hydralazine hydrochloride

Generic: hydralazine hydrochloride

Labeler: nucare pharmaceuticals,inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydralazine hydrochloride
Generic Name hydralazine hydrochloride
Labeler nucare pharmaceuticals,inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

hydralazine hydrochloride 100 mg/1

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-5285
Product ID 68071-5285_297a3678-170d-5f0f-e063-6394a90aec48
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040901
Listing Expiration 2026-12-31
Marketing Start 2010-01-01

Pharmacologic Class

Classes
arteriolar vasodilation [pe] arteriolar vasodilator [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 680715285
Hyphenated Format 68071-5285

Supplemental Identifiers

RxCUI
905222
UPC
0368071528510
UNII
FD171B778Y

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 ANDA040901 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (68071-5285-1)
source: ndc

Packages (1)

68071-5285-1 100 TABLET in 1 BOTTLE (68071-5285-1)

Ingredients (1)

hydralazine hydrochloride (100 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": "297a3678-170d-5f0f-e063-6394a90aec48", "openfda": {"upc": ["0368071528510"], "unii": ["FD171B778Y"], "rxcui": ["905222"], "spl_set_id": ["a862321d-ebc1-7676-e053-2995a90a5861"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68071-5285-1)", "package_ndc": "68071-5285-1", "marketing_start_date": "20200618"}], "brand_name": "Hydralazine Hydrochloride", "product_id": "68071-5285_297a3678-170d-5f0f-e063-6394a90aec48", "dosage_form": "TABLET", "pharm_class": ["Arteriolar Vasodilation [PE]", "Arteriolar Vasodilator [EPC]"], "product_ndc": "68071-5285", "generic_name": "Hydralazine Hydrochloride", "labeler_name": "NuCare Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydralazine Hydrochloride", "active_ingredients": [{"name": "HYDRALAZINE HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA040901", "marketing_category": "ANDA", "marketing_start_date": "20100101", "listing_expiration_date": "20261231"}