Home NDC 17478-934 Hydralazine Hydrochloride
Product NDC 17478-934
11-digit product format 174780934
Labeler code 17478
Product ID 17478-934_202642d1-3384-4cc6-8831-e2b35a6812e8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydralazine Hydrochloride
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Akorn
Application ANDA040730
Marketing category ANDA
Marketing start 2009-05-01
Marketing end 0000-00-00
Substance HYDRALAZINE HYDROCHLORIDE
Active strength 20 mg/mL
Pharmacologic classes Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
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 · 60 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A040730-001 HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2009-04-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040730-001 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 A040730-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2009-04-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040730-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2009-04-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040730-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2009-04-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040730-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2009-04-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040730-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2009-04-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040730-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2009-04-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040730-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2009-04-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040730-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2009-04-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040730-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2009-04-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040730-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2009-04-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040730-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 2009-04-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040730-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 2009-04-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040730-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 2009-04-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040730-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 2009-04-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040730-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 2009-04-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040730-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 2009-04-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040730-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 2009-04-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040730-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 2009-04-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040730-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 2009-04-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040730-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 2009-04-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040730-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 2009-04-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040730-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 2009-04-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040730-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 2009-04-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040730-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 2009-04-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040730-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 2009-04-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040730-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 2009-04-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040730-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 2009-04-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040730-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 2009-04-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040730-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 2009-04-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040730-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 2009-04-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040730-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 2009-04-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040730-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 2009-04-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040730-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 2009-04-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040730-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 2009-04-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040730-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 2009-04-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040730-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 2009-04-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040730-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 2009-04-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040730-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 2009-04-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040730-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 2009-04-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A040730-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP RS 2009-04-21 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 17478-934-01 Hydralazine Hydrochloride 1 mL in 1 VIAL, SINGLE-DOSE INJECTION 1 14 17478-934-10 Hydralazine Hydrochloride 1 mL in 1 VIAL, SINGLE-DOSE INJECTION 1 14 17478-934-10 Hydralazine Hydrochloride 10 in 1 CARTON INJECTION 10 14 17478-934-15 Hydralazine Hydrochloride 1 mL in 1 VIAL, SINGLE-DOSE INJECTION 1 14 17478-934-15 Hydralazine Hydrochloride 25 in 1 CARTON INJECTION 25 14
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Hydralazine Hydrochloride ACTIVE INGREDIENT FD171B778Y HYDRALAZINE HYDROCHLORIDE INJECTION [AKORN, INC.] 5 Hydralazine ACTIVE MOIETY 26NAK24LS8 HYDRALAZINE HYDROCHLORIDE INJECTION [AKORN, INC.] 5 Hydrochloric Acid INACTIVE INGREDIENT QTT17582CB HYDRALAZINE HYDROCHLORIDE INJECTION [AKORN, INC.] 5 Methylparaben INACTIVE INGREDIENT A2I8C7HI9T HYDRALAZINE HYDROCHLORIDE INJECTION [AKORN, INC.] 5 Propylene Glycol INACTIVE INGREDIENT 6DC9Q167V3 HYDRALAZINE HYDROCHLORIDE INJECTION [AKORN, INC.] 5 Propylparaben INACTIVE INGREDIENT Z8IX2SC1OH HYDRALAZINE HYDROCHLORIDE INJECTION [AKORN, INC.] 5 Sodium Hydroxide INACTIVE INGREDIENT 55X04QC32I HYDRALAZINE HYDROCHLORIDE INJECTION [AKORN, INC.] 5 Water INACTIVE INGREDIENT 059QF0KO0R HYDRALAZINE HYDROCHLORIDE INJECTION [AKORN, INC.] 5 HYDRALAZINE HYDROCHLORIDE ACTIVE INGREDIENT FD171B778Y HYDRALAZINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH] 1 HYDRALAZINE HYDROCHLORIDE ACTIVE INGREDIENT FD171B778Y HYDRALAZINE HYDROCHLORIDE INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 HYDRALAZINE ACTIVE MOIETY 26NAK24LS8 HYDRALAZINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH] 1 HYDRALAZINE ACTIVE MOIETY 26NAK24LS8 HYDRALAZINE HYDROCHLORIDE INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB HYDRALAZINE HYDROCHLORIDE INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB HYDRALAZINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T HYDRALAZINE HYDROCHLORIDE INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T HYDRALAZINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 HYDRALAZINE HYDROCHLORIDE INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 HYDRALAZINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH HYDRALAZINE HYDROCHLORIDE INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH HYDRALAZINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I HYDRALAZINE HYDROCHLORIDE INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I HYDRALAZINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH] 1 WATER INACTIVE INGREDIENT 059QF0KO0R HYDRALAZINE HYDROCHLORIDE INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R HYDRALAZINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 17478-934 HYDRALAZINE HYDROCHLORIDE INJECTION [AKORN] 14 Legacy NDC, 5 package rows 20220914_e31239e0-8c5a-4d10-9404-af32278484a3.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 Marketing start Marketing end Sample Exclude flag Status 17478-934-01 17478093401 10 VIAL, SINGLE-DOSE in 1 CARTON (17478-934-01) > 1 mL in 1 VIAL, SINGLE-DOSE 2009-05-01 0000-00-00 No No Current 17478-934-10 17478093410 10 VIAL, SINGLE-DOSE in 1 CARTON (17478-934-10) > 1 mL in 1 VIAL, SINGLE-DOSE 2009-05-01 0000-00-00 No No Current 17478-934-15 17478093415 25 VIAL, SINGLE-DOSE in 1 CARTON (17478-934-15) > 1 mL in 1 VIAL, SINGLE-DOSE 2009-05-01 0000-00-00 No No Current