Home NDC 44567-850 Nicardipine Hydrochloride in Sodium Chloride
Product NDC 44567-850
11-digit product format 445670850
Labeler code 44567
Product ID 44567-850_9ffe6b6f-b8bc-413f-9bec-7639e9d71d3d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nicardipine Hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler WG Critical Care, LLC
Application ANDA203978
Marketing category ANDA
Marketing start 2025-07-10
Substance NICARDIPINE HYDROCHLORIDE
Active strength .1 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A203978-001 NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE NICARDIPINE HYDROCHLORIDE 20MG/200ML (0.1MG/ML) INJECTABLE / INTRAVENOUS AP 2024-04-17 A203978-002 NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE NICARDIPINE HYDROCHLORIDE 40MG/200ML (0.2MG/ML) INJECTABLE / INTRAVENOUS AP 2024-04-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203978-001 NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE 20MG/200ML (0.1MG/ML) INJECTABLE / INTRAVENOUS AP 2024-04-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203978-002 NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE 40MG/200ML (0.2MG/ML) INJECTABLE / INTRAVENOUS AP 2024-04-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203978-001 NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE 20MG/200ML (0.1MG/ML) INJECTABLE / INTRAVENOUS AP 2024-04-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203978-002 NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE 40MG/200ML (0.2MG/ML) INJECTABLE / INTRAVENOUS AP 2024-04-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203978-001 NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE 20MG/200ML (0.1MG/ML) INJECTABLE / INTRAVENOUS AP 2024-04-17 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A203978-002 NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE 40MG/200ML (0.2MG/ML) INJECTABLE / INTRAVENOUS AP 2024-04-17 8072bd15b7f6…2026-08-01 22:54:32 2026-06 A203978-001 NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE 20MG/200ML (0.1MG/ML) INJECTABLE / INTRAVENOUS AP 2024-04-17 a50c72e98297…2026-08-01 22:54:32 2026-06 A203978-002 NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE 40MG/200ML (0.2MG/ML) INJECTABLE / INTRAVENOUS AP 2024-04-17 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 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Nicardipine Hydrochloride in Sodium Chloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NICARDIPINE HYDROCHLORIDE .1 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 858599 Internal RxNorm lookup 858603 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 44567-850-01 Nicardipine Hydrochloride in Sodium Chloride 200 mL in 1 BAG INJECTION, SOLUTION 200 1 44567-850-12 Nicardipine Hydrochloride in Sodium Chloride 12 in 1 CARTON INJECTION, SOLUTION 12 1
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 44567-850-01 44567085001 200 mL in 1 BAG 200 ml Historical 44567-850-12 44567085012 12 BAG in 1 CARTON (44567-850-12) / 200 mL in 1 BAG (44567-850-01) 12 bag 2025-07-10 No No Current