Home NDC 13668-476 Roflumilast
Product NDC 13668-476
11-digit product format 136680476
Labeler code 13668
Product ID 13668-476_eea14f4b-9ed6-1c0e-e053-2a95a90afb85
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Roflumilast
Dosage form TABLET
Route ORAL
Labeler Torrent Pharmaceuticals Limited
Application ANDA208272
Marketing category ANDA
Marketing start 2022-10-19
Marketing end 0000-00-00
Substance ROFLUMILAST
Active strength 500 ug/1
Pharmacologic classes Phosphodiesterase 4 Inhibitor [EPC], Phosphodiesterase 4 Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 A208272-001 ROFLUMILAST ROFLUMILAST 500MCG TABLET / ORAL 2018-08-06 A208272-002 ROFLUMILAST ROFLUMILAST 250MCG TABLET / ORAL 2024-10-18
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 2024-10-29 15:01 UTC 2024-10 A208272-001 ROFLUMILAST 500MCG TABLET / ORAL 2018-08-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208272-001 ROFLUMILAST 500MCG TABLET / ORAL 2018-08-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208272-001 ROFLUMILAST 500MCG TABLET / ORAL 2018-08-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208272-001 ROFLUMILAST 500MCG TABLET / ORAL 2018-08-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208272-001 ROFLUMILAST 500MCG TABLET / ORAL 2018-08-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208272-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2018-08-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208272-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2018-08-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208272-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2018-08-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A208272-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2018-08-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A208272-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2018-08-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208272-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2018-08-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208272-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2018-08-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A208272-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2018-08-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A208272-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2018-08-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A208272-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2018-08-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A208272-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2018-08-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A208272-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2018-08-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A208272-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2018-08-06 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208272-001 ROFLUMILAST 500MCG TABLET / ORAL 2018-08-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208272-001 ROFLUMILAST 500MCG TABLET / ORAL 2018-08-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208272-001 ROFLUMILAST 500MCG TABLET / ORAL 2018-08-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208272-001 ROFLUMILAST 500MCG TABLET / ORAL 2018-08-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208272-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2018-08-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A208272-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2018-08-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A208272-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2018-08-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A208272-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2018-08-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A208272-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2018-08-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A208272-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2018-08-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A208272-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2018-08-06 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A208272-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2018-08-06 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A208272-001 ROFLUMILAST 500MCG TABLET / ORAL AB 2018-08-06 cb3db0bc1861…2026-08-01 22:54:32 2026-06 A208272-001 ROFLUMILAST 500MCG TABLET / ORAL 2018-08-06 a50c72e98297…2026-08-01 22:54:32 2026-06 A208272-002 ROFLUMILAST 250MCG TABLET / ORAL 2024-10-18 a50c72e98297…
Observed Orange Book normalized TE history# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 13668-476-05 13668047605 500 TABLET in 1 BOTTLE (13668-476-05) 500 tablet 2022-10-19 0000-00-00 No No Current 13668-476-30 13668047630 30 TABLET in 1 BOTTLE (13668-476-30) 30 tablet 2022-10-19 0000-00-00 No No Current 13668-476-74 13668047674 100 TABLET in 1 CARTON (13668-476-74) 100 tablet 2022-10-19 0000-00-00 No No Current 13668-476-90 13668047690 90 TABLET in 1 BOTTLE (13668-476-90) 90 tablet 2022-10-19 0000-00-00 No No Current