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 43 .
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 · 57 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 2026-09-14 22:38:34 2026-08 A208303-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2022-02-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208303-002 ROFLUMILAST 250MCG TABLET / ORAL AB 2023-04-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 A208303-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2022-02-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208303-002 ROFLUMILAST 250MCG TABLET / ORAL AB 2023-04-18 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 56 observed states.
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
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
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