Nifedipine

Product NDC
50090-2939
11-digit product format
500902939
Labeler code
50090
Product ID
50090-2939_12923300-bdf2-49b0-b624-2f02c855b7d7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nifedipine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA075289
Marketing category
ANDA
Marketing start
2000-12-11
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
No
Listing certified through
2019-12-31
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 productproduct50090-2939IInactivated by FDA2026-08-07
excluded packagepackage50090-293950090-2939-2IInactivated by FDA2026-08-07

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 · 42 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 packagepackage50090-2939-2d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-2939-2f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-2939-22ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-2939-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-2939-2cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-2939-2cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-2939-2302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-2939-2ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-2939-20efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-2939-2ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-2939-2367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-2939-2557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50090-2939-28af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50090-2939-2834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50090-2939-21332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage50090-2939-2fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage50090-2939-286f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage50090-2939-2bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage50090-2939-28dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage50090-2939-2e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage50090-2939-29bebd1f3094a…5416666fcb17…

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
A075289-001NIFEDIPINENIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22000-09-27
A075289-002NIFEDIPINENIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22001-02-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A075289-001AB2
A075289-002AB2

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A075289-001NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22000-09-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075289-002NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22001-02-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075289-001NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22000-09-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075289-002NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22001-02-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A075289-001NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22000-09-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075289-002NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22001-02-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075289-001NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22000-09-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075289-002NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22001-02-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075289-001NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22000-09-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075289-002NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22001-02-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075289-001NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22000-09-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075289-002NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22001-02-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075289-001NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22000-09-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075289-002NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22001-02-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075289-001NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22000-09-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075289-002NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22001-02-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075289-001NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22000-09-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075289-002NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22001-02-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075289-001NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22000-09-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A075289-002NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22001-02-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075289-001NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22000-09-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075289-002NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22001-02-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075289-001NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22000-09-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075289-002NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22001-02-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075289-001NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22000-09-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075289-002NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22001-02-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075289-001NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22000-09-278072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075289-002NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22001-02-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075289-001NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22000-09-275c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075289-002NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22001-02-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075289-001NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22000-09-275d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075289-002NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22001-02-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075289-001NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22000-09-274b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075289-002NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22001-02-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075289-001NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22000-09-2774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075289-002NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22001-02-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075289-001NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22000-09-27bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075289-002NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22001-02-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075289-001NIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB22000-09-27782e0a99824c…
2021-12-28 21:50 UTC2021-12A075289-002NIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB22001-02-06782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A075289-001AB21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075289-002AB21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075289-001AB2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075289-002AB2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075289-001AB216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075289-002AB216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075289-001AB21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075289-002AB21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075289-001AB21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075289-002AB21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075289-001AB2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075289-002AB2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075289-001AB212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075289-002AB212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075289-001AB215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075289-002AB215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075289-001AB21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075289-002AB21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075289-001AB21d06236e962d9…
2024-10-29 15:01 UTC2024-10A075289-002AB21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075289-001AB2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075289-002AB2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075289-001AB21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075289-002AB21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075289-001AB211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075289-002AB211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075289-001AB218072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075289-002AB218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075289-001AB215c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075289-002AB215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075289-001AB215d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075289-002AB215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075289-001AB214b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075289-002AB214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075289-001AB2174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075289-002AB2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075289-001AB21bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075289-002AB21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075289-001AB21782e0a99824c…
2021-12-28 21:50 UTC2021-12A075289-002AB21782e0a99824c…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
50090-2939-22020-01-31C16284748780-19d75b9d0-ed5e-f424-e053-dadaa90a57ceNifedipine Extended-Release Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2939-2Nifedipine90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2939NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]2Legacy NDC, 1 package rows20180302_159c6dfd-aaba-4643-8abe-7b83f1adf255.zip

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
nifedipineNIFEDIPINEBryant Ranch Prepackd7475c68-6310-4b9a-81c1-9209a9ade75f2026-06-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075289
application number: ANDA075289
nifedipineNIFEDIPINEOceanside Pharmaceuticalsc7874606-c71e-424c-b881-38697988e0d02026-02-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075289
application number: ANDA075289

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1812013NIFEdipine 60 MG Osmotic 24HR Extended Release Oral TabletPSN159c6dfd-aaba-4643-8abe-7b83f1adf2552
1812013Osmotic 24 HR nifedipine 60 MG Extended Release Oral TabletSCD159c6dfd-aaba-4643-8abe-7b83f1adf2552
1812013nifedipine 60 MG Osmotic 24 HR Extended Release Oral TabletSY159c6dfd-aaba-4643-8abe-7b83f1adf2552

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50090-2939-25009029390290 in 1 BOTTLEHistorical