Home NDC 71335-1236-5 HydrALAZINE Hydrochloride
Product NDC 71335-1236
Requested package NDC 71335-1236-5
11-digit product format 713351236
Labeler code 71335
Product ID 71335-1236_47ad263b-ad3d-4f98-b0aa-d9e82ab6cb67
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name HydrALAZINE Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA200770
Marketing category ANDA
Marketing start 2013-06-30
Marketing end 0000-00-00
Substance HYDRALAZINE HYDROCHLORIDE
Active strength 50 mg/1
Pharmacologic classes Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
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 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 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 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.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Related label table NDC Related label 71335-1236-1 HydrALAZINE HYDROCHLORIDE TABLETS, USP 71335-1236-1 HydrALAZINE HYDROCHLORIDE TABLETS, USP 71335-1236-2 HydrALAZINE HYDROCHLORIDE TABLETS, USP 71335-1236-2 HydrALAZINE HYDROCHLORIDE TABLETS, USP 71335-1236-3 HydrALAZINE HYDROCHLORIDE TABLETS, USP 71335-1236-3 HydrALAZINE HYDROCHLORIDE TABLETS, USP 71335-1236-4 HydrALAZINE HYDROCHLORIDE TABLETS, USP 71335-1236-4 HydrALAZINE HYDROCHLORIDE TABLETS, USP 71335-1236-5 HydrALAZINE HYDROCHLORIDE TABLETS, USP 71335-1236-5 HydrALAZINE HYDROCHLORIDE TABLETS, USP
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71335-1236-1 HydrALAZINE Hydrochloride 30 in 1 BOTTLE TABLET 30 2 71335-1236-2 HydrALAZINE Hydrochloride 60 in 1 BOTTLE TABLET 60 2 71335-1236-3 HydrALAZINE Hydrochloride 120 in 1 BOTTLE TABLET 120 2 71335-1236-4 HydrALAZINE Hydrochloride 90 in 1 BOTTLE TABLET 90 2 71335-1236-5 HydrALAZINE Hydrochloride 10 in 1 BOTTLE TABLET 10 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-1236 HYDRALAZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] 2 Legacy NDC, 5 package rows 20220204_47ad263b-ad3d-4f98-b0aa-d9e82ab6cb67.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 71335-1236-5 71335123605 10 TABLET in 1 BOTTLE (71335-1236-5) 10 tablet 2021-12-28 0000-00-00 No No Current