Home NDC 51662-1648 HYDRALAZINE HYDROCHLORIDE
Product NDC 51662-1648
11-digit product format 516621648
Labeler code 51662
Product ID 51662-1648_15b1adc3-9cb5-cf06-e063-6294a90a1da7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name HYDRALAZINE HYDROCHLORIDE
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler HF Acquisition Co LLC, DBA HealthFirst
Application ANDA040136
Marketing category ANDA
Marketing start 1997-06-30
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 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 A040136-001 HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 1997-06-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040136-001 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 A040136-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 1997-06-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040136-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 1997-06-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040136-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 1997-06-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040136-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 1997-06-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040136-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 1997-06-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040136-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 1997-06-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040136-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 1997-06-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040136-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 1997-06-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040136-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 1997-06-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040136-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 1997-06-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040136-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 1997-06-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040136-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 1997-06-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040136-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 1997-06-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040136-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 1997-06-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040136-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 1997-06-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040136-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 1997-06-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040136-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 1997-06-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040136-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION 1997-06-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040136-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 1997-06-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040136-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 1997-06-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040136-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 1997-06-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040136-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 1997-06-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040136-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 1997-06-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040136-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION 1997-06-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040136-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION 1997-06-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040136-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION 1997-06-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040136-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION 1997-06-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040136-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 1997-06-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040136-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 1997-06-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040136-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 1997-06-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040136-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 1997-06-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040136-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 1997-06-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040136-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 1997-06-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040136-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 1997-06-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040136-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 1997-06-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040136-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 1997-06-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040136-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 1997-06-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040136-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 1997-06-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040136-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 1997-06-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A040136-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 1997-06-30 cb3db0bc1861…
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 51662-1648-2 HYDRALAZINE HYDROCHLORIDE 1 in 1 POUCH INJECTION, SOLUTION 1 2 51662-1648-2 HYDRALAZINE HYDROCHLORIDE 1 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 1 2 51662-1648-3 HYDRALAZINE HYDROCHLORIDE 25 in 1 CASE INJECTION, SOLUTION 25 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51662-1648 HYDRALAZINE HYDROCHLORIDE INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] 2 Current NDC, 3 package rows 20240410_15b0f03b-b5a2-c49d-e063-6394a90a5b15.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 · 3 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 51662-1648-2 51662164802 1 in 1 POUCH Historical 51662-1648-3 51662164803 25 POUCH in 1 CASE (51662-1648-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1648-2) / 1 mL in 1 VIAL, SINGLE-DOSE 25 pouch 1997-06-30 No No Current