Home NDC 64380-735 HydrALAZINE Hydrochloride
Product NDC 64380-735
11-digit product format 643800735
Labeler code 64380
Product ID 64380-735_198e8715-f4c9-4b66-9e8e-61edab911f51
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name HydrALAZINE Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Strides Pharma Science Limited
Application ANDA200770
Marketing category ANDA
Marketing start 2013-06-30
Substance HYDRALAZINE HYDROCHLORIDE
Active strength 50 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 A200770-001 HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2013-05-03 A200770-002 HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2013-05-03 A200770-003 HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2013-05-03 A200770-004 HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 10MG TABLET / ORAL 2019-06-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 · 170 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 A200770-001 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2013-05-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 A200770-002 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2013-05-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 A200770-003 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2013-05-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 A200770-004 HYDRALAZINE HYDROCHLORIDE 10MG TABLET / ORAL 2019-06-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 A200770-001 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2013-05-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200770-002 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2013-05-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200770-003 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2013-05-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200770-004 HYDRALAZINE HYDROCHLORIDE 10MG TABLET / ORAL 2019-06-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A200770-001 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2013-05-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200770-002 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2013-05-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200770-003 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2013-05-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200770-004 HYDRALAZINE HYDROCHLORIDE 10MG TABLET / ORAL 2019-06-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200770-001 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2013-05-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200770-002 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2013-05-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200770-003 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2013-05-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200770-004 HYDRALAZINE HYDROCHLORIDE 10MG TABLET / ORAL 2019-06-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200770-001 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2013-05-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200770-002 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2013-05-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200770-003 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2013-05-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200770-004 HYDRALAZINE HYDROCHLORIDE 10MG TABLET / ORAL 2019-06-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200770-001 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2013-05-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200770-002 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2013-05-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200770-003 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2013-05-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200770-004 HYDRALAZINE HYDROCHLORIDE 10MG TABLET / ORAL 2019-06-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200770-001 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2013-05-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200770-002 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2013-05-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200770-003 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2013-05-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200770-004 HYDRALAZINE HYDROCHLORIDE 10MG TABLET / ORAL 2019-06-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200770-001 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2013-05-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200770-002 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2013-05-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200770-003 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2013-05-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200770-004 HYDRALAZINE HYDROCHLORIDE 10MG TABLET / ORAL 2019-06-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200770-001 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2013-05-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200770-002 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2013-05-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200770-003 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2013-05-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200770-004 HYDRALAZINE HYDROCHLORIDE 10MG TABLET / ORAL 2019-06-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200770-001 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2013-05-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200770-002 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2013-05-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200770-003 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2013-05-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200770-004 HYDRALAZINE HYDROCHLORIDE 10MG TABLET / ORAL 2019-06-25 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 131 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 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 64380-735-06 HydrALAZINE Hydrochloride 100 in 1 BOTTLE TABLET 100 12 64380-735-07 HydrALAZINE Hydrochloride 500 in 1 BOTTLE TABLET 500 12 64380-735-08 HydrALAZINE Hydrochloride 1000 in 1 BOTTLE TABLET 1000 12
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64380-735 HYDRALAZINE HYDROCHLORIDE TABLET [STRIDES PHARMA SCIENCE LIMITED] 12 Current NDC, Legacy NDC, 3 package rows 20220701_b3d1786d-c3ff-42f1-a09f-37a9c9021e5a.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 Units Marketing start Marketing end Sample Exclude flag Status 64380-735-06 64380073506 100 TABLET in 1 BOTTLE (64380-735-06) 100 tablet 2013-06-30 0000-00-00 No No Current 64380-735-07 64380073507 500 TABLET in 1 BOTTLE (64380-735-07) 500 tablet 2013-06-30 0000-00-00 No No Current 64380-735-08 64380073508 1000 TABLET in 1 BOTTLE (64380-735-08) 1000 tablet 2013-06-30 0000-00-00 No No Current