Home NDC 71288-205-02 HYDRALAZINE HYDROCHLORIDE
Product NDC 71288-205
Requested package NDC 71288-205-02
11-digit product format 712880205
Labeler code 71288
Product ID 71288-205_2926d221-0ca5-4379-ac53-773051ec5c79
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name HYDRALAZINE HYDROCHLORIDE
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Meitheal Pharmaceuticals Inc.
Application ANDA217501
Marketing category ANDA
Marketing start 2025-06-02
Substance HYDRALAZINE HYDROCHLORIDE
Active strength 20 mg/mL
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217501-001 HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2025-06-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217501-001 AP
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.
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 A217501-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2025-06-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217501-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2025-06-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217501-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2025-06-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217501-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2025-06-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217501-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2025-06-02 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217501-001 HYDRALAZINE HYDROCHLORIDE 20MG/ML INJECTABLE / INJECTION AP 2025-06-02 a50c72e98297…
Observed Orange Book normalized TE history# 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 20 mg/mL
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 966571 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 71288-205-01 HYDRALAZINE HYDROCHLORIDE 1 mL in 1 VIAL, SINGLE-DOSE INJECTION 1 4 71288-205-02 HYDRALAZINE HYDROCHLORIDE 25 in 1 CARTON INJECTION 25 4
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 Marketing start Sample Exclude flag Status 71288-205-02 71288020502 25 VIAL, SINGLE-DOSE in 1 CARTON (71288-205-02) / 1 mL in 1 VIAL, SINGLE-DOSE (71288-205-01) 2025-06-02 No No Current