Home NDC 64679-631 Nicardipine Hydrochloride
Product NDC 64679-631
11-digit product format 646790631
Labeler code 64679
Product ID 64679-631_3f6bbe56-5d77-499b-ba75-9129b87a1592
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nicardipine Hydrochloride
Dosage form INJECTION
Route INTRAVENOUS
Labeler Wockhardt USA LLC.
Application ANDA090671
Marketing category ANDA
Marketing start 2009-11-17
Marketing end 0000-00-00
Substance NICARDIPINE HYDROCHLORIDE
Active strength 3 mg/mL
Pharmacologic classes Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product 64679-631 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 64679-631 64679-631-02 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A090671-001 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 A090671-001 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 · 41 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 2026-02-19 14:30 UTC 2026-02 A090671-001 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 A090671-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION AP 2009-11-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090671-001 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 A090671-001 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 A090671-001 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 A090671-001 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 A090671-001 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 A090671-001 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 A090671-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION AP 2009-11-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090671-001 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 A090671-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION 2009-11-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090671-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION 2009-11-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090671-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION 2009-11-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090671-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION 2009-11-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090671-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION 2009-11-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090671-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION 2009-11-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090671-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION 2009-11-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090671-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION 2009-11-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090671-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION 2009-11-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090671-001 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 A090671-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION 2009-11-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090671-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION 2009-11-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090671-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION 2009-11-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090671-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION 2009-11-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090671-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION 2009-11-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090671-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION 2009-11-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090671-001 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 A090671-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION 2009-11-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090671-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION 2009-11-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090671-001 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 A090671-001 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 A090671-001 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 A090671-001 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 A090671-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION 2009-11-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090671-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION 2009-11-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090671-001 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 A090671-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION 2009-11-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090671-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION 2009-11-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090671-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION 2009-11-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A090671-001 NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE / INJECTION 2009-11-17 cb3db0bc1861…
Observed Orange Book normalized TE history# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 64679-631-01 2023-03-13 These highlights do not include all the information needed to use Nicardipine hydrochloride injection, USP safely and effectively. See full prescribing information for Nicardipine hydrochloride injection. Nicardipine hydrochloride injection, USP, for intravenous use Initial U.S. Approval: 1988 64679-631-02 2023-03-13 These highlights do not include all the information needed to use Nicardipine hydrochloride injection, USP safely and effectively. See full prescribing information for Nicardipine hydrochloride injection. Nicardipine hydrochloride injection, USP, for intravenous use Initial U.S. Approval: 1988 64679-631-01 2023-01-30 These highlights do not include all the information needed to use Nicardipine hydrochloride injection, USP safely and effectively. See full prescribing information for Nicardipine hydrochloride injection. Nicardipine hydrochloride injection, USP, for intravenous use Initial U.S. Approval: 1988 64679-631-02 2023-01-30 These highlights do not include all the information needed to use Nicardipine hydrochloride injection, USP safely and effectively. See full prescribing information for Nicardipine hydrochloride injection. Nicardipine hydrochloride injection, USP, for intravenous use Initial U.S. Approval: 1988
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64679-631 NICARDIPINE HYDROCHLORIDE INJECTION [WOCKHARDT USA LLC.] 7 Legacy NDC 20240907_e61159ba-ff6b-4696-a642-4f64c79c4708.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 64679-631-01 64679063101 1 VIAL, SINGLE-DOSE in 1 CARTON (64679-631-01) > 10 mL in 1 VIAL, SINGLE-DOSE (64679-631-03) 2009-11-17 0000-00-00 No No Current 64679-631-02 64679063102 10 VIAL, SINGLE-DOSE in 1 CARTON (64679-631-02) > 10 mL in 1 VIAL, SINGLE-DOSE (64679-631-03) 2009-11-17 0000-00-00 No No Current