hydralazine hydrochloride

Generic: hydralazine hydrochloride

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydralazine hydrochloride
Generic Name hydralazine hydrochloride
Labeler fresenius kabi usa, llc
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

hydralazine hydrochloride 20 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-614
Product ID 63323-614_bf1b7c2f-535c-45bb-928a-65606d87685e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040388
Listing Expiration 2026-12-31
Marketing Start 2001-09-05

Pharmacologic Class

Classes
arteriolar vasodilation [pe] arteriolar vasodilator [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323614
Hyphenated Format 63323-614

Supplemental Identifiers

RxCUI
966571
UPC
0363323614034
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 ANDA040388 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 25 VIAL, SINGLE-DOSE in 1 CARTON (63323-614-06) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-614-03)
source: ndc

Packages (1)

63323-614-06 25 VIAL, SINGLE-DOSE in 1 CARTON (63323-614-06) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-614-03)

Ingredients (1)

hydralazine hydrochloride (20 mg/mL)

Linked Drug Pages (4)

hydrALAZINE Hydrochloride ndc-match (0.9) Hydralazine Hydrochloride ndc-match (0.9) Hydralazine Hydrochloride ndc-match (0.9) Hydralazine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "bf1b7c2f-535c-45bb-928a-65606d87685e", "openfda": {"upc": ["0363323614034"], "unii": ["FD171B778Y"], "rxcui": ["966571"], "spl_set_id": ["bf1b7c2f-535c-45bb-928a-65606d87685e"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (63323-614-06)  / 1 mL in 1 VIAL, SINGLE-DOSE (63323-614-03)", "package_ndc": "63323-614-06", "marketing_start_date": "20010905"}], "brand_name": "Hydralazine Hydrochloride", "product_id": "63323-614_bf1b7c2f-535c-45bb-928a-65606d87685e", "dosage_form": "INJECTION", "pharm_class": ["Arteriolar Vasodilation [PE]", "Arteriolar Vasodilator [EPC]"], "product_ndc": "63323-614", "generic_name": "HYDRALAZINE HYDROCHLORIDE", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydralazine Hydrochloride", "active_ingredients": [{"name": "HYDRALAZINE HYDROCHLORIDE", "strength": "20 mg/mL"}], "application_number": "ANDA040388", "marketing_category": "ANDA", "marketing_start_date": "20010905", "listing_expiration_date": "20261231"}