Home NDC 43547-005 ROFLUMILAST
Product NDC 43547-005
11-digit product format 435470005
Labeler code 43547
Product ID 43547-005_4251c764-7224-4f94-9de7-b6c76cb1f5cd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name roflumilast
Dosage form TABLET
Route ORAL
Labeler Solco Healthcare US, LLC.
Application ANDA208299
Marketing category ANDA
Marketing start 2022-05-10
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 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A208299-001 ROFLUMILAST ROFLUMILAST 500MCG TABLET / ORAL AB 2022-05-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A208299-001 AB
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 2026-08-18 06:07:40 2026-07 A208299-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2022-05-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208299-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2022-05-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208299-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2022-05-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208299-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2022-05-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208299-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2022-05-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208299-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2022-05-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208299-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2022-05-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208299-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2022-05-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208299-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2022-05-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208299-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2022-05-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208299-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2022-05-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208299-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2022-05-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208299-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2022-05-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208299-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2022-05-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208299-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2022-05-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208299-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2022-05-10 5c6f7cd8ea54…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208299-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2022-05-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208299-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2022-05-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208299-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2022-05-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208299-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2022-05-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208299-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2022-05-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A208299-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2022-05-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A208299-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2022-05-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A208299-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2022-05-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A208299-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2022-05-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A208299-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2022-05-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A208299-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2022-05-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A208299-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2022-05-10 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A208299-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2022-05-10 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A208299-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2022-05-10 a50c72e98297…
Observed Orange Book normalized TE history# 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1091839 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 43547-005-03 ROFLUMILAST 30 in 1 BOTTLE TABLET 30 1 43547-005-09 ROFLUMILAST 90 in 1 BOTTLE TABLET 90 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43547-005 ROFLUMILAST TABLET [SOLCO HEALTHCARE US, LLC.] 1 Current NDC, Legacy NDC, 2 package rows 20220731_4251c764-7224-4f94-9de7-b6c76cb1f5cd.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 · 1 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 43547-005-03 43547000503 30 TABLET in 1 BOTTLE (43547-005-03) 30 tablet 2022-05-10 0000-00-00 No No Current 43547-005-09 43547000509 90 TABLET in 1 BOTTLE (43547-005-09) 90 tablet 2022-05-10 0000-00-00 No No Current