Home NDC 70518-3852 Hydralazine Hydrochloride
Product NDC 70518-3852
11-digit product format 705183852
Labeler code 70518
Product ID 70518-3852_53d6aabf-10fe-a543-e063-6394a90a9e2a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydralazine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA205236
Marketing category ANDA
Marketing start 2023-09-03
Substance HYDRALAZINE HYDROCHLORIDE
Active strength 25 mg/1
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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A205236-001 HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 10MG TABLET / ORAL AA 2017-05-26 A205236-002 HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2017-05-26 A205236-003 HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2017-05-26 A205236-004 HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2017-05-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 A205236-001 HYDRALAZINE HYDROCHLORIDE 10MG TABLET / ORAL AA 2017-05-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A205236-002 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2017-05-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A205236-003 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2017-05-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A205236-004 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2017-05-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 A205236-001 HYDRALAZINE HYDROCHLORIDE 10MG TABLET / ORAL AA 2017-05-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205236-002 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2017-05-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205236-003 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2017-05-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205236-004 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2017-05-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205236-001 HYDRALAZINE HYDROCHLORIDE 10MG TABLET / ORAL AA 2017-05-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205236-002 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2017-05-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205236-003 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2017-05-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205236-004 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2017-05-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205236-001 HYDRALAZINE HYDROCHLORIDE 10MG TABLET / ORAL AA 2017-05-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205236-002 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2017-05-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205236-003 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2017-05-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205236-004 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2017-05-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205236-001 HYDRALAZINE HYDROCHLORIDE 10MG TABLET / ORAL AA 2017-05-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205236-002 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2017-05-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205236-003 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2017-05-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205236-004 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2017-05-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205236-001 HYDRALAZINE HYDROCHLORIDE 10MG TABLET / ORAL AA 2017-05-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205236-002 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2017-05-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205236-003 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2017-05-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205236-004 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2017-05-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205236-001 HYDRALAZINE HYDROCHLORIDE 10MG TABLET / ORAL AA 2017-05-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205236-002 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2017-05-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205236-003 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2017-05-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205236-004 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2017-05-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205236-001 HYDRALAZINE HYDROCHLORIDE 10MG TABLET / ORAL AA 2017-05-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205236-002 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2017-05-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205236-003 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2017-05-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205236-004 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2017-05-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205236-001 HYDRALAZINE HYDROCHLORIDE 10MG TABLET / ORAL AA 2017-05-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205236-002 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2017-05-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205236-003 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2017-05-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205236-004 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2017-05-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205236-001 HYDRALAZINE HYDROCHLORIDE 10MG TABLET / ORAL AA 2017-05-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205236-002 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2017-05-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205236-003 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2017-05-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205236-004 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2017-05-26 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 172 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 25 mg/1
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 905225 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 70518-3852-0 Hydralazine Hydrochloride 30 in 1 BLISTER PACK TABLET 30 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70518-3852 HYDRALAZINE HYDROCHLORIDE TABLET [REMEDYREPACK INC.] 2 Current NDC, 1 package rows 20240403_0d65e146-83e5-427f-ac06-04c0d8e72cea.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 2 of 2 · 21 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 70518-3852-0 70518385200 30 TABLET in 1 BLISTER PACK (70518-3852-0) 30 tablet 2023-09-03 No No Current