bbbc9f937eca…946b9c97cf81…2025-02-27 05:24 UTC · source 2025-02-26 unfinished product product f268b84574a6…26285f5ac5df…2025-02-27 05:24 UTC · source 2025-02-26 unfinished package package 0480-3610-00 f268b84574a6…26285f5ac5df…2025-02-01 13:13 UTC · source 2025-01-31 unfinished product product f764e8902f78…92046438deef…2025-02-01 13:13 UTC · source 2025-01-31 unfinished package package 0480-3610-00 f764e8902f78…92046438deef…2025-01-20 13:05 UTC · source 2025-01-17 unfinished product product 68b1e3bced9e…98a755eb8bc6…2025-01-20 13:05 UTC · source 2025-01-17 unfinished package package 0480-3610-00 68b1e3bced9e…98a755eb8bc6…2024-11-29 20:42 UTC · source 2024-11-29 unfinished product product 05c55d027831…ca05dca9dc4c…2024-11-29 20:42 UTC · source 2024-11-29 unfinished package package 0480-3610-00 05c55d027831…ca05dca9dc4c…2024-11-09 02:36 UTC · source 2024-11-08 unfinished product product 48b4f40e6753…c7c7a00d2afa…2024-11-09 02:36 UTC · source 2024-11-08 unfinished package package 0480-3610-00 48b4f40e6753…c7c7a00d2afa…2024-10-09 02:27 UTC · source 2024-10-08 unfinished product product 27f29a85d7e4…1372111e901f…2024-10-09 02:27 UTC · source 2024-10-08 unfinished package package 0480-3610-00 27f29a85d7e4…1372111e901f…2024-07-10 04:00 UTC · source 2024-07-09 unfinished product product 8d62ce987f31…9fe9ef23e30d…2024-07-10 04:00 UTC · source 2024-07-09 unfinished package package 0480-3610-00 8d62ce987f31…9fe9ef23e30d…2024-05-28 21:11 UTC · source 2024-05-28 unfinished product product d1e113ab4d42…063ee3eb0a1d…2024-05-28 21:11 UTC · source 2024-05-28 unfinished package package 0480-3610-00 d1e113ab4d42…063ee3eb0a1d…2024-05-15 03:51 UTC · source 2024-05-14 unfinished product product 50b4072663b7…eae3003ed65e…2024-05-15 03:51 UTC · source 2024-05-14 unfinished package package 0480-3610-00 50b4072663b7…eae3003ed65e…
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 A212759-001 PIRFENIDONE PIRFENIDONE 267MG TABLET / ORAL AB 2022-01-25 A212759-002 PIRFENIDONE PIRFENIDONE 801MG TABLET / ORAL AB 2022-01-25
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.
Product history page 1 of 2 · 64 observed 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 2026-02-19 14:30 UTC 2026-02 A212759-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-01-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212759-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-01-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212759-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-01-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212759-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-01-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212759-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-01-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212759-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-01-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212759-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-01-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212759-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-01-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212759-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-01-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212759-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-01-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212759-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-01-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212759-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-01-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212759-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-01-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212759-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-01-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212759-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-01-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212759-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-01-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212759-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-01-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212759-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-01-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212759-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-01-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212759-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-01-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212759-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-01-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212759-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-01-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212759-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-01-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212759-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-01-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212759-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-01-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212759-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-01-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212759-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-01-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A212759-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-01-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212759-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-01-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212759-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-01-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212759-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-01-25 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A212759-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-01-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212759-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-01-25 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A212759-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-01-25 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A212759-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-01-25 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A212759-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-01-25 bb7c543d1eb4…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212759-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-01-25 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212759-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-01-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212759-001 PIRFENIDONE 267MG TABLET / ORAL AB 2022-01-25 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A212759-002 PIRFENIDONE 801MG TABLET / ORAL AB 2022-01-25 1c564ffb4f44…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 64 observed states.
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 0480-3610-87 Pirfenidone 270 in 1 BOTTLE TABLET, FILM COATED 270 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0480-3610 PIRFENIDONE TABLET, FILM COATED [TEVA PHARMACEUTICALS, INC.] 5 Current NDC, Legacy NDC, 1 package rows 20250321_cbbd14a4-b7e6-4147-9314-bb715dfb1a51.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0480-3610-00 00480361000 29850 TABLET, FILM COATED in 1 BOX (0480-3610-00) 11-MAY-22 Current 0480-3610-87 00480361087 270 TABLET, FILM COATED in 1 BOTTLE (0480-3610-87) 2022-05-11 0000-00-00 No No Current