Home NDC 70710-1988 Hydralazine Hydrochloride
Product NDC 70710-1988
11-digit product format 707101988
Labeler code 70710
Product ID 70710-1988_080a71a3-1d50-42bf-b329-bf64a84893d6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydralazine Hydrochloride
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Zydus Pharmaceuticals USA Inc.
Application ANDA202938
Marketing category ANDA
Marketing start 2025-04-28
Substance HYDRALAZINE HYDROCHLORIDE
Active strength 20 mg/mL
Pharmacologic classes Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A202938-001 HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2013-03-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A202938-001 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 · 43 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 2026-09-14 22:38:34 2026-08 A202938-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2013-03-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 A202938-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2013-03-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202938-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2013-03-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202938-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2013-03-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202938-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2013-03-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202938-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2013-03-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202938-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2013-03-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202938-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2013-03-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202938-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2013-03-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202938-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2013-03-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202938-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2013-03-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202938-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2013-03-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202938-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2013-03-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202938-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2013-03-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202938-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2013-03-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202938-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2013-03-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202938-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2013-03-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202938-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2013-03-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202938-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2013-03-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202938-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2013-03-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202938-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2013-03-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202938-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2013-03-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A202938-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2013-03-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A202938-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2013-03-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A202938-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2013-03-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A202938-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2013-03-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A202938-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2013-03-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A202938-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2013-03-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A202938-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2013-03-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202938-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2013-03-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A202938-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2013-03-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A202938-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2013-03-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202938-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2013-03-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202938-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2013-03-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A202938-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2013-03-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A202938-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2013-03-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A202938-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2013-03-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A202938-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2013-03-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A202938-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2013-03-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A202938-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2013-03-28 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Hydralazine Hydrochloride
Listing expiration 2027-12-31 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 70710-1988-1 Hydralazine Hydrochloride 1 mL in 1 VIAL INJECTION 1 2 70710-1988-7 Hydralazine Hydrochloride 25 in 1 PACKAGE INJECTION 25 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70710-1988 HYDRALAZINE HYDROCHLORIDE INJECTION [ZYDUS PHARMACEUTICALS USA INC.] 1 Current NDC, 2 package rows 20250429_f0db9c3c-d841-46f9-8409-9ffca83d7a97.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 Sample Exclude flag Status 70710-1988-1 70710198801 1 mL in 1 VIAL 1 ml Historical 70710-1988-7 70710198807 25 VIAL in 1 PACKAGE (70710-1988-7) / 1 mL in 1 VIAL (70710-1988-1) 25 vial 2025-04-28 No No Current