Home NDC 0615-5649 Hydralazine Hydrochloride
Product NDC 0615-5649
11-digit product format 006155649
Labeler code 0615
Product ID 0615-5649_1cce9fcb-74f7-4f96-a546-5572b96d4d7c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydralazine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler NCS HealthCare of KY, Inc dba Vangard Labs
Application ANDA088391
Marketing category ANDA
Marketing start 1983-09-27
Marketing end 0000-00-00
Substance HYDRALAZINE HYDROCHLORIDE
Active strength 100 mg/1
Pharmacologic classes Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]
NDC exclude flag E
Listing certified through 2017-12-31
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 · 30 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0615-5649-39 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0615-5649-39 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0615-5649-39 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0615-5649-39 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0615-5649-39 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0615-5649-39 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0615-5649-39 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0615-5649-39 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0615-5649-39 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0615-5649-39 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0615-5649-39 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0615-5649-39 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 0615-5649-39 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 0615-5649-39 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 0615-5649-39 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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 A088391-001 HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL 1983-09-27
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 A088391-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL 1983-09-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A088391-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 1983-09-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A088391-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 1983-09-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A088391-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 1983-09-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A088391-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 1983-09-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A088391-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 1983-09-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A088391-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 1983-09-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A088391-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 1983-09-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A088391-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 1983-09-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A088391-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 1983-09-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A088391-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 1983-09-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A088391-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 1983-09-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A088391-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 1983-09-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A088391-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 1983-09-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A088391-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 1983-09-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A088391-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 1983-09-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A088391-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 1983-09-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A088391-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 1983-09-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A088391-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 1983-09-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A088391-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 1983-09-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A088391-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 1983-09-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A088391-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 1983-09-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A088391-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 1983-09-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A088391-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 1983-09-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A088391-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 1983-09-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A088391-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 1983-09-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A088391-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 1983-09-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A088391-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 1983-09-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A088391-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 1983-09-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A088391-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 1983-09-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A088391-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 1983-09-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A088391-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 1983-09-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A088391-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 1983-09-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A088391-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 1983-09-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A088391-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 1983-09-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A088391-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 1983-09-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A088391-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 1983-09-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A088391-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 1983-09-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A088391-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 1983-09-27 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A088391-001 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 1983-09-27 cb3db0bc1861…
Observed Orange Book normalized TE history# FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded HYDRALAZINE HYDROCHLORIDE ACTIVE INGREDIENT FD171B778Y HYDRALAZINE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 9 HYDRALAZINE ACTIVE MOIETY 26NAK24LS8 HYDRALAZINE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 9 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U HYDRALAZINE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 9 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA HYDRALAZINE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 9 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 HYDRALAZINE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 9 LACTOSE, UNSPECIFIED FORM INACTIVE INGREDIENT J2B2A4N98G HYDRALAZINE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 9 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 HYDRALAZINE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 9 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 HYDRALAZINE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 9 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP HYDRALAZINE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 9