Home NDC 73190-087 roflumilast
Product NDC 73190-087
11-digit product format 731900087
Labeler code 73190
Product ID 73190-087_5500b154-77bd-3d4a-e063-6394a90ade49
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ROFLUMILAST
Dosage form TABLET
Route ORAL
Labeler AvKARE
Application ANDA208247
Marketing category ANDA
Marketing start 2026-06-24
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 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 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.
Product history page 1 of 2 · 62 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 A208247-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2020-03-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208247-002 ROFLUMILAST 250MCG TABLET / ORAL AB 2023-06-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 A208247-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2020-03-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208247-002 ROFLUMILAST 250MCG TABLET / ORAL AB 2023-06-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208247-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2020-03-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208247-002 ROFLUMILAST 250MCG TABLET / ORAL AB 2023-06-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208247-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2020-03-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208247-002 ROFLUMILAST 250MCG TABLET / ORAL AB 2023-06-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208247-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2020-03-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208247-002 ROFLUMILAST 250MCG TABLET / ORAL AB 2023-06-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208247-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2020-03-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208247-002 ROFLUMILAST 250MCG TABLET / ORAL AB 2023-06-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208247-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2020-03-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208247-002 ROFLUMILAST 250MCG TABLET / ORAL AB 2023-06-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208247-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2020-03-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208247-002 ROFLUMILAST 250MCG TABLET / ORAL AB 2023-06-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208247-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2020-03-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208247-002 ROFLUMILAST 250MCG TABLET / ORAL AB 2023-06-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208247-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2020-03-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208247-002 ROFLUMILAST 250MCG TABLET / ORAL AB 2023-06-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208247-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2020-03-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208247-002 ROFLUMILAST 250MCG TABLET / ORAL AB 2023-06-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208247-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2020-03-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208247-002 ROFLUMILAST 250MCG TABLET / ORAL AB 2023-06-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208247-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2020-03-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208247-002 ROFLUMILAST 250MCG TABLET / ORAL AB 2023-06-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208247-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2020-03-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208247-002 ROFLUMILAST 250MCG TABLET / ORAL AB 2023-06-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208247-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2020-03-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208247-002 ROFLUMILAST 250MCG TABLET / ORAL AB 2023-06-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208247-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2020-03-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A208247-002 ROFLUMILAST 250MCG TABLET / ORAL AB 2023-06-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208247-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2020-03-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208247-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2020-03-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208247-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2020-03-30 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A208247-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2020-03-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208247-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2020-03-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208247-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2020-03-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A208247-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2020-03-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A208247-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2020-03-30 8869cabd3fbd…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 62 observed states.
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2023-12-20 04:57 UTC 2023-12 A208247-001 PC 2023-04-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208247-001 PC 2023-04-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208247-001 PC 2023-04-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A208247-001 PC 2023-04-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A208247-001 PC 2023-04-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A208247-001 PC 2023-04-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A208247-001 PC 2023-04-17 3bdfa0b2c4d7…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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
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.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 73190-087-30 73190008730 30 TABLET in 1 BOTTLE (73190-087-30) 30 tablet 2026-06-24 No No Current 73190-087-90 73190008790 90 TABLET in 1 BOTTLE (73190-087-90) 90 tablet 2026-06-24 No No Current