Home NDC 72205-201 Roflumilast
Product NDC 72205-201
11-digit product format 722050201
Labeler code 72205
Product ID 72205-201_b56e7d3f-9930-43fa-baf4-63f9cee750f2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Roflumilast
Dosage form TABLET
Route ORAL
Labeler Novadoz Pharmaceuticals LLC
Application ANDA208256
Marketing category ANDA
Marketing start 2022-09-07
Substance ROFLUMILAST
Active strength 250 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 250 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 72205-201-11 Roflumilast 10 in 1 BLISTER PACK TABLET 10 3 72205-201-13 Roflumilast 14 in 1 BLISTER PACK TABLET 14 3 72205-201-24 Roflumilast 2 in 1 CARTON TABLET 2 3 72205-201-30 Roflumilast 30 in 1 BOTTLE TABLET 30 3 72205-201-32 Roflumilast 2 in 1 CARTON TABLET 2 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72205-201 ROFLUMILAST TABLET [NOVADOZ PHARMACEUTICALS LLC] 3 Current NDC, Legacy NDC, 5 package rows 20240829_4d25f69c-58b7-4e2a-b835-4d0c76a83c7c.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 72205-201-11 72205020111 10 in 1 BLISTER PACK Historical 72205-201-13 72205020113 14 in 1 BLISTER PACK Historical 72205-201-24 72205020124 2 BLISTER PACK in 1 CARTON (72205-201-24) / 10 TABLET in 1 BLISTER PACK (72205-201-11) 2 blister pack 2022-09-24 0000-00-00 No No Current 72205-201-30 72205020130 30 TABLET in 1 BOTTLE (72205-201-30) 30 tablet 2022-12-21 No No Current 72205-201-32 72205020132 2 BLISTER PACK in 1 CARTON (72205-201-32) / 14 TABLET in 1 BLISTER PACK (72205-201-13) 2 blister pack 2022-09-24 0000-00-00 No No Current