Home NDC 67877-291 Hydralazine Hydrochloride
Product NDC 67877-291
11-digit product format 678770291
Labeler code 67877
Product ID 67877-291_26a904df-7070-489e-b0e0-67167a817944
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydralazine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Ascend Laboratories, LLC
Application ANDA200737
Marketing category ANDA
Marketing start 2009-11-24
Substance HYDRALAZINE HYDROCHLORIDE
Active strength 50 mg/1
Pharmacologic classes Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
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 A200737-001 HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 10MG TABLET / ORAL AA 2012-12-07 A200737-002 HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2012-12-07 A200737-003 HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2012-12-07 A200737-004 HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2012-12-07
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 A200737-001 HYDRALAZINE HYDROCHLORIDE 10MG TABLET / ORAL AA 2012-12-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 A200737-002 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2012-12-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 A200737-003 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2012-12-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 A200737-004 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2012-12-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 A200737-001 HYDRALAZINE HYDROCHLORIDE 10MG TABLET / ORAL AA 2012-12-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200737-002 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2012-12-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200737-003 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2012-12-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200737-004 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2012-12-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A200737-001 HYDRALAZINE HYDROCHLORIDE 10MG TABLET / ORAL AA 2012-12-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200737-002 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2012-12-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200737-003 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2012-12-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200737-004 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2012-12-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200737-001 HYDRALAZINE HYDROCHLORIDE 10MG TABLET / ORAL AA 2012-12-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200737-002 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2012-12-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200737-003 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2012-12-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200737-004 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2012-12-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200737-001 HYDRALAZINE HYDROCHLORIDE 10MG TABLET / ORAL AA 2012-12-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200737-002 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2012-12-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200737-003 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2012-12-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200737-004 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2012-12-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200737-001 HYDRALAZINE HYDROCHLORIDE 10MG TABLET / ORAL AA 2012-12-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200737-002 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2012-12-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200737-003 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2012-12-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200737-004 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2012-12-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200737-001 HYDRALAZINE HYDROCHLORIDE 10MG TABLET / ORAL AA 2012-12-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200737-002 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2012-12-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200737-003 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2012-12-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200737-004 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2012-12-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200737-001 HYDRALAZINE HYDROCHLORIDE 10MG TABLET / ORAL AA 2012-12-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200737-002 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2012-12-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200737-003 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2012-12-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200737-004 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2012-12-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200737-001 HYDRALAZINE HYDROCHLORIDE 10MG TABLET / ORAL AA 2012-12-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200737-002 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2012-12-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200737-003 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2012-12-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200737-004 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2012-12-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200737-001 HYDRALAZINE HYDROCHLORIDE 10MG TABLET / ORAL AA 2012-12-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200737-002 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2012-12-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200737-003 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2012-12-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200737-004 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2012-12-07 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 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDRALAZINE HYDROCHLORIDE 50 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 905199 Internal RxNorm lookup 905222 Internal RxNorm lookup 905225 Internal RxNorm lookup 905395 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 67877-291-01 Hydralazine Hydrochloride 100 in 1 BOTTLE TABLET 100 5 67877-291-05 Hydralazine Hydrochloride 500 in 1 BOTTLE TABLET 500 5 67877-291-10 Hydralazine Hydrochloride 1000 in 1 BOTTLE TABLET 1000 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded HYDRALAZINE HYDROCHLORIDE ACTIVE INGREDIENT FD171B778Y HYDRALAZINE HYDROCHLORIDE TABLET [ASCEND LABORATORIES, LLC] 4 Hydralazine ACTIVE MOIETY 26NAK24LS8 HYDRALAZINE HYDROCHLORIDE TABLET [ASCEND LABORATORIES, LLC] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U HYDRALAZINE HYDROCHLORIDE TABLET [ASCEND LABORATORIES, LLC] 4 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 HYDRALAZINE HYDROCHLORIDE TABLET [ASCEND LABORATORIES, LLC] 4 MANNITOL INACTIVE INGREDIENT 3OWL53L36A HYDRALAZINE HYDROCHLORIDE TABLET [ASCEND LABORATORIES, LLC] 4 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X HYDRALAZINE HYDROCHLORIDE TABLET [ASCEND LABORATORIES, LLC] 4 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 HYDRALAZINE HYDROCHLORIDE TABLET [ASCEND LABORATORIES, LLC] 4 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 HYDRALAZINE HYDROCHLORIDE TABLET [ASCEND LABORATORIES, LLC] 4 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP HYDRALAZINE HYDROCHLORIDE TABLET [ASCEND LABORATORIES, LLC] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67877-291 HYDRALAZINE HYDROCHLORIDE TABLET [ASCEND LABORATORIES, LLC] 5 Current NDC, Legacy NDC, 3 package rows 20171229_e7bfec3d-5222-4a26-8f99-6c2a28e14aa6.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 Units Marketing start Marketing end Sample Exclude flag Status 67877-291-01 67877029101 100 TABLET in 1 BOTTLE (67877-291-01) 100 tablet 2009-11-24 0000-00-00 No No Current 67877-291-05 67877029105 500 TABLET in 1 BOTTLE (67877-291-05) 500 tablet 2009-11-24 0000-00-00 No No Current 67877-291-10 67877029110 1000 TABLET in 1 BOTTLE (67877-291-10) 1000 tablet 2009-11-24 0000-00-00 No No Current