Nicardipine Hydrochloride

Product NDC
0781-9324
11-digit product format
007819324
Labeler code
0781
Product ID
0781-9324_31105e1d-2504-424a-affb-78877470b247
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nicardipine Hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Sandoz Inc.
Application
ANDA090125
Marketing category
ANDA
Marketing start
2010-09-27
Marketing end
0000-00-00
Substance
NICARDIPINE HYDROCHLORIDE
Active strength
3 mg/mL
Pharmacologic classes
Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0781-9324IInactivated by FDA2026-08-03
excluded packagepackage0781-93240781-9324-95IInactivated by FDA2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 34 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-03-10 12:48 UTC · source 2025-03-10excluded productproduct0781-9324IInactivated by FDAexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0781-93240781-9324-95IInactivated by FDAexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct0781-9324IInactivated by FDAexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0781-93240781-9324-95IInactivated by FDAexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproduct0781-9324IInactivated by FDAexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0781-93240781-9324-95IInactivated by FDAexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0781-9324IInactivated by FDAexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0781-93240781-9324-95IInactivated by FDAexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproduct0781-9324IInactivated by FDAexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0781-93240781-9324-95IInactivated by FDAexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct0781-9324IInactivated by FDAexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0781-93240781-9324-95IInactivated by FDAexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct0781-9324IInactivated by FDAexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0781-93240781-9324-95IInactivated by FDAexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct0781-9324IInactivated by FDAexcluded / ndc_excluded.zip8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage0781-93240781-9324-95IInactivated by FDAexcluded / ndc_excluded.zip8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct0781-9324IInactivated by FDAexcluded / ndc_excluded.zip834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage0781-93240781-9324-95IInactivated by FDAexcluded / ndc_excluded.zip834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct0781-9324IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage0781-93240781-9324-95IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproduct0781-9324IInactivated by FDAexcluded / ndc_excluded.zipfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage0781-93240781-9324-95IInactivated by FDAexcluded / ndc_excluded.zipfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct0781-9324IInactivated by FDAexcluded / ndc_excluded.zip86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage0781-93240781-9324-95IInactivated by FDAexcluded / ndc_excluded.zip86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproduct0781-9324IInactivated by FDAexcluded / ndc_excluded.zipbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage0781-93240781-9324-95IInactivated by FDAexcluded / ndc_excluded.zipbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct0781-9324IInactivated by FDAexcluded / ndc_excluded.zip8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage0781-93240781-9324-95IInactivated by FDAexcluded / ndc_excluded.zip8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproduct0781-9324IInactivated by FDAexcluded / ndc_excluded.zipe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage0781-93240781-9324-95IInactivated by FDAexcluded / ndc_excluded.zipe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct0781-9324IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage0781-93240781-9324-95IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct0781-9324IInactivated by FDAexcluded / ndc_excluded.zip110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage0781-93240781-9324-95IInactivated by FDAexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

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
A090125-001NICARDIPINE HYDROCHLORIDENICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-17

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 UTC2026-02A090125-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090125-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A090125-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090125-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090125-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090125-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090125-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090125-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090125-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090125-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090125-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090125-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090125-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090125-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090125-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090125-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090125-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090125-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090125-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090125-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090125-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-1787673890dc5c…
2021-03-12 10:30 UTC2021-03A090125-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090125-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090125-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090125-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-173f01610625f2…
2019-09-15 20:21 UTC2019-09A090125-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-17b00525d2431f…
2019-07-19 19:46 UTC2019-07A090125-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090125-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090125-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090125-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090125-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090125-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090125-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090125-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-173f0d92c62455…
2023-05-13 08:27 UTC2023-05A090125-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-17053a50430f4f…
2023-01-26 05:58 UTC2023-01A090125-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090125-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090125-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-17f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090125-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-17e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090125-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-17cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
31746078-c5c3-4387-a2ed-bd3c8b244c53Product name220250325
037c6bd8-1c81-7b8c-8280-c83d993a1f03Product name220250203
c9eb0343-053f-7f78-730f-1be02ab91c6cProduct name520250130

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0781-9324-952019-10-29C16284748780-1960f7f55-c29f-8e05-e053-dbdaa90a074aRx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0781-9324-70Nicardipine Hydrochloride10 mL in 1 VIAL, GLASSINJECTION102
0781-9324-70Nicardipine Hydrochloride1 in 1 CARTONINJECTION12
0781-9324-95Nicardipine Hydrochloride10 in 1 CARTONINJECTION102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-9324-70ML - Milliliter0781-9324391a5e0a-b881-4676-bb3c-96ccfcc5b60212012-07-24
0781-9324-95ML - Milliliter0781-9324a34a87b2-c020-4bf0-9fb9-3beb73fa690612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NICARDIPINE HYDROCHLORIDEACTIVE INGREDIENTK5BC5011K3NICARDIPINE HYDROCHLORIDE INJECTION [SANDOZ INC. ]2
NICARDIPINEACTIVE MOIETYCZ5312222SNICARDIPINE HYDROCHLORIDE INJECTION [SANDOZ INC. ]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPNICARDIPINE HYDROCHLORIDE INJECTION [SANDOZ INC. ]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32INICARDIPINE HYDROCHLORIDE INJECTION [SANDOZ INC. ]2
SORBITOLINACTIVE INGREDIENT506T60A25RNICARDIPINE HYDROCHLORIDE INJECTION [SANDOZ INC. ]2
WATERINACTIVE INGREDIENT059QF0KO0RNICARDIPINE HYDROCHLORIDE INJECTION [SANDOZ INC. ]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-9324NICARDIPINE HYDROCHLORIDE INJECTION [SANDOZ INC. ]2Legacy NDC, 3 package rows20110526_d2f0b90f-9495-48c5-b21f-86e487a04854.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858607niCARdipine HCl 25 MG in 10 ML InjectionPSNd2f0b90f-9495-48c5-b21f-86e487a048542
85860710 ML nicardipine hydrochloride 2.5 MG/ML InjectionSCDd2f0b90f-9495-48c5-b21f-86e487a048542
858607nicardipine hydrochloride 25 MG per 10 ML InjectionSYd2f0b90f-9495-48c5-b21f-86e487a048542

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
0781-9324-700078193247010 mL in 1 VIAL, GLASS10 mlHistorical
0781-9324-950078193249510 in 1 CARTONHistorical