Home NDC 72189-013 HYDRALAZINE HYDROCHLORIDE
Product NDC 72189-013
11-digit product format 721890013
Labeler code 72189
Product ID 72189-013_8d2d75b7-1e0c-44fd-e053-2a95a90a6fdb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name HYDRALAZINE HYDROCHLORIDE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Direct_Rx
Application ANDA086242
Marketing category ANDA
Marketing start 2019-07-08
Marketing end 0000-00-00
Substance HYDRALAZINE HYDROCHLORIDE
Active strength 100 mg/1
Pharmacologic classes Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]
NDC exclude flag No
Listing certified through 2020-12-31
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 Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 72189-013-60 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 72189-013-60 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 72189-013-60 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 72189-013-60 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 72189-013-60 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 72189-013-60 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 72189-013-60 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 72189-013-60 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 72189-013-60 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 72189-013-60 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 72189-013-60 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 72189-013-60 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 72189-013-60 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 72189-013-60 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 72189-013-60 1332a3947898…d4bfe170f9cd…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A086242-001 HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 10MG TABLET / ORAL 2010-02-04 A086242-002 HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL Approved before 1982 A086242-003 HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL Approved before 1982 A086242-004 HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL 2010-02-04
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 5 · 172 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 A086242-001 HYDRALAZINE HYDROCHLORIDE 10MG TABLET / ORAL 2010-02-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 A086242-002 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 A086242-003 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 A086242-004 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL 2010-02-04 84e616aacf4f…2026-08-18 06:07:40 2026-07 A086242-001 HYDRALAZINE HYDROCHLORIDE 10MG TABLET / ORAL 2010-02-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A086242-002 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A086242-003 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A086242-004 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL 2010-02-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A086242-001 HYDRALAZINE HYDROCHLORIDE 10MG TABLET / ORAL AA 2010-02-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A086242-002 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A086242-003 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A086242-004 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2010-02-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A086242-001 HYDRALAZINE HYDROCHLORIDE 10MG TABLET / ORAL AA 2010-02-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A086242-002 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A086242-003 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A086242-004 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2010-02-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A086242-001 HYDRALAZINE HYDROCHLORIDE 10MG TABLET / ORAL AA 2010-02-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A086242-002 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A086242-003 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A086242-004 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2010-02-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A086242-001 HYDRALAZINE HYDROCHLORIDE 10MG TABLET / ORAL AA 2010-02-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A086242-002 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A086242-003 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A086242-004 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2010-02-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A086242-001 HYDRALAZINE HYDROCHLORIDE 10MG TABLET / ORAL AA 2010-02-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A086242-002 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A086242-003 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A086242-004 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2010-02-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A086242-001 HYDRALAZINE HYDROCHLORIDE 10MG TABLET / ORAL AA 2010-02-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A086242-002 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A086242-003 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A086242-004 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2010-02-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A086242-001 HYDRALAZINE HYDROCHLORIDE 10MG TABLET / ORAL AA 2010-02-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A086242-002 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A086242-003 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A086242-004 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2010-02-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A086242-001 HYDRALAZINE HYDROCHLORIDE 10MG TABLET / ORAL AA 2010-02-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A086242-002 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A086242-003 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A086242-004 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2010-02-04 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 4 · 160 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 72189-013-60 HYDRALAZINE HYDROCHLORIDE 60 in 1 BOTTLE TABLET, FILM COATED 60 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72189-013 HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT_RX] 1 Legacy NDC, 1 package rows 20190709_8d2d75b7-1e0b-44fd-e053-2a95a90a6fdb.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 Marketing start Marketing end Sample Exclude flag Status 72189-013-60 72189001360 60 TABLET, FILM COATED in 1 BOTTLE (72189-013-60) 2019-07-08 0000-00-00 No No Current