nifedipine

Product NDC
67046-515
11-digit product format
670460515
Labeler code
67046
Product ID
67046-515_43062486-bbac-47e4-bae1-16924338c8d8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nifedipine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
NDA019684
Marketing category
NDA
Marketing start
2010-04-13
Marketing end
0000-00-00
Substance
NIFEDIPINE
Active strength
30 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 productproduct67046-515IInactivated by FDA2026-10-12
excluded packagepackage67046-51567046-515-30IInactivated by FDA2026-10-12

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 packagepackage67046-515-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67046-515-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67046-515-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67046-515-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67046-515-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67046-515-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67046-515-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67046-515-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67046-515-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage67046-515-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage67046-515-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67046-515-30557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage67046-515-308af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage67046-515-30834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage67046-515-301332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage67046-515-30fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage67046-515-3086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage67046-515-30bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage67046-515-308dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage67046-515-30e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage67046-515-309bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage67046-515-30110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N019684-001PROCARDIA XLNIFEDIPINE30MGTABLET, EXTENDED RELEASE / ORALAB2RLD1989-09-06
N019684-002PROCARDIA XLNIFEDIPINE60MGTABLET, EXTENDED RELEASE / ORALAB2RLD1989-09-06
N019684-003PROCARDIA XLNIFEDIPINE90MGTABLET, EXTENDED RELEASE / ORALRLD1989-09-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N019684-001AB2
N019684-002AB2

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 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N019684-001PROCARDIA XL30MGTABLET, EXTENDED RELEASE / ORALAB2RLD1989-09-0684e616aacf4f…
2026-09-14 22:38:342026-08N019684-002PROCARDIA XL60MGTABLET, EXTENDED RELEASE / ORALAB2RLD1989-09-0684e616aacf4f…
2026-09-14 22:38:342026-08N019684-003PROCARDIA XL90MGTABLET, EXTENDED RELEASE / ORALRLD1989-09-0684e616aacf4f…
2026-08-18 06:07:402026-07N019684-001PROCARDIA XL30MGTABLET, EXTENDED RELEASE / ORALAB2RLD1989-09-06caaa826d4ba7…
2026-08-18 06:07:402026-07N019684-002PROCARDIA XL60MGTABLET, EXTENDED RELEASE / ORALAB2RLD1989-09-06caaa826d4ba7…
2026-08-18 06:07:402026-07N019684-003PROCARDIA XL90MGTABLET, EXTENDED RELEASE / ORALRLD1989-09-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019684-001PROCARDIA XL30MGTABLET, EXTENDED RELEASE / ORALAB2RLD1989-09-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019684-002PROCARDIA XL60MGTABLET, EXTENDED RELEASE / ORALAB2RLD1989-09-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019684-003PROCARDIA XL90MGTABLET, EXTENDED RELEASE / ORALAB2RLD, RS1989-09-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019684-001PROCARDIA XL30MGTABLET, EXTENDED RELEASE / ORALAB2RLD1989-09-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019684-002PROCARDIA XL60MGTABLET, EXTENDED RELEASE / ORALAB2RLD1989-09-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019684-003PROCARDIA XL90MGTABLET, EXTENDED RELEASE / ORALAB2RLD, RS1989-09-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08N019684-001PROCARDIA XL30MGTABLET, EXTENDED RELEASE / ORALAB2RLD1989-09-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019684-002PROCARDIA XL60MGTABLET, EXTENDED RELEASE / ORALAB2RLD1989-09-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019684-003PROCARDIA XL90MGTABLET, EXTENDED RELEASE / ORALAB2RLD, RS1989-09-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019684-001PROCARDIA XL30MGTABLET, EXTENDED RELEASE / ORALAB2RLD1989-09-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019684-002PROCARDIA XL60MGTABLET, EXTENDED RELEASE / ORALAB2RLD1989-09-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019684-003PROCARDIA XL90MGTABLET, EXTENDED RELEASE / ORALAB2RLD, RS1989-09-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019684-001PROCARDIA XL30MGTABLET, EXTENDED RELEASE / ORALAB2RLD1989-09-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019684-002PROCARDIA XL60MGTABLET, EXTENDED RELEASE / ORALAB2RLD1989-09-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019684-003PROCARDIA XL90MGTABLET, EXTENDED RELEASE / ORALAB2RLD, RS1989-09-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019684-001PROCARDIA XL30MGTABLET, EXTENDED RELEASE / ORALAB2RLD1989-09-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019684-002PROCARDIA XL60MGTABLET, EXTENDED RELEASE / ORALAB2RLD1989-09-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019684-003PROCARDIA XL90MGTABLET, EXTENDED RELEASE / ORALAB2RLD, RS1989-09-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019684-001PROCARDIA XL30MGTABLET, EXTENDED RELEASE / ORALAB2RLD1989-09-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019684-002PROCARDIA XL60MGTABLET, EXTENDED RELEASE / ORALAB2RLD1989-09-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019684-003PROCARDIA XL90MGTABLET, EXTENDED RELEASE / ORALAB2RLD, RS1989-09-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019684-001PROCARDIA XL30MGTABLET, EXTENDED RELEASE / ORALAB2RLD1989-09-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019684-002PROCARDIA XL60MGTABLET, EXTENDED RELEASE / ORALAB2RLD1989-09-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019684-003PROCARDIA XL90MGTABLET, EXTENDED RELEASE / ORALAB2RLD, RS1989-09-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019684-001PROCARDIA XL30MGTABLET, EXTENDED RELEASE / ORALAB2RLD1989-09-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019684-002PROCARDIA XL60MGTABLET, EXTENDED RELEASE / ORALAB2RLD1989-09-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019684-003PROCARDIA XL90MGTABLET, EXTENDED RELEASE / ORALAB2RLD, RS1989-09-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019684-001PROCARDIA XL30MGTABLET, EXTENDED RELEASE / ORALAB2RLD1989-09-06d06236e962d9…
2024-10-29 15:01 UTC2024-10N019684-002PROCARDIA XL60MGTABLET, EXTENDED RELEASE / ORALAB2RLD1989-09-06d06236e962d9…
2024-10-29 15:01 UTC2024-10N019684-003PROCARDIA XL90MGTABLET, EXTENDED RELEASE / ORALAB2RLD, RS1989-09-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019684-001PROCARDIA XL30MGTABLET, EXTENDED RELEASE / ORALAB2RLD1989-09-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019684-002PROCARDIA XL60MGTABLET, EXTENDED RELEASE / ORALAB2RLD1989-09-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019684-003PROCARDIA XL90MGTABLET, EXTENDED RELEASE / ORALAB2RLD, RS1989-09-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019684-001PROCARDIA XL30MGTABLET, EXTENDED RELEASE / ORALAB2RLD1989-09-06301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N019684-001AB2184e616aacf4f…
2026-09-14 22:38:342026-08N019684-002AB2184e616aacf4f…
2026-08-18 06:07:402026-07N019684-001AB21caaa826d4ba7…
2026-08-18 06:07:402026-07N019684-002AB21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019684-001AB21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019684-002AB21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019684-003AB21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019684-001AB2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019684-002AB2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019684-003AB2131067a03dcf5…
2025-08-23 18:47 UTC2025-08N019684-001AB216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019684-002AB216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019684-003AB216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019684-001AB21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019684-002AB21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019684-003AB21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019684-001AB21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019684-002AB21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019684-003AB21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019684-001AB2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019684-002AB2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019684-003AB2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019684-001AB212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019684-002AB212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019684-003AB212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019684-001AB215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019684-002AB215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019684-003AB215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019684-001AB21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019684-002AB21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019684-003AB21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019684-001AB21d06236e962d9…
2024-10-29 15:01 UTC2024-10N019684-002AB21d06236e962d9…
2024-10-29 15:01 UTC2024-10N019684-003AB21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019684-001AB2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019684-002AB2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019684-003AB2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019684-001AB21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019684-002AB21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019684-003AB21301d65b070ca…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
67046-515-302019-10-21C16284748780-1956f9ecf-c6d2-621f-e053-dbdaa90a74adNIFEDIPINE EXTENDED-RELEASE TABLETS 30 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-515-30nifedipine30 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
nifedipineACTIVE INGREDIENTI9ZF7L6G2LNIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [CONTRACT PHARMACY SERVICES-PA]1
nifedipineACTIVE MOIETYI9ZF7L6G2LNIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [CONTRACT PHARMACY SERVICES-PA]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-515NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 1 package rows20100413_43062486-bbac-47e4-bae1-16924338c8d8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1812011NIFEdipine 30 MG Osmotic 24HR Extended Release Oral TabletPSN43062486-bbac-47e4-bae1-16924338c8d81
1812011Osmotic 24 HR nifedipine 30 MG Extended Release Oral TabletSCD43062486-bbac-47e4-bae1-16924338c8d81
1812011nifedipine 30 MG Osmotic 24 HR Extended Release Oral TabletSY43062486-bbac-47e4-bae1-16924338c8d81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67046-515-306704605153030 in 1 BLISTER PACKHistorical