Nifedipine

Product NDC
63629-7215
11-digit product format
636297215
Labeler code
63629
Product ID
63629-7215_0c142e3d-1848-455f-8614-4e2a001383f5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nifedipine
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA072556
Marketing category
ANDA
Marketing start
1990-09-20
Marketing end
0000-00-00
Substance
NIFEDIPINE
Active strength
20 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63629-7215DDiscontinued by firm2026-08-03
excluded packagepackage63629-721563629-7215-1DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 26 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-7215-1DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-7215-1DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-7215-1DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-7215-1DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-7215-1DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-7215-1DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-7215-1DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-7215-1DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63629-7215-1DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63629-7215-1DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63629-7215-1DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63629-7215-1DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63629-7215-1IInactivated by FDA9bebd1f3094a…5416666fcb17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A072556-001NIFEDIPINENIFEDIPINE20MGCAPSULE / ORAL1990-09-20

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A072556-001NIFEDIPINE20MGCAPSULE / ORAL1990-09-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072556-001NIFEDIPINE20MGCAPSULE / ORAL1990-09-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A072556-001NIFEDIPINE20MGCAPSULE / ORAL1990-09-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072556-001NIFEDIPINE20MGCAPSULE / ORAL1990-09-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072556-001NIFEDIPINE20MGCAPSULE / ORAL1990-09-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072556-001NIFEDIPINE20MGCAPSULE / ORAL1990-09-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072556-001NIFEDIPINE20MGCAPSULE / ORAL1990-09-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072556-001NIFEDIPINE20MGCAPSULE / ORAL1990-09-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072556-001NIFEDIPINE20MGCAPSULE / ORAL1990-09-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A072556-001NIFEDIPINE20MGCAPSULE / ORAL1990-09-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072556-001NIFEDIPINE20MGCAPSULE / ORALAB1990-09-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072556-001NIFEDIPINE20MGCAPSULE / ORALAB1990-09-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A072556-001NIFEDIPINE20MGCAPSULE / ORALAB1990-09-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A072556-001NIFEDIPINE20MGCAPSULE / ORALAB1990-09-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A072556-001NIFEDIPINE20MGCAPSULE / ORALAB1990-09-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A072556-001NIFEDIPINE20MGCAPSULE / ORALAB1990-09-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A072556-001NIFEDIPINE20MGCAPSULE / ORALAB1990-09-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A072556-001NIFEDIPINE20MGCAPSULE / ORALAB1990-09-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A072556-001NIFEDIPINE20MGCAPSULE / ORALAB1990-09-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A072556-001NIFEDIPINE20MGCAPSULE / ORALAB1990-09-20782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A072556-001NIFEDIPINE20MGCAPSULE / ORALAB1990-09-2087673890dc5c…
2021-03-12 10:30 UTC2021-03A072556-001NIFEDIPINE20MGCAPSULE / ORALAB1990-09-205aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A072556-001NIFEDIPINE20MGCAPSULE / ORALAB1990-09-208869cabd3fbd…
2020-11-12 02:37 UTC2020-11A072556-001NIFEDIPINE20MGCAPSULE / ORALAB1990-09-20c0c555d07b60…
2019-12-14 00:12 UTC2019-12A072556-001NIFEDIPINE20MGCAPSULE / ORALAB1990-09-203f01610625f2…
2019-09-15 20:21 UTC2019-09A072556-001NIFEDIPINE20MGCAPSULE / ORALAB1990-09-20b00525d2431f…
2019-07-19 19:46 UTC2019-07A072556-001NIFEDIPINE20MGCAPSULE / ORALAB1990-09-20ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A072556-001NIFEDIPINE20MGCAPSULE / ORALAB1990-09-206a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A072556-001NIFEDIPINE20MGCAPSULE / ORALAB1990-09-201c564ffb4f44…
2023-12-20 04:57 UTC2023-12A072556-001NIFEDIPINE20MGCAPSULE / ORALAB1990-09-20ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A072556-001NIFEDIPINE20MGCAPSULE / ORALAB1990-09-20a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A072556-001NIFEDIPINE20MGCAPSULE / ORALAB1990-09-209b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A072556-001NIFEDIPINE20MGCAPSULE / ORALAB1990-09-20a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A072556-001NIFEDIPINE20MGCAPSULE / ORALAB1990-09-203f0d92c62455…
2023-05-13 08:27 UTC2023-05A072556-001NIFEDIPINE20MGCAPSULE / ORALAB1990-09-20053a50430f4f…
2023-01-26 05:58 UTC2023-01A072556-001NIFEDIPINE20MGCAPSULE / ORALAB1990-09-203bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A072556-001NIFEDIPINE20MGCAPSULE / ORALAB1990-09-203a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A072556-001NIFEDIPINE20MGCAPSULE / ORALAB1990-09-20f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A072556-001NIFEDIPINE20MGCAPSULE / ORALAB1990-09-20e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A072556-001NIFEDIPINE20MGCAPSULE / ORALAB1990-09-20cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072556-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072556-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A072556-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A072556-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A072556-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A072556-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A072556-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A072556-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A072556-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A072556-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A072556-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A072556-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A072556-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A072556-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A072556-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A072556-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A072556-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A072556-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A072556-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A072556-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A072556-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A072556-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A072556-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A072556-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A072556-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A072556-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A072556-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A072556-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A072556-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A072556-001AB1cb3db0bc1861…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-7215-12020-10-16C16284748780-19d75b9d0-0685-f424-e053-dadaa90a57ceNIFEDIPINE CAPSULES, USP
63629-7215-12020-01-31C16284748780-19d75b9d0-0685-f424-e053-dadaa90a57ceNIFEDIPINE CAPSULES, USP

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-7215-16362972150130 CAPSULE, LIQUID FILLED in 1 BOTTLE (63629-7215-1) 2017-03-150000-00-00NoNoCurrent