Home NDC 68382-969 Roflumilast
Product NDC 68382-969
11-digit product format 683820969
Labeler code 68382
Product ID 68382-969_70642eb6-1ced-4f90-85b2-7d4238c197d0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Roflumilast
Dosage form TABLET
Route ORAL
Labeler Zydus Pharmaceuticals USA Inc.
Application ANDA208303
Marketing category ANDA
Marketing start 2022-10-03
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 A208303-001 ROFLUMILAST ROFLUMILAST 500MCG TABLET / ORAL AB 2022-02-10 A208303-002 ROFLUMILAST ROFLUMILAST 250MCG TABLET / ORAL AB 2023-04-18
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 · 53 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 A208303-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2022-02-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208303-002 ROFLUMILAST 250MCG TABLET / ORAL AB 2023-04-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208303-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2022-02-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208303-002 ROFLUMILAST 250MCG TABLET / ORAL AB 2023-04-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208303-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2022-02-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208303-002 ROFLUMILAST 250MCG TABLET / ORAL AB 2023-04-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208303-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2022-02-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208303-002 ROFLUMILAST 250MCG TABLET / ORAL AB 2023-04-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208303-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2022-02-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208303-002 ROFLUMILAST 250MCG TABLET / ORAL AB 2023-04-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208303-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2022-02-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208303-002 ROFLUMILAST 250MCG TABLET / ORAL AB 2023-04-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208303-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2022-02-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208303-002 ROFLUMILAST 250MCG TABLET / ORAL AB 2023-04-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208303-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2022-02-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208303-002 ROFLUMILAST 250MCG TABLET / ORAL AB 2023-04-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208303-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2022-02-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208303-002 ROFLUMILAST 250MCG TABLET / ORAL AB 2023-04-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208303-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2022-02-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208303-002 ROFLUMILAST 250MCG TABLET / ORAL AB 2023-04-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208303-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2022-02-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208303-002 ROFLUMILAST 250MCG TABLET / ORAL AB 2023-04-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208303-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2022-02-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208303-002 ROFLUMILAST 250MCG TABLET / ORAL AB 2023-04-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208303-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2022-02-10 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208303-002 ROFLUMILAST 250MCG TABLET / ORAL AB 2023-04-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208303-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2022-02-10 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A208303-002 ROFLUMILAST 250MCG TABLET / ORAL AB 2023-04-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208303-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2022-02-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208303-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2022-02-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208303-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2022-02-10 4b0b4de00fa7…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208303-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2022-02-10 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208303-002 ROFLUMILAST 250MCG TABLET / ORAL AB 2023-04-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208303-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2022-02-10 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A208303-002 ROFLUMILAST 250MCG TABLET / ORAL AB 2023-04-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208303-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2022-02-10 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A208303-002 ROFLUMILAST 250MCG TABLET / ORAL AB 2023-04-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208303-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2022-02-10 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208303-002 ROFLUMILAST 250MCG TABLET / ORAL AB 2023-04-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208303-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2022-02-10 9b2671bbb829…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 52 observed states.
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 · 2 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 68382-969-06 Roflumilast 30 in 1 BOTTLE TABLET 30 3 68382-969-16 Roflumilast 90 in 1 BOTTLE TABLET 90 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68382-969 ROFLUMILAST TABLET [ZYDUS PHARMACEUTICALS USA INC.] 3 Current NDC, Legacy NDC, 2 package rows 20240821_84145572-f320-4c3f-ab29-bd9f6c18746c.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 68382-969-06 68382096906 30 TABLET in 1 BOTTLE (68382-969-06) 30 tablet 2022-10-03 0000-00-00 No No Current 68382-969-16 68382096916 90 TABLET in 1 BOTTLE (68382-969-16) 90 tablet 2022-10-03 0000-00-00 No No Current