Home NDC 72819-149 Nicardipine Hydrochloride
Product NDC 72819-149
11-digit product format 728190149
Labeler code 72819
Product ID 72819-149_28899230-4ee7-c689-e063-6294a90a1b6c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name nicardipine hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Archis Pharma LLC
Application ANDA090664
Marketing category ANDA
Marketing start 2024-12-07
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 A090664-001 NICARDIPINE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION AP 2009-11-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090664-001 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.
Product history page 1 of 2 · 42 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 2026-08-18 06:07:40 2026-07 A090664-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION AP 2009-11-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090664-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION AP 2009-11-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090664-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION AP 2009-11-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090664-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION AP 2009-11-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090664-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION AP 2009-11-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090664-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION AP 2009-11-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090664-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION AP 2009-11-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090664-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION AP 2009-11-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090664-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION AP 2009-11-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090664-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION AP 2009-11-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090664-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION AP 2009-11-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090664-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION AP 2009-11-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090664-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION AP 2009-11-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090664-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION AP 2009-11-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090664-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION AP 2009-11-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090664-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION 2009-11-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090664-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION 2009-11-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090664-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION 2009-11-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090664-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION 2009-11-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090664-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION 2009-11-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090664-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION 2009-11-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090664-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION 2009-11-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090664-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION 2009-11-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090664-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION 2009-11-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090664-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION 2009-11-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090664-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION 2009-11-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090664-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION 2009-11-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090664-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION 2009-11-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090664-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION AP 2009-11-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090664-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION 2009-11-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090664-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION 2009-11-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090664-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION 2009-11-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090664-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION 2009-11-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090664-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION 2009-11-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090664-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION 2009-11-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090664-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION 2009-11-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090664-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION 2009-11-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090664-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION 2009-11-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090664-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION 2009-11-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090664-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION 2009-11-17 e64feba35796…
Observed Orange Book normalized TE history# 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 72819-149-06 Nicardipine Hydrochloride 10 mL in 1 VIAL INJECTION, SOLUTION 10 2 72819-149-07 Nicardipine Hydrochloride 10 in 1 CARTON INJECTION, SOLUTION 10 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72819-149 NICARDIPINE HYDROCHLORIDE INJECTION, SOLUTION [ARCHIS PHARMA LLC] 2 Current NDC, 2 package rows 20241208_d0070638-bea5-413a-8658-4c752c6104f5.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 · 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 72819-149-06 72819014906 10 mL in 1 VIAL 10 ml Historical 72819-149-07 72819014907 10 VIAL in 1 CARTON (72819-149-07) / 10 mL in 1 VIAL (72819-149-06) 10 vial 2024-12-07 No No Current