Home NDC 75834-127-00 Hydralazine
Product NDC 75834-127
Requested package NDC 75834-127-00
11-digit product format 758340127
Labeler code 75834
Product ID 75834-127_379fe677-a8e7-4bfe-abcf-85283768c27b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name HYDRALAZINE HYDROCHLORIDE
Dosage form TABLET
Route ORAL
Labeler Nivagen Pharmaceuticals, Inc.
Application ANDA203845
Marketing category ANDA
Marketing start 2017-02-15
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 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 75834-127 75834-127-00 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…a55b01930146…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A203845-001 HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2014-09-18 A203845-002 HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2014-09-18 A203845-003 HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2014-09-18
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 4 · 129 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 A203845-001 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2014-09-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203845-002 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2014-09-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203845-003 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2014-09-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 A203845-001 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2014-09-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203845-002 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2014-09-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203845-003 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2014-09-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203845-001 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2014-09-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203845-002 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2014-09-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203845-003 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2014-09-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203845-001 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2014-09-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203845-002 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2014-09-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203845-003 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2014-09-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203845-001 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2014-09-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203845-002 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2014-09-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203845-003 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2014-09-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203845-001 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2014-09-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203845-002 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2014-09-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203845-003 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2014-09-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203845-001 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2014-09-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203845-002 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2014-09-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203845-003 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2014-09-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203845-001 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2014-09-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203845-002 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2014-09-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203845-003 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2014-09-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203845-001 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2014-09-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203845-002 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2014-09-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203845-003 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2014-09-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203845-001 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2014-09-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203845-002 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2014-09-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203845-003 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2014-09-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203845-001 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2014-09-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203845-002 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2014-09-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203845-003 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2014-09-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203845-001 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2014-09-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203845-002 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2014-09-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203845-003 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2014-09-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203845-001 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2014-09-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203845-002 HYDRALAZINE HYDROCHLORIDE 50MG TABLET / ORAL AA 2014-09-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203845-003 HYDRALAZINE HYDROCHLORIDE 100MG TABLET / ORAL AA 2014-09-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203845-001 HYDRALAZINE HYDROCHLORIDE 25MG TABLET / ORAL AA 2014-09-18 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 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, Effective, Related label table NDC Effective Related label 75834-127-00 2022-02-15 HYDRALAZINE HYDROCHLORIDE TABLETS, USP 75834-127-01 2022-02-15 HYDRALAZINE HYDROCHLORIDE TABLETS, USP 75834-127-00 2022-01-28 HYDRALAZINE HYDROCHLORIDE TABLETS, USP 75834-127-01 2022-01-28 HYDRALAZINE HYDROCHLORIDE TABLETS, USP 75834-127-00 2020-05-06 HYDRALAZINE HYDROCHLORIDE TABLETS, USP 75834-127-01 2020-05-06 HYDRALAZINE HYDROCHLORIDE TABLETS, USP 75834-127-00 2020-01-31 HYDRALAZINE HYDROCHLORIDE TABLETS, USP 75834-127-01 2020-01-31 HYDRALAZINE HYDROCHLORIDE TABLETS, USP
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 75834-127-00 Hydralazine 1000 in 1 BOTTLE TABLET 1000 3 75834-127-01 Hydralazine 100 in 1 BOTTLE TABLET 100 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 75834-127 HYDRALAZINE (HYDRALAZINE HYDROCHLORIDE) TABLET [NIVAGEN PHARMACEUTICALS, INC.] 3 Legacy NDC, 2 package rows 20220216_1fd8cf42-66ae-4af5-a5ae-7c9679a0e532.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 75834-127-00 75834012700 1000 TABLET in 1 BOTTLE (75834-127-00) 1000 tablet 2017-02-15 0000-00-00 No No Current