hydralazine hydrochloride

Generic: hydralazine hydrochloride

Labeler: strides pharma science limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydralazine hydrochloride
Generic Name hydralazine hydrochloride
Labeler strides pharma science limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

hydralazine hydrochloride 10 mg/1

Manufacturer
Strides Pharma Science Limited

Identifiers & Regulatory

Product NDC 64380-733
Product ID 64380-733_4ca5f9d2-a4ec-4be1-865f-96a4615087b9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200770
Listing Expiration 2026-12-31
Marketing Start 2022-06-30

Pharmacologic Class

Classes
arteriolar vasodilation [pe] arteriolar vasodilator [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64380733
Hyphenated Format 64380-733

Supplemental Identifiers

RxCUI
905199 905222 905225 905395
UPC
0364380735069 0364380735083 0364380736066 0364380733065 0364380734086
UNII
FD171B778Y

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name hydralazine hydrochloride (source: ndc)
Generic Name hydralazine hydrochloride (source: ndc)
Application Number ANDA200770 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (64380-733-06)
  • 500 TABLET in 1 BOTTLE (64380-733-07)
  • 1000 TABLET in 1 BOTTLE (64380-733-08)
source: ndc

Packages (3)

64380-733-06 100 TABLET in 1 BOTTLE (64380-733-06) 64380-733-07 500 TABLET in 1 BOTTLE (64380-733-07) 64380-733-08 1000 TABLET in 1 BOTTLE (64380-733-08)

Ingredients (1)

hydralazine hydrochloride (10 mg/1)

Linked Drug Pages (1)

HydrALAZINE Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4ca5f9d2-a4ec-4be1-865f-96a4615087b9", "openfda": {"upc": ["0364380735069", "0364380735083", "0364380736066", "0364380733065", "0364380734086"], "unii": ["FD171B778Y"], "rxcui": ["905199", "905222", "905225", "905395"], "spl_set_id": ["b3d1786d-c3ff-42f1-a09f-37a9c9021e5a"], "manufacturer_name": ["Strides Pharma Science Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (64380-733-06)", "package_ndc": "64380-733-06", "marketing_start_date": "20220630"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (64380-733-07)", "package_ndc": "64380-733-07", "marketing_start_date": "20220630"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (64380-733-08)", "package_ndc": "64380-733-08", "marketing_start_date": "20220630"}], "brand_name": "HydrALAZINE Hydrochloride", "product_id": "64380-733_4ca5f9d2-a4ec-4be1-865f-96a4615087b9", "dosage_form": "TABLET", "pharm_class": ["Arteriolar Vasodilation [PE]", "Arteriolar Vasodilator [EPC]"], "product_ndc": "64380-733", "generic_name": "HydrALAZINE Hydrochloride", "labeler_name": "Strides Pharma Science Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "HydrALAZINE Hydrochloride", "active_ingredients": [{"name": "HYDRALAZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA200770", "marketing_category": "ANDA", "marketing_start_date": "20220630", "listing_expiration_date": "20261231"}