FDA.reportPublic FDA data

Roflumilast

Product NDC
13668-476
Requested package NDC
13668-476-90
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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage13668-47613668-476-90DDiscontinued by firm2026-08-03

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A208272-001ROFLUMILASTROFLUMILAST500MCGTABLET / ORAL2018-08-06
A208272-002ROFLUMILASTROFLUMILAST250MCGTABLET / ORAL2024-10-18

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.

Product history page 1 of 2 · 50 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A208272-001ROFLUMILAST500MCGTABLET / ORAL2018-08-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208272-002ROFLUMILAST250MCGTABLET / ORAL2024-10-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208272-001ROFLUMILAST500MCGTABLET / ORAL2018-08-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208272-002ROFLUMILAST250MCGTABLET / ORAL2024-10-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A208272-001ROFLUMILAST500MCGTABLET / ORAL2018-08-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208272-002ROFLUMILAST250MCGTABLET / ORALAB2024-10-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208272-001ROFLUMILAST500MCGTABLET / ORAL2018-08-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208272-002ROFLUMILAST250MCGTABLET / ORALAB2024-10-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208272-001ROFLUMILAST500MCGTABLET / ORAL2018-08-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208272-002ROFLUMILAST250MCGTABLET / ORALAB2024-10-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208272-001ROFLUMILAST500MCGTABLET / ORAL2018-08-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208272-002ROFLUMILAST250MCGTABLET / ORALAB2024-10-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208272-001ROFLUMILAST500MCGTABLET / ORAL2018-08-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208272-002ROFLUMILAST250MCGTABLET / ORALAB2024-10-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208272-001ROFLUMILAST500MCGTABLET / ORAL2018-08-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208272-001ROFLUMILAST500MCGTABLET / ORAL2018-08-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208272-002ROFLUMILAST250MCGTABLET / ORALAB2024-10-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208272-001ROFLUMILAST500MCGTABLET / ORAL2018-08-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208272-001ROFLUMILAST500MCGTABLET / ORAL2018-08-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208272-001ROFLUMILAST500MCGTABLET / ORAL2018-08-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208272-001ROFLUMILAST500MCGTABLET / ORAL2018-08-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208272-001ROFLUMILAST500MCGTABLET / ORAL2018-08-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208272-001ROFLUMILAST500MCGTABLET / ORALAB2018-08-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208272-001ROFLUMILAST500MCGTABLET / ORALAB2018-08-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208272-001ROFLUMILAST500MCGTABLET / ORALAB2018-08-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208272-001ROFLUMILAST500MCGTABLET / ORALAB2018-08-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208272-001ROFLUMILAST500MCGTABLET / ORALAB2018-08-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208272-001ROFLUMILAST500MCGTABLET / ORALAB2018-08-06782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208272-001ROFLUMILAST500MCGTABLET / ORALAB2018-08-0687673890dc5c…
2021-03-12 10:30 UTC2021-03A208272-001ROFLUMILAST500MCGTABLET / ORALAB2018-08-065aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208272-001ROFLUMILAST500MCGTABLET / ORALAB2018-08-068869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208272-001ROFLUMILAST500MCGTABLET / ORALAB2018-08-06c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208272-001ROFLUMILAST500MCGTABLET / ORALAB2018-08-063f01610625f2…
2019-09-15 20:21 UTC2019-09A208272-001ROFLUMILAST500MCGTABLET / ORALAB2018-08-06b00525d2431f…
2019-07-19 19:46 UTC2019-07A208272-001ROFLUMILAST500MCGTABLET / ORALAB2018-08-06ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208272-001ROFLUMILAST500MCGTABLET / ORAL2018-08-066a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208272-001ROFLUMILAST500MCGTABLET / ORAL2018-08-061c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208272-001ROFLUMILAST500MCGTABLET / ORAL2018-08-06ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208272-001ROFLUMILAST500MCGTABLET / ORAL2018-08-06a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208272-001ROFLUMILAST500MCGTABLET / ORALAB2018-08-069b2671bbb829…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-08-23 18:47 UTC2025-08A208272-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208272-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208272-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208272-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208272-002AB12680178bc6a6…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208272-002AB1d8e5a09893c0…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208272-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208272-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208272-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208272-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208272-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208272-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208272-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A208272-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208272-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208272-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208272-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A208272-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A208272-001AB1ea99ee380514…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208272-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208272-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208272-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A208272-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A208272-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208272-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208272-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A208272-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A208272-001AB1cb3db0bc1861…

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13668-476-901366804769090 TABLET in 1 BOTTLE (13668-476-90) 90 tablet2022-10-190000-00-00NoNoCurrent