Home DailyMed 4acae8a5-03d0-4acf-ab99-7ec88a803202 National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2012-07-24
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 01:40:51 Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 45 .
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 · 180 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 2026-11-14 07:37:17 2026-10 A086242-001 HYDRALAZINE HYDROCHLORIDE 10MG TABLET / ORAL 2010-02-04 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A086242-002 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL Approved before 1982 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A086242-003 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL Approved before 1982 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A086242-004 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL 2010-02-04 d4dbc9d85df4…2026-10-15 13:18:30 2026-09 A086242-001 HYDRALAZINE HYDROCHLORIDE 10MG TABLET / ORAL 2010-02-04 c2088c7a36db…2026-10-15 13:18:30 2026-09 A086242-002 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL Approved before 1982 c2088c7a36db…2026-10-15 13:18:30 2026-09 A086242-003 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL Approved before 1982 c2088c7a36db…2026-10-15 13:18:30 2026-09 A086242-004 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL 2010-02-04 c2088c7a36db…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 160 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.