Home NDC 71288-204 nicardipine hydrochloride
Product NDC 71288-204
11-digit product format 712880204
Labeler code 71288
Product ID 71288-204_cb0726e2-244f-4842-848d-7591dfbc96bb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name nicardipine hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Meitheal Pharmaceuticals Inc.
Application ANDA216819
Marketing category ANDA
Marketing start 2025-08-20
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 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216819-001 NICARDIPINE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION AP 2025-08-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216819-001 AP
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 A216819-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION AP 2025-08-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216819-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION AP 2025-08-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216819-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION AP 2025-08-20 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216819-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION AP 2025-08-20 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-18 06:07:40 2026-07 A216819-001 AP 1 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216819-001 AP 1 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216819-001 AP 1 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216819-001 AP 1 a50c72e98297…
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 71288-204-10 nicardipine hydrochloride 10 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 10 4 71288-204-11 nicardipine hydrochloride 10 in 1 CARTON INJECTION, SOLUTION 10 4
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 · 1 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 71288-204-10 71288020410 10 mL in 1 VIAL, SINGLE-DOSE 10 ml Historical 71288-204-11 71288020411 10 VIAL, SINGLE-DOSE in 1 CARTON (71288-204-11) / 10 mL in 1 VIAL, SINGLE-DOSE (71288-204-10) 2025-08-20 No No Current