Home NDC 0143-9633 Nicardipine Hydrochloride
Product NDC 0143-9633
11-digit product format 001439633
Labeler code 0143
Product ID 0143-9633_299a0b28-ebf0-4753-983d-b9a16158d83c
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 2016-04-07
Substance NICARDIPINE HYDROCHLORIDE
Active strength .2 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 1 .
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.
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 2026-08-01 22:54:32 2026-06 N022276-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION AP RLD, RS 2008-07-24 a50c72e98297…2026-08-01 22:54:32 2026-06 N022276-002 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 20MG/200ML (0.1MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2016-04-07 a50c72e98297…2026-08-01 22:54:32 2026-06 N022276-003 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 40MG/200ML (0.2MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2016-04-07 a50c72e98297…
Observed Orange Book normalized TE history# 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 · 4 matching rows.
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 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 858599 Internal RxNorm lookup 858603 Internal RxNorm lookup 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 0143-9633-01 Nicardipine Hydrochloride 200 mL in 1 BAG INJECTION 200 13 0143-9633-10 Nicardipine Hydrochloride 10 in 1 CARTON INJECTION 10 13
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0143-9633 NICARDIPINE HYDROCHLORIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.] 13 Current NDC, Legacy NDC, 2 package rows 20250327_18fb1c2b-0c1e-436c-a5b6-d4840b5da228.zip
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 0143-9633-01 00143963301 200 mL in 1 BAG 200 ml Historical 0143-9633-10 00143963310 10 BAG in 1 CARTON (0143-9633-10) / 200 mL in 1 BAG (0143-9633-01) 10 bag 2016-04-07 0000-00-00 No No Current