Nicardipine Hydrochloride

Product NDC
55648-631
11-digit product format
556480631
Labeler code
55648
Product ID
55648-631_1aa072e3-8f11-4e34-8d13-bc0021f33713
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nicardipine Hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Wockhardt Limited
Application
ANDA090671
Marketing category
ANDA
Marketing start
2009-11-09
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
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 productproduct55648-631IInactivated by FDA2026-08-17
excluded packagepackage55648-63155648-631-02IInactivated by FDA2026-08-17

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 packagepackage55648-631-02d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55648-631-02f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55648-631-022ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55648-631-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55648-631-02cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55648-631-02cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55648-631-02302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55648-631-02ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55648-631-020efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55648-631-02ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55648-631-02367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55648-631-02557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage55648-631-028af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage55648-631-02834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage55648-631-021332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage55648-631-02fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage55648-631-0286f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage55648-631-02bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage55648-631-028dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage55648-631-02e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage55648-631-029bebd1f3094a…5416666fcb17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A090671-001NICARDIPINE HYDROCHLORIDENICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTIONAP2009-11-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090671-001AP

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A090671-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTIONAP2009-11-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090671-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTIONAP2009-11-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090671-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTIONAP2009-11-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A090671-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTIONAP2009-11-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090671-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTIONAP2009-11-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090671-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTIONAP2009-11-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090671-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTIONAP2009-11-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090671-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTIONAP2009-11-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090671-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTIONAP2009-11-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090671-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTIONAP2009-11-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090671-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTIONAP2009-11-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090671-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090671-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090671-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090671-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090671-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090671-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090671-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090671-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090671-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090671-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090671-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-1787673890dc5c…
2021-03-12 10:30 UTC2021-03A090671-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090671-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090671-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090671-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-173f01610625f2…
2019-09-15 20:21 UTC2019-09A090671-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-17b00525d2431f…
2019-07-19 19:46 UTC2019-07A090671-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090671-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090671-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090671-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090671-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090671-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090671-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090671-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-173f0d92c62455…
2023-05-13 08:27 UTC2023-05A090671-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-17053a50430f4f…
2023-01-26 05:58 UTC2023-01A090671-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090671-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090671-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-17f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090671-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-17e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A090671-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090671-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090671-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090671-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090671-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090671-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090671-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090671-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090671-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090671-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090671-001AP1d06236e962d9…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A090671-001AP1a50c72e98297…

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
55648-631-022020-01-31C16284748780-19d75b9d1-1716-f424-e053-dadaa90a57ceNicardipine Hydrochloride Injection Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55648-631-01Nicardipine Hydrochloride1 in 1 CARTONINJECTION13
55648-631-01Nicardipine Hydrochloride10 mL in 1 VIAL, SINGLE-DOSEINJECTION103
55648-631-02Nicardipine Hydrochloride10 in 1 CARTONINJECTION103

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NICARDIPINE HYDROCHLORIDEACTIVE INGREDIENTK5BC5011K3NICARDIPINE HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]3
NICARDIPINEACTIVE MOIETYCZ5312222SNICARDIPINE HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]3
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPNICARDIPINE HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32INICARDIPINE HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]3
SORBITOLINACTIVE INGREDIENT506T60A25RNICARDIPINE HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]3
WATERINACTIVE INGREDIENT059QF0KO0RNICARDIPINE HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55648-631NICARDIPINE HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]3Legacy NDC, 3 package rows20121012_a6512740-17e0-4f22-a233-4ac084277879.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
Nicardipine hydrochlorideNICARDIPINE HYDROCHLORIDELifestar Pharma LLCb0e2bed3-f928-43ab-a05c-275bedc9856f2026-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090671
application number: ANDA090671

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858607niCARdipine HCl 25 MG in 10 ML InjectionPSNa6512740-17e0-4f22-a233-4ac0842778793
85860710 ML nicardipine hydrochloride 2.5 MG/ML InjectionSCDa6512740-17e0-4f22-a233-4ac0842778793
858607nicardipine hydrochloride 25 MG per 10 ML InjectionSYa6512740-17e0-4f22-a233-4ac0842778793

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
55648-631-01556480631011 in 1 CARTONHistorical
55648-631-025564806310210 in 1 CARTONHistorical