Home NDC 65145-198 Nicardipine Hydrochloride
Product NDC 65145-198
11-digit product format 651450198
Labeler code 65145
Product ID 65145-198_9383f1dc-0310-4c87-a8f0-48c09a85d89b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nicardipine Hydrochloride
Dosage form INJECTION
Route INTRAVENOUS
Labeler Caplin Steriles Limited
Application ANDA220243
Marketing category ANDA
Marketing start 2025-11-04
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 42 .
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 A220243-001 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE NICARDIPINE HYDROCHLORIDE 20MG/200ML (0.1MG/ML) INJECTABLE / INTRAVENOUS AP 2025-10-22 A220243-002 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE NICARDIPINE HYDROCHLORIDE 40MG/200ML (0.2MG/ML) INJECTABLE / INTRAVENOUS AP 2025-10-22
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 2026-08-18 06:07:40 2026-07 A220243-001 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 20MG/200ML (0.1MG/ML) INJECTABLE / INTRAVENOUS AP 2025-10-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A220243-002 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 40MG/200ML (0.2MG/ML) INJECTABLE / INTRAVENOUS AP 2025-10-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A220243-001 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 20MG/200ML (0.1MG/ML) INJECTABLE / INTRAVENOUS AP 2025-10-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A220243-002 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 40MG/200ML (0.2MG/ML) INJECTABLE / INTRAVENOUS AP 2025-10-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A220243-001 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 20MG/200ML (0.1MG/ML) INJECTABLE / INTRAVENOUS AP 2025-10-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A220243-002 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 40MG/200ML (0.2MG/ML) INJECTABLE / INTRAVENOUS AP 2025-10-22 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220243-001 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 20MG/200ML (0.1MG/ML) INJECTABLE / INTRAVENOUS AP 2025-10-22 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220243-002 NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 40MG/200ML (0.2MG/ML) INJECTABLE / INTRAVENOUS AP 2025-10-22 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Nicardipine Hydrochloride
Listing expiration 2027-12-31 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 · 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 65145-198-01 Nicardipine Hydrochloride 200 mL in 1 BAG INJECTION 200 1 65145-198-01 Nicardipine Hydrochloride 1 in 1 POUCH INJECTION 1 1
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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 65145-198-01 65145019801 1 BAG in 1 POUCH (65145-198-01) / 200 mL in 1 BAG 1 bag 2025-11-04 No No Historical 65145-198-10 65145019810 10 POUCH in 1 CASE (65145-198-10) / 1 BAG in 1 POUCH (65145-198-01) / 200 mL in 1 BAG 10 pouch 2026-06-25 0 Current