Nifedipine

Product NDC
21695-909
11-digit product format
216950909
Labeler code
21695
Product ID
21695-909_6fafbe75-fcae-4afd-9745-02e641cefb31
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nifedipine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA077899
Marketing category
ANDA
Marketing start
2006-12-13
Marketing end
0000-00-00
Substance
NIFEDIPINE
Active strength
60 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
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 productproduct21695-909IInactivated by FDA2026-08-03
excluded packagepackage21695-90921695-909-30IInactivated by FDA2026-08-03

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-909-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-909-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-909-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-909-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-909-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-909-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-909-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-909-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-909-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage21695-909-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage21695-909-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage21695-909-30557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage21695-909-308af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage21695-909-30834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage21695-909-301332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage21695-909-30fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage21695-909-3086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage21695-909-30bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage21695-909-308dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage21695-909-30e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage21695-909-309bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage21695-909-30110d247fa046…a55b01930146…

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077899-001NIFEDIPINENIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORAL2006-12-13
A077899-002NIFEDIPINENIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORAL2006-12-13
A077899-003NIFEDIPINENIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORAL2012-05-25

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077899-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORAL2006-12-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077899-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORAL2006-12-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077899-003NIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORAL2012-05-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077899-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORAL2006-12-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077899-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORAL2006-12-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077899-003NIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORAL2012-05-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A077899-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORAL2006-12-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077899-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORAL2006-12-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077899-003NIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORAL2012-05-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077899-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORAL2006-12-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077899-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORAL2006-12-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077899-003NIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORAL2012-05-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077899-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORAL2006-12-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077899-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORAL2006-12-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077899-003NIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORAL2012-05-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077899-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORAL2006-12-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077899-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORAL2006-12-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077899-003NIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORAL2012-05-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077899-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORAL2006-12-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077899-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORAL2006-12-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077899-003NIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORAL2012-05-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077899-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORAL2006-12-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077899-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORAL2006-12-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077899-003NIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORAL2012-05-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077899-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORAL2006-12-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077899-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORAL2006-12-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077899-003NIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORAL2012-05-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077899-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORAL2006-12-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A077899-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORAL2006-12-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A077899-003NIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORAL2012-05-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077899-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORAL2006-12-1379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077899-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORAL2006-12-1379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077899-003NIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORAL2012-05-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077899-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORAL2006-12-13301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077899-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORAL2006-12-13301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077899-003NIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORAL2012-05-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077899-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORAL2006-12-131e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077899-002NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORAL2006-12-131e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077899-003NIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORAL2012-05-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077899-001NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORAL2006-12-138072bd15b7f6…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A077899-001AB1174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077899-002AB1174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077899-003AB1174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077899-001AB1187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077899-002AB1187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077899-003AB1187673890dc5c…
2021-03-12 10:30 UTC2021-03A077899-001AB115aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A077899-002AB115aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A077899-003AB115aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077899-001AB118869cabd3fbd…
2020-12-22 03:56 UTC2020-12A077899-002AB118869cabd3fbd…
2020-12-22 03:56 UTC2020-12A077899-003AB118869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077899-001AB11c0c555d07b60…
2020-11-12 02:37 UTC2020-11A077899-002AB11c0c555d07b60…
2020-11-12 02:37 UTC2020-11A077899-003AB11c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077899-001AB113f01610625f2…
2019-12-14 00:12 UTC2019-12A077899-002AB113f01610625f2…
2019-12-14 00:12 UTC2019-12A077899-003AB113f01610625f2…
2019-09-15 20:21 UTC2019-09A077899-001AB11b00525d2431f…
2019-09-15 20:21 UTC2019-09A077899-002AB11b00525d2431f…
2019-09-15 20:21 UTC2019-09A077899-003AB11b00525d2431f…
2019-07-19 19:46 UTC2019-07A077899-001AB11ea99ee380514…
2019-07-19 19:46 UTC2019-07A077899-002AB11ea99ee380514…
2019-07-19 19:46 UTC2019-07A077899-003AB11ea99ee380514…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bbd94e90-e531-9113-45c1-29860f331640Product name720230104
5e4d0a9b-8ce4-418c-bf0c-d2b4be281ffdProduct name420220126
308fd2ea-d88a-e021-96c1-7c2ab74d6e4bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-909-302019-09-24C16284748780-1934fe258-48a5-48b1-e053-8cdaa90a720aNifedipine Extended-Release Tablets For Oral Use

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-909-30Nifedipine30 in 1 BOTTLETABLET, EXTENDED RELEASE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-909-30EA - Each21695-909569c05e0-645c-4e05-add9-deca0d5bb15c12012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-909NIFEDIPINE TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20110113_6fafbe75-fcae-4afd-9745-02e641cefb31.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198035NIFEdipine 60 MG 24HR Extended Release Oral TabletPSN6fafbe75-fcae-4afd-9745-02e641cefb311
19803524 HR nifedipine 60 MG Extended Release Oral TabletSCD6fafbe75-fcae-4afd-9745-02e641cefb311
198035nifedipine 60 MG 24 HR Extended Release Oral TabletSY6fafbe75-fcae-4afd-9745-02e641cefb311

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-909-302169509093030 in 1 BOTTLEHistorical