Home NDC 0641-6231 HydrALAZINE hydrochloride
Product NDC 0641-6231
11-digit product format 006416231
Labeler code 0641
Product ID 0641-6231_e0fe7653-bdb1-42fc-8277-fc07794f85d5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name HydrALAZINE hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA213667
Marketing category ANDA
Marketing start 2020-12-18
Substance HYDRALAZINE HYDROCHLORIDE
Active strength 20 mg/mL
Pharmacologic classes Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
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 A213667-001 HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2020-12-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A213667-001 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 A213667-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2020-12-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213667-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2020-12-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213667-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2020-12-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213667-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2020-12-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213667-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2020-12-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213667-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2020-12-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213667-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2020-12-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213667-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2020-12-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213667-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2020-12-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213667-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2020-12-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213667-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2020-12-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213667-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2020-12-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213667-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2020-12-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213667-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2020-12-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213667-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2020-12-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213667-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2020-12-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213667-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2020-12-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A213667-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2020-12-18 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A213667-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2020-12-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A213667-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2020-12-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A213667-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2020-12-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A213667-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2020-12-18 5aa47cf7b7d7…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213667-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2020-12-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213667-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2020-12-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213667-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2020-12-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213667-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2020-12-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213667-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2020-12-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213667-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2020-12-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A213667-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2020-12-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A213667-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2020-12-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A213667-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2020-12-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A213667-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2020-12-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A213667-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2020-12-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A213667-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2020-12-18 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A213667-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2020-12-18 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213667-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2020-12-18 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base HydrALAZINE hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDRALAZINE HYDROCHLORIDE 20 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination FD171B778Y Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 966571 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 0641-6231-01 HydrALAZINE hydrochloride 20 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 20 2 0641-6231-25 HydrALAZINE hydrochloride 25 in 1 CARTON INJECTION, SOLUTION 25 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0641-6231 HYDRALAZINE HYDROCHLORIDE INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.] 2 Current NDC, Legacy NDC, 2 package rows 20240411_3f5f1204-d289-40e9-be84-a29352f64bfb.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0641-6231-01 00641623101 20 mL in 1 VIAL, SINGLE-DOSE 20 ml Historical 0641-6231-25 00641623125 25 VIAL, SINGLE-DOSE in 1 CARTON (0641-6231-25) / 20 mL in 1 VIAL, SINGLE-DOSE (0641-6231-01) 2020-12-18 0000-00-00 No No Current