Home NDC 0143-9542-10 Nicardipine Hydrochloride
Product NDC 0143-9542
Requested package NDC 0143-9542-10
11-digit product format 001439542
Labeler code 0143
Product ID 0143-9542_b87038d9-8a91-428b-8d7f-6eef3a836742
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nicardipine Hydrochloride
Dosage form INJECTION
Route INTRAVENOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application NDA022276
Marketing category NDA
Marketing start 2012-03-02
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 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022276-001 NICARDIPINE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION AP RLD, RS 2008-07-24 N022276-002 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE NICARDIPINE HYDROCHLORIDE 20MG/200ML (0.1MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2016-04-07 N022276-003 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE NICARDIPINE HYDROCHLORIDE 40MG/200ML (0.2MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2016-04-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 4 · 129 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N022276-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION AP RLD, RS 2008-07-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022276-002 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 20MG/200ML (0.1MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2016-04-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022276-003 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 40MG/200ML (0.2MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2016-04-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022276-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION AP RLD, RS 2008-07-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022276-002 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 20MG/200ML (0.1MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2016-04-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022276-003 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 40MG/200ML (0.2MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2016-04-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022276-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION AP RLD, RS 2008-07-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022276-002 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 20MG/200ML (0.1MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2016-04-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022276-003 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 40MG/200ML (0.2MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2016-04-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022276-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION AP RLD, RS 2008-07-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022276-002 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 20MG/200ML (0.1MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2016-04-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022276-003 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 40MG/200ML (0.2MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2016-04-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022276-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION AP RLD, RS 2008-07-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022276-002 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 20MG/200ML (0.1MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2016-04-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022276-003 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 40MG/200ML (0.2MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2016-04-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022276-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION AP RLD, RS 2008-07-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022276-002 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 20MG/200ML (0.1MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2016-04-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022276-003 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 40MG/200ML (0.2MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2016-04-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022276-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION AP RLD, RS 2008-07-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022276-002 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 20MG/200ML (0.1MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2016-04-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022276-003 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 40MG/200ML (0.2MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2016-04-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022276-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION AP RLD, RS 2008-07-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022276-002 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 20MG/200ML (0.1MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2016-04-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022276-003 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 40MG/200ML (0.2MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2016-04-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022276-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION AP RLD, RS 2008-07-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022276-002 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 20MG/200ML (0.1MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2016-04-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022276-003 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 40MG/200ML (0.2MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2016-04-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022276-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION AP RLD, RS 2008-07-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022276-002 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 20MG/200ML (0.1MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2016-04-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022276-003 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 40MG/200ML (0.2MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2016-04-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022276-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION AP RLD, RS 2008-07-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022276-002 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 20MG/200ML (0.1MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2016-04-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022276-003 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 40MG/200ML (0.2MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2016-04-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022276-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION AP RLD, RS 2008-07-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022276-002 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 20MG/200ML (0.1MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2016-04-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022276-003 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 40MG/200ML (0.2MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2016-04-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022276-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION AP RLD, RS 2008-07-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022276-002 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 20MG/200ML (0.1MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2016-04-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022276-003 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 40MG/200ML (0.2MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2016-04-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022276-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION AP RLD, RS 2008-07-24 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 47 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Nicardipine Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NICARDIPINE HYDROCHLORIDE 2.5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination K5BC5011K3 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 858607 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0143-9542-01 Nicardipine Hydrochloride 10 mL in 1 VIAL INJECTION 10 6 0143-9542-10 Nicardipine Hydrochloride 10 in 1 CARTON INJECTION 10 6
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0143-9542 NICARDIPINE HYDROCHLORIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.] 6 Current NDC, Legacy NDC, 2 package rows 20220427_55bd6dcc-1f12-4378-8e9e-1ceed26818f5.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 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0143-9542-10 00143954210 10 VIAL in 1 CARTON (0143-9542-10) / 10 mL in 1 VIAL (0143-9542-01) 10 vial 2012-03-02 0000-00-00 No No Current