Home NDC 59651-275 ROFLUMILAST
Product NDC 59651-275
11-digit product format 596510275
Labeler code 59651
Product ID 59651-275_586e58c7-172f-4c3f-a91f-045ea4d089fc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ROFLUMILAST
Dosage form TABLET
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA213298
Marketing category ANDA
Marketing start 2023-04-17
Substance ROFLUMILAST
Active strength 500 ug/1
Pharmacologic classes Phosphodiesterase 4 Inhibitor [EPC], Phosphodiesterase 4 Inhibitors [MoA]
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 A213298-001 ROFLUMILAST ROFLUMILAST 500MCG TABLET / ORAL AB 2023-04-17 A213298-002 ROFLUMILAST ROFLUMILAST 250MCG TABLET / ORAL AB 2025-01-31
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 2026-02-19 14:30 UTC 2026-02 A213298-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2023-04-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213298-002 ROFLUMILAST 250MCG TABLET / ORAL AB 2025-01-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213298-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2023-04-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213298-002 ROFLUMILAST 250MCG TABLET / ORAL AB 2025-01-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213298-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2023-04-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213298-002 ROFLUMILAST 250MCG TABLET / ORAL AB 2025-01-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213298-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2023-04-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213298-002 ROFLUMILAST 250MCG TABLET / ORAL AB 2025-01-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213298-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2023-04-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213298-002 ROFLUMILAST 250MCG TABLET / ORAL AB 2025-01-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213298-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2023-04-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213298-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2023-04-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213298-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2023-04-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213298-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2023-04-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213298-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2023-04-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213298-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2023-04-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213298-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2023-04-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213298-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2023-04-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213298-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2023-04-17 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213298-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2023-04-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213298-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2023-04-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213298-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2023-04-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213298-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2023-04-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213298-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2023-04-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213298-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2023-04-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A213298-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2023-04-17 3f0d92c62455…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213298-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2023-04-17 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213298-002 ROFLUMILAST 250MCG TABLET / ORAL AB 2025-01-31 a50c72e98297…
Observed Orange Book normalized TE history# 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 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base ROFLUMILAST
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ROFLUMILAST 500 ug/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0P6C6ZOP5U Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1091839 Internal RxNorm lookup 2001319 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 59651-275-30 ROFLUMILAST 30 in 1 BOTTLE TABLET 30 6 59651-275-90 ROFLUMILAST 90 in 1 BOTTLE TABLET 90 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59651-275 ROFLUMILAST TABLET [AUROBINDO PHARMA LIMITED] 6 Current NDC, 2 package rows 20250529_7cb11d48-6bb9-437b-bc7f-382050a2d3e6.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 59651-275-30 59651027530 30 TABLET in 1 BOTTLE (59651-275-30) 30 tablet 2023-04-17 No No Current 59651-275-90 59651027590 90 TABLET in 1 BOTTLE (59651-275-90) 90 tablet 2023-04-17 No No Current