Nifedipine

Product NDC
43386-440
11-digit product format
433860440
Labeler code
43386
Product ID
43386-440_75c72876-28a3-5fc5-e053-2a91aa0acc70
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nifedipine
Dosage form
CAPSULE
Route
ORAL
Labeler
Lupin Pharmaceuticals Inc
Application
ANDA072781
Marketing category
ANDA
Marketing start
2009-08-11
Marketing end
0000-00-00
Substance
NIFEDIPINE
Active strength
10 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 productproduct43386-440IInactivated by FDA2026-08-10
excluded packagepackage43386-44043386-440-24IInactivated by FDA2026-08-10

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 packagepackage43386-440-24d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43386-440-24f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43386-440-242ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43386-440-24a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43386-440-24cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43386-440-24cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage43386-440-24302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage43386-440-24ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage43386-440-240efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage43386-440-24ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage43386-440-24367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage43386-440-24557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage43386-440-248af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage43386-440-24834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage43386-440-241332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage43386-440-24fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage43386-440-2486f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage43386-440-24bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage43386-440-248dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage43386-440-24e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage43386-440-249bebd1f3094a…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
A072781-001NIFEDIPINENIFEDIPINE10MGCAPSULE / ORALAB1993-07-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A072781-001AB

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 UTC2026-02A072781-001NIFEDIPINE10MGCAPSULE / ORALAB1993-07-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072781-001NIFEDIPINE10MGCAPSULE / ORALAB1993-07-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A072781-001NIFEDIPINE10MGCAPSULE / ORALAB1993-07-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072781-001NIFEDIPINE10MGCAPSULE / ORALAB1993-07-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072781-001NIFEDIPINE10MGCAPSULE / ORALAB1993-07-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072781-001NIFEDIPINE10MGCAPSULE / ORALAB1993-07-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072781-001NIFEDIPINE10MGCAPSULE / ORALAB1993-07-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072781-001NIFEDIPINE10MGCAPSULE / ORALAB1993-07-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072781-001NIFEDIPINE10MGCAPSULE / ORALAB1993-07-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A072781-001NIFEDIPINE10MGCAPSULE / ORALAB1993-07-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072781-001NIFEDIPINE10MGCAPSULE / ORALAB1993-07-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072781-001NIFEDIPINE10MGCAPSULE / ORALAB1993-07-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A072781-001NIFEDIPINE10MGCAPSULE / ORALAB1993-07-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A072781-001NIFEDIPINE10MGCAPSULE / ORALAB1993-07-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A072781-001NIFEDIPINE10MGCAPSULE / ORALAB1993-07-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A072781-001NIFEDIPINE10MGCAPSULE / ORALAB1993-07-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A072781-001NIFEDIPINE10MGCAPSULE / ORALAB1993-07-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A072781-001NIFEDIPINE10MGCAPSULE / ORALAB1993-07-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A072781-001NIFEDIPINE10MGCAPSULE / ORALAB1993-07-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A072781-001NIFEDIPINE10MGCAPSULE / ORALAB1993-07-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A072781-001NIFEDIPINE10MGCAPSULE / ORALAB1993-07-3087673890dc5c…
2021-03-12 10:30 UTC2021-03A072781-001NIFEDIPINE10MGCAPSULE / ORALAB1993-07-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A072781-001NIFEDIPINE10MGCAPSULE / ORALAB1993-07-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11A072781-001NIFEDIPINE10MGCAPSULE / ORALAB1993-07-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12A072781-001NIFEDIPINE10MGCAPSULE / ORALAB1993-07-303f01610625f2…
2019-09-15 20:21 UTC2019-09A072781-001NIFEDIPINE10MGCAPSULE / ORALAB1993-07-30b00525d2431f…
2019-07-19 19:46 UTC2019-07A072781-001NIFEDIPINE10MGCAPSULE / ORALAB1993-07-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A072781-001NIFEDIPINE10MGCAPSULE / ORALAB1993-07-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A072781-001NIFEDIPINE10MGCAPSULE / ORALAB1993-07-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12A072781-001NIFEDIPINE10MGCAPSULE / ORALAB1993-07-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A072781-001NIFEDIPINE10MGCAPSULE / ORALAB1993-07-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A072781-001NIFEDIPINE10MGCAPSULE / ORALAB1993-07-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A072781-001NIFEDIPINE10MGCAPSULE / ORALAB1993-07-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A072781-001NIFEDIPINE10MGCAPSULE / ORALAB1993-07-303f0d92c62455…
2023-05-13 08:27 UTC2023-05A072781-001NIFEDIPINE10MGCAPSULE / ORALAB1993-07-30053a50430f4f…
2023-01-26 05:58 UTC2023-01A072781-001NIFEDIPINE10MGCAPSULE / ORALAB1993-07-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A072781-001NIFEDIPINE10MGCAPSULE / ORALAB1993-07-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A072781-001NIFEDIPINE10MGCAPSULE / ORALAB1993-07-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A072781-001NIFEDIPINE10MGCAPSULE / ORALAB1993-07-30e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A072781-001NIFEDIPINE10MGCAPSULE / ORALAB1993-07-30cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A072781-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072781-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A072781-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072781-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072781-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072781-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072781-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072781-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072781-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A072781-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072781-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072781-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A072781-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A072781-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A072781-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A072781-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A072781-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A072781-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A072781-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A072781-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A072781-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A072781-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A072781-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A072781-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A072781-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A072781-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A072781-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A072781-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A072781-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A072781-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A072781-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A072781-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A072781-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A072781-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A072781-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A072781-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A072781-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A072781-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A072781-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A072781-001AB1cb3db0bc1861…

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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43386-440-242020-01-31C16284748780-19d75b9d0-37ae-f424-e053-dadaa90a57ceNifedipine Capsules

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43386-440-24Nifedipine100 in 1 BOTTLECAPSULE1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43386-440-24EA - Each43386-440847decbe-4c21-4b4a-a529-39df8fc2110112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NIFEDIPINEACTIVE INGREDIENTI9ZF7L6G2LNIFEDIPINE CAPSULE [CARILION MATERIALS MANAGEMENT]2
NIFEDIPINEACTIVE INGREDIENTI9ZF7L6G2LNIFEDIPINE (NIFEDIPINE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]2
NIFEDIPINEACTIVE MOIETYI9ZF7L6G2LNIFEDIPINE (NIFEDIPINE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]2
NIFEDIPINEACTIVE MOIETYI9ZF7L6G2LNIFEDIPINE CAPSULE [CARILION MATERIALS MANAGEMENT]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDNIFEDIPINE CAPSULE [CARILION MATERIALS MANAGEMENT]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDNIFEDIPINE (NIFEDIPINE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675NIFEDIPINE (NIFEDIPINE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675NIFEDIPINE CAPSULE [CARILION MATERIALS MANAGEMENT]2
GELATININACTIVE INGREDIENT2G86QN327LNIFEDIPINE (NIFEDIPINE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LNIFEDIPINE CAPSULE [CARILION MATERIALS MANAGEMENT]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXNIFEDIPINE (NIFEDIPINE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXNIFEDIPINE CAPSULE [CARILION MATERIALS MANAGEMENT]2
MENTHOLINACTIVE INGREDIENTL7T10EIP3ANIFEDIPINE CAPSULE [CARILION MATERIALS MANAGEMENT]2
MENTHOLINACTIVE INGREDIENTL7T10EIP3ANIFEDIPINE (NIFEDIPINE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANIFEDIPINE (NIFEDIPINE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANIFEDIPINE CAPSULE [CARILION MATERIALS MANAGEMENT]2
POVIDONE K30INACTIVE INGREDIENTU725QWY32XNIFEDIPINE CAPSULE [CARILION MATERIALS MANAGEMENT]2
POVIDONE K30INACTIVE INGREDIENTU725QWY32XNIFEDIPINE (NIFEDIPINE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]2
SHELLACINACTIVE INGREDIENT46N107B71ONIFEDIPINE CAPSULE [CARILION MATERIALS MANAGEMENT]2
SHELLACINACTIVE INGREDIENT46N107B71ONIFEDIPINE (NIFEDIPINE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]2
SORBITANINACTIVE INGREDIENT6O92ICV9RUNIFEDIPINE (NIFEDIPINE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]2
SORBITANINACTIVE INGREDIENT6O92ICV9RUNIFEDIPINE CAPSULE [CARILION MATERIALS MANAGEMENT]2
SORBITOLINACTIVE INGREDIENT506T60A25RNIFEDIPINE CAPSULE [CARILION MATERIALS MANAGEMENT]2
SORBITOLINACTIVE INGREDIENT506T60A25RNIFEDIPINE (NIFEDIPINE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNIFEDIPINE CAPSULE [CARILION MATERIALS MANAGEMENT]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNIFEDIPINE (NIFEDIPINE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RNIFEDIPINE CAPSULE [CARILION MATERIALS MANAGEMENT]2
WATERINACTIVE INGREDIENT059QF0KO0RNIFEDIPINE (NIFEDIPINE) CAPSULE [PD-RX PHARMACEUTICALS, INC.]2
NIFEDIPINEACTIVE INGREDIENTI9ZF7L6G2LNIFEDIPINE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
NIFEDIPINEACTIVE INGREDIENTI9ZF7L6G2LNIFEDIPINE (NIFEDIPINE) CAPSULE [GAVIS PHARMACEUTICALS, LLC]1
NIFEDIPINEACTIVE MOIETYI9ZF7L6G2LNIFEDIPINE (NIFEDIPINE) CAPSULE [GAVIS PHARMACEUTICALS, LLC]1
NIFEDIPINEACTIVE MOIETYI9ZF7L6G2LNIFEDIPINE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDNIFEDIPINE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDNIFEDIPINE (NIFEDIPINE) CAPSULE [GAVIS PHARMACEUTICALS, LLC]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675NIFEDIPINE (NIFEDIPINE) CAPSULE [GAVIS PHARMACEUTICALS, LLC]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675NIFEDIPINE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LNIFEDIPINE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LNIFEDIPINE (NIFEDIPINE) CAPSULE [GAVIS PHARMACEUTICALS, LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXNIFEDIPINE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXNIFEDIPINE (NIFEDIPINE) CAPSULE [GAVIS PHARMACEUTICALS, LLC]1
ISOBUTYL ALCOHOLINACTIVE INGREDIENT56F9Z98TEMNIFEDIPINE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3ANIFEDIPINE (NIFEDIPINE) CAPSULE [GAVIS PHARMACEUTICALS, LLC]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3ANIFEDIPINE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ANIFEDIPINE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ANIFEDIPINE (NIFEDIPINE) CAPSULE [GAVIS PHARMACEUTICALS, LLC]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XNIFEDIPINE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XNIFEDIPINE (NIFEDIPINE) CAPSULE [GAVIS PHARMACEUTICALS, LLC]1
SHELLACINACTIVE INGREDIENT46N107B71ONIFEDIPINE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
SHELLACINACTIVE INGREDIENT46N107B71ONIFEDIPINE (NIFEDIPINE) CAPSULE [GAVIS PHARMACEUTICALS, LLC]1
SORBITANINACTIVE INGREDIENT6O92ICV9RUNIFEDIPINE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
SORBITANINACTIVE INGREDIENT6O92ICV9RUNIFEDIPINE (NIFEDIPINE) CAPSULE [GAVIS PHARMACEUTICALS, LLC]1
SORBITOLINACTIVE INGREDIENT506T60A25RNIFEDIPINE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RNIFEDIPINE (NIFEDIPINE) CAPSULE [GAVIS PHARMACEUTICALS, LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNIFEDIPINE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNIFEDIPINE (NIFEDIPINE) CAPSULE [GAVIS PHARMACEUTICALS, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RNIFEDIPINE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RNIFEDIPINE (NIFEDIPINE) CAPSULE [GAVIS PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43386-440NIFEDIPINE CAPSULE [LUPIN PHARMACEUTICALS INC]5Legacy NDC, 1 package rows20180928_0cc236dc-95fa-49cc-aeb8-6590de157585.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NifedipineNIFEDIPINENuCare Pharmaceuticals,Inc.9b0263a7-c492-40ea-e053-2a95a90a561e2024-08-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072781
application number: ANDA072781

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198032NIFEdipine 10 MG Oral CapsulePSN0cc236dc-95fa-49cc-aeb8-6590de1575855
198032nifedipine 10 MG Oral CapsuleSCD0cc236dc-95fa-49cc-aeb8-6590de1575855
198032NIFEdipine 10 MG Oral CapsulePSN4f43889f-3e6a-6a5c-e054-00144ff8d46c3
198032NIFEdipine 10 MG Oral CapsulePSN9b0263a7-c492-40ea-e053-2a95a90a561e3
198032nifedipine 10 MG Oral CapsuleSCD4f43889f-3e6a-6a5c-e054-00144ff8d46c3
198032nifedipine 10 MG Oral CapsuleSCD9b0263a7-c492-40ea-e053-2a95a90a561e3
198032NIFEdipine 10 MG Oral CapsulePSNce3366e2-ede3-4321-bd1c-8aacc869fe462
198032nifedipine 10 MG Oral CapsuleSCDce3366e2-ede3-4321-bd1c-8aacc869fe462

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
43386-440-2443386044024100 in 1 BOTTLEHistorical