FDA.reportPublic FDA data

Application 078405

Type
NDA
Sponsor
SUN PHARMA GLOBAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NICARDIPINE HYDROCHLORIDENICARDIPINE HYDROCHLORIDEINJECTABLE;INJECTION25MG/10ML (2.5MG/ML)NoNo

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

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
N078405-001NICARDIPINE 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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N078405-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-1784e616aacf4f…
2026-08-18 06:07:402026-07N078405-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N078405-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N078405-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08N078405-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N078405-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N078405-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N078405-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N078405-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N078405-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N078405-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N078405-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N078405-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N078405-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N078405-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05N078405-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N078405-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTIONAP2009-11-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N078405-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTIONAP2009-11-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N078405-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTIONAP2009-11-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N078405-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03N078405-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTIONAP2009-11-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N078405-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTIONAP2009-11-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N078405-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-1787673890dc5c…
2021-03-12 10:30 UTC2021-03N078405-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N078405-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11N078405-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12N078405-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-173f01610625f2…
2019-09-15 20:21 UTC2019-09N078405-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-17b00525d2431f…
2019-07-19 19:46 UTC2019-07N078405-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N078405-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N078405-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12N078405-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N078405-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N078405-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N078405-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTIONAP2009-11-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N078405-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTIONAP2009-11-173f0d92c62455…
2023-05-13 08:27 UTC2023-05N078405-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTIONAP2009-11-17053a50430f4f…
2023-01-26 05:58 UTC2023-01N078405-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTIONAP2009-11-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N078405-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTIONAP2009-11-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N078405-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTIONAP2009-11-17f41ea6bd6efb…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N078405-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N078405-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N078405-001AP14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N078405-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N078405-001AP1782e0a99824c…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N078405-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N078405-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05N078405-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01N078405-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N078405-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N078405-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N078405-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N078405-001AP1cb3db0bc1861…

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 2 of 2 · 34 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nicardipine HydrochlorideNICARDIPINE HYDROCHLORIDEArchis Pharma LLCd0070638-bea5-413a-8658-4c752c6104f52024-12-05Warnings, Adverse reactionsName fallback
brand name: Nicardipine Hydrochloride
generic name: NICARDIPINE HYDROCHLORIDE
Nicardipine HydrochlorideNICARDIPINE HYDROCHLORIDEBionpharma Inc.7bed5d8c-30c2-4598-acf3-2edba825a56d2024-11-04Warnings, Adverse reactionsName fallback
brand name: Nicardipine Hydrochloride
generic name: NICARDIPINE HYDROCHLORIDE
Nicardipine hydrochlorideNICARDIPINEAmneal Pharmaceuticals NY LLC79304b0f-53d3-4065-8c81-7031d11416942024-10-03Warnings, Adverse reactionsName fallback
brand name: Nicardipine hydrochloride
Nicardipine HydrochlorideNICARDIPINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.18fb1c2b-0c1e-436c-a5b6-d4840b5da2282024-08-24Warnings, Adverse reactionsName fallback
brand name: Nicardipine Hydrochloride
generic name: NICARDIPINE HYDROCHLORIDE
Nicardipine HydrochlorideNICARDIPINE HYDROCHLORIDEArmas Pharmaceuticals Inc.7226a518-164b-4755-9624-1cc75c9390632024-04-04Warnings, Adverse reactionsName fallback
brand name: Nicardipine Hydrochloride
generic name: NICARDIPINE HYDROCHLORIDE
Nicardipine HydrochlorideNICARDIPINE HYDROCHLORIDEEpic Pharma, LLCb8f147b8-955f-4733-9178-2cfa0beb60d62023-12-27Warnings, Adverse reactionsName fallback
brand name: Nicardipine Hydrochloride
generic name: NICARDIPINE HYDROCHLORIDE
NICARDIPINE HYDROCHLORIDENICARDIPINE HYDROCHLORIDEBurel Pharmaceuticals, LLCcb902af0-b5ad-4680-b2f2-007ef2196efe2023-09-07Warnings, Adverse reactionsName fallback
brand name: NICARDIPINE HYDROCHLORIDE
generic name: NICARDIPINE HYDROCHLORIDE
NICARDIPINE HYDROCHLORIDENICARDIPINE HYDROCHLORIDEEugia US LLC9f5d3050-9cdf-404f-ac0f-72399178959f2023-06-23Warnings, Adverse reactionsName fallback
brand name: NICARDIPINE HYDROCHLORIDE
generic name: NICARDIPINE HYDROCHLORIDE
NICARDIPINE HYDROCHLORIDENICARDIPINE HYDROCHLORIDEEugia US LLCdcd7d173-4d8e-4282-9edf-817711340e432021-10-11Warnings, Adverse reactionsName fallback
brand name: NICARDIPINE HYDROCHLORIDE
generic name: NICARDIPINE HYDROCHLORIDE
Nicardipine HydrochlorideNICARDIPINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.55bd6dcc-1f12-4378-8e9e-1ceed26818f52021-07-21Warnings, Adverse reactionsName fallback
brand name: Nicardipine Hydrochloride
generic name: NICARDIPINE HYDROCHLORIDE
Nicardipine HydrochlorideNICARDIPINE HYDROCHLORIDEAmerican Regent, Inc.76fcb7e0-9034-4fcd-be14-ce7e9ccaee2a2020-05-01Warnings, Adverse reactionsName fallback
brand name: Nicardipine Hydrochloride
generic name: NICARDIPINE HYDROCHLORIDE
Nicardipine HydrochlorideNICARDIPINE HYDROCHLORIDECivica, Inc.30fb3a4d-fa75-42fd-b4b6-2a21f202027f2020-05-01Warnings, Adverse reactionsName fallback
brand name: Nicardipine Hydrochloride
generic name: NICARDIPINE HYDROCHLORIDE
Nicardipine HydrochlorideNICARDIPINE HYDROCHLORIDEPuraCap Laboratories LLC dba Blu Pharmaceuticals065efabf-8c7d-4dd5-aef2-700c2eca399d2019-01-07Warnings, Adverse reactionsName fallback
brand name: Nicardipine Hydrochloride
generic name: NICARDIPINE HYDROCHLORIDE
Nicardipine HydrochlorideNICARDIPINE HYDROCHLORIDEWest-Ward Pharmaceuticals Corp0eb7d839-63d9-4b51-bf7b-4a8fde6339b52018-12-12Warnings, Adverse reactionsName fallback
brand name: Nicardipine Hydrochloride
generic name: NICARDIPINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
47335-882nicardipine hydrochloridenicardipine hydrochlorideSun Pharmaceutical Industries, Inc.NDACurrent