Home NDC 0904-7399 Roflumilast
Product NDC 0904-7399
11-digit product format 009047399
Labeler code 0904
Product ID 0904-7399_44dcecac-a91b-4149-b030-d44e925bee4b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Roflumilast
Dosage form TABLET
Route ORAL
Labeler MAJOR PHARMACEUTICALS
Application ANDA208256
Marketing category ANDA
Marketing start 2023-12-26
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 A208256-001 ROFLUMILAST ROFLUMILAST 250MCG TABLET / ORAL AB 2022-09-07 A208256-002 ROFLUMILAST ROFLUMILAST 500MCG TABLET / ORAL AB 2022-09-07
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 A208256-001 ROFLUMILAST 250MCG TABLET / ORAL AB 2022-09-07 a50c72e98297…2026-08-01 22:54:32 2026-06 A208256-002 ROFLUMILAST 500MCG TABLET / ORAL AB 2022-09-07 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 A208256-001 AB 1 a50c72e98297…2026-08-01 22:54:32 2026-06 A208256-002 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 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 0904-7399-46 Roflumilast 30 in 1 BOTTLE TABLET 30 4 0904-7399-89 Roflumilast 90 in 1 BOTTLE TABLET 90 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0904-7399 ROFLUMILAST TABLET [MAJOR PHARMACEUTICALS] 2 Current NDC, 2 package rows 20240612_c51b80f3-a591-4db9-81b4-b91603e35d7c.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 0904-7399-46 00904739946 30 TABLET in 1 BOTTLE (0904-7399-46) 30 tablet 2023-12-26 No No Current 0904-7399-89 00904739989 90 TABLET in 1 BOTTLE (0904-7399-89) 90 tablet 2023-12-26 No No Current