FDA.reportPublic FDA data

Application 090125

Type
ANDA
Sponsor
NAVINTA LLC

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 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…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 2 · 35 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NICARDIPINE HYDROCHLORIDENICARDIPINE HYDROCHLORIDEAmerisyn LLC575c5dab-e832-192a-e063-6294a90a34a12026-07-24Warnings, Adverse reactionsName fallback
brand name: NICARDIPINE HYDROCHLORIDE
generic name: NICARDIPINE HYDROCHLORIDE
Nicardipine HydrochlorideNICARDIPINE HYDROCHLORIDECaplin Steriles Limited9383f1dc-0310-4c87-a8f0-48c09a85d89b2026-06-25Warnings, Adverse reactionsName fallback
brand name: Nicardipine Hydrochloride
generic name: NICARDIPINE HYDROCHLORIDE
Nicardipine hydrochlorideNICARDIPINE HYDROCHLORIDELifestar Pharma LLCb0e2bed3-f928-43ab-a05c-275bedc9856f2026-04-24Warnings, Adverse reactionsName fallback
brand name: Nicardipine hydrochloride
generic name: NICARDIPINE HYDROCHLORIDE
Nicardipine HydrochlorideNICARDIPINE HYDROCHLORIDESomerset Therapeutics, LLCf8b49f59-7a54-425d-9eca-dfa4022a08d12026-04-20Warnings, Adverse reactionsName fallback
brand name: Nicardipine Hydrochloride
generic name: NICARDIPINE HYDROCHLORIDE
CARDENE IVNICARDIPINE HYDROCHLORIDEBaxter Healthcare Corporationa3e33add-0d09-423a-9109-42e5ba7148d52026-04-13Warnings, Adverse reactionsName fallback
generic name: NICARDIPINE HYDROCHLORIDE
Cardene IVNICARDIPINE HYDROCHLORIDEBaxter Healthcare Corporation5499cfac-9147-4d5d-a8cb-f8d64f1481af2026-04-13Warnings, Adverse reactionsName fallback
generic name: NICARDIPINE HYDROCHLORIDE
CARDENE IVNICARDIPINE HYDROCHLORIDEBaxter Healthcare Corporationf12cea0d-b7cd-41d8-b551-2c74cc7f5f4e2026-03-27Warnings, Adverse reactionsName fallback
generic name: NICARDIPINE HYDROCHLORIDE
NICARDIPINE HYDROCHLORIDENICARDIPINE HYDROCHLORIDEFresenius Kabi USA, LLCcdafe6cc-b03e-4e72-9d0a-6baa977149d62026-03-06Warnings, Adverse reactionsName fallback
brand name: NICARDIPINE HYDROCHLORIDE
generic name: NICARDIPINE HYDROCHLORIDE
Nicardipine HydrochlorideNICARDIPINE HYDROCHLORIDEGlenmark Pharmaceuticals Inc., USA3955d43d-a87f-4d2c-b90e-3ecf0d6aa1482026-01-29Warnings, Adverse reactionsName fallback
brand name: Nicardipine Hydrochloride
generic name: NICARDIPINE HYDROCHLORIDE
NICARDIPINE HYDROCHLORIDENICARDIPINE HYDROCHLORIDEAmici Pharma Incedda985c-004e-4487-b856-13cf2cdb900f2026-01-08Warnings, Adverse reactionsName fallback
brand name: NICARDIPINE HYDROCHLORIDE
generic name: NICARDIPINE HYDROCHLORIDE
CARDENE IVNICARDIPINE HYDROCHLORIDEBaxter Healthcare Corporation5749599d-ff2a-42e4-aa72-cd25013feee82025-12-29Warnings, Adverse reactionsName fallback
generic name: NICARDIPINE HYDROCHLORIDE
Nicardipine HydrochlorideNICARDIPINE HYDROCHLORIDESagent Pharmaceuticalsc576c9d5-853b-4e93-be6c-3579dfa5564c2025-12-29Warnings, Adverse reactionsName fallback
brand name: Nicardipine Hydrochloride
generic name: NICARDIPINE HYDROCHLORIDE
Nicardipine HydrochlorideNICARDIPINE HYDROCHLORIDEANI Pharmaceuticals, Inc.d1e275b8-c71a-4e8b-bca0-cfea048b53432025-12-22Warnings, Adverse reactionsName fallback
brand name: Nicardipine Hydrochloride
generic name: NICARDIPINE HYDROCHLORIDE
NICARDIPINE HYDROCHLORIDENICARDIPINE HYDROCHLORIDEChengdu Shuode Pharmaceutical Co., Ltd433dbca3-0a86-44c2-835d-1051c1c938782025-11-10Warnings, Adverse reactionsName fallback
brand name: NICARDIPINE HYDROCHLORIDE
generic name: NICARDIPINE HYDROCHLORIDE
nicardipine hydrochlorideNICARDIPINE HYDROCHLORIDEMeitheal Pharmaceuticals Inc.372a4381-7302-4df7-81bb-a9521907f8672025-08-28Warnings, Adverse reactionsName fallback
brand name: nicardipine hydrochloride
generic name: NICARDIPINE HYDROCHLORIDE
Nicardipine HydrochlorideNICARDIPINE HYDROCHLORIDEZydus Pharmaceuticals USA Inc.861247cc-3edf-4497-b230-2147489548b32025-07-08Warnings, Adverse reactionsName fallback
brand name: Nicardipine Hydrochloride
generic name: NICARDIPINE HYDROCHLORIDE
Nicardipine Hydrochloride in Sodium ChlorideNICARDIPINE HYDROCHLORIDEWG Critical Care, LLC9ffe6b6f-b8bc-413f-9bec-7639e9d71d3d2025-06-30Warnings, Adverse reactionsName fallback
generic name: NICARDIPINE HYDROCHLORIDE
NICARDIPINE HYDROCHLORIDENICARDIPINE HYDROCHLORIDEMicro Labs Limited8e8611e0-7d8c-4f30-b53a-76c6588b6ef72025-04-23Warnings, Adverse reactionsName fallback
brand name: NICARDIPINE HYDROCHLORIDE
generic name: NICARDIPINE HYDROCHLORIDE
Nicardipine HydrochlorideNICARDIPINE HYDROCHLORIDEQilu Pharmaceutical Co., Ltd.7433b5cd-9c3a-428a-bcaf-00f02cd526332025-04-23Warnings, Adverse reactionsName fallback
brand name: Nicardipine Hydrochloride
generic name: NICARDIPINE HYDROCHLORIDE
NICARDIPINE HYDROCHLORIDENICARDIPINE HYDROCHLORIDECipla USA Inc.570af1f8-6718-4b40-ae89-0f738d330ebd2025-04-08Warnings, Adverse reactionsName fallback
brand name: NICARDIPINE HYDROCHLORIDE
generic name: NICARDIPINE HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-3204Nicardipine HydrochlorideNicardipine HydrochlorideSandoz Inc.ANDACurrent
0781-9324Nicardipine HydrochlorideNicardipine HydrochlorideSandoz Inc.ANDACurrent
14593-124Nicardipine HydrochlorideNicardipine HydrochlorideEmcure Pharmaceuticals Ltd.ANDACurrent