Home NDC 64380-786 roflumilast
Product NDC 64380-786
11-digit product format 643800786
Labeler code 64380
Product ID 64380-786_9c3f4a61-0aed-418d-b77f-a1864bedee71
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ROFLUMILAST
Dosage form TABLET
Route ORAL
Labeler Strides Pharma Science Limited
Application ANDA208247
Marketing category ANDA
Marketing start 2022-10-13
Substance ROFLUMILAST
Active strength 500 ug/1
Pharmacologic classes Phosphodiesterase 4 Inhibitor [EPC], Phosphodiesterase 4 Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
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 A208247-001 ROFLUMILAST ROFLUMILAST 500MCG TABLET / ORAL AB 2020-03-30 A208247-002 ROFLUMILAST ROFLUMILAST 250MCG TABLET / ORAL AB 2023-06-20
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 A208247-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2020-03-30 a50c72e98297…2026-08-01 22:54:32 2026-06 A208247-002 ROFLUMILAST 250MCG TABLET / ORAL AB 2023-06-20 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 A208247-001 AB 1 a50c72e98297…2026-08-01 22:54:32 2026-06 A208247-002 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 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base roflumilast
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ROFLUMILAST 500 ug/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 64380-786-01 roflumilast 30 in 1 BOTTLE TABLET 30 8 64380-786-05 roflumilast 90 in 1 BOTTLE TABLET 90 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64380-786 ROFLUMILAST TABLET [STRIDES PHARMA SCIENCE LIMITED] 6 Current NDC, Legacy NDC, 2 package rows 20230322_78d2644d-b62c-48f5-8407-2adf09bcb144.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 64380-786-01 64380078601 30 TABLET in 1 BOTTLE (64380-786-01) 30 tablet 2022-10-13 0000-00-00 No No Current 64380-786-05 64380078605 90 TABLET in 1 BOTTLE (64380-786-05) 90 tablet 2022-10-13 0000-00-00 No No Current