FDA.reportPublic FDA data

Nicardipine hydrochloride

Product NDC
70756-686
11-digit product format
707560686
Labeler code
70756
Product ID
70756-686_81fbc156-3cdc-4088-84fd-2d2bf30ebc66
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nicardipine hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Lifestar Pharma LLC
Application
ANDA090671
Marketing category
ANDA
Marketing start
2026-02-24
Substance
NICARDIPINE HYDROCHLORIDE
Active strength
2.5 mg/mL
Pharmacologic classes
Calcium Channel Antagonists [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090671-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTION2009-11-17cb3db0bc1861…
2026-08-01 22:54:322026-06A090671-001NICARDIPINE HYDROCHLORIDE25MG/10ML (2.5MG/ML)INJECTABLE / INJECTIONAP2009-11-17a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A090671-001AP1a50c72e98297…

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 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
ndc (product): 70756-686

Additional Listing Data#

Finished product
Yes
Brand name base
Nicardipine hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICARDIPINE HYDROCHLORIDE2.5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
K5BC5011K3Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
858607Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b0e2bed3-f928-43ab-a05c-275bedc9856fAvailable on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70756-686-10Nicardipine hydrochloride10 in 1 CARTONINJECTION103
70756-686-86Nicardipine hydrochloride10 mL in 1 VIALINJECTION103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70756-686-10ML - Milliliter70756-6866eaacc91-2685-4df4-a11e-87f7726a961612026-03-17
70756-686-86ML - Milliliter70756-68664e5ab7e-aa78-432d-9d3e-8f9c6920f56312026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858607niCARdipine HCl 25 MG in 10 ML InjectionPSNb0e2bed3-f928-43ab-a05c-275bedc9856f3
85860710 ML nicardipine hydrochloride 2.5 MG/ML InjectionSCDb0e2bed3-f928-43ab-a05c-275bedc9856f3
858607nicardipine hydrochloride 25 MG per 10 ML InjectionSYb0e2bed3-f928-43ab-a05c-275bedc9856f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70756-686-107075606861010 VIAL in 1 CARTON (70756-686-10) / 10 mL in 1 VIAL (70756-686-86) 10 vial2026-02-24NoNoCurrent
70756-686-867075606868610 mL in 1 VIAL10 mlHistorical