phenylephrine hydrochloride

Generic: phenylephrine hydrochloride

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

Drug Facts

Product Profile

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

phenylephrine hydrochloride 10 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-751
Product ID 63323-751_5a89afc5-7043-4297-8f6b-f8858e9f7a83
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210666
Listing Expiration 2026-12-31
Marketing Start 2019-05-25

Pharmacologic Class

Classes
adrenergic alpha1-agonists [moa] alpha-1 adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323751
Hyphenated Format 63323-751

Supplemental Identifiers

RxCUI
1666372
UPC
0363323751050 0363323751104
UNII
04JA59TNSJ

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 phenylephrine hydrochloride (source: ndc)
Generic Name phenylephrine hydrochloride (source: ndc)
Application Number ANDA210666 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (63323-751-05) / 5 mL in 1 VIAL, PHARMACY BULK PACKAGE
  • 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (63323-751-10) / 10 mL in 1 VIAL, PHARMACY BULK PACKAGE
source: ndc

Packages (2)

63323-751-05 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (63323-751-05) / 5 mL in 1 VIAL, PHARMACY BULK PACKAGE 63323-751-10 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (63323-751-10) / 10 mL in 1 VIAL, PHARMACY BULK PACKAGE

Ingredients (1)

phenylephrine hydrochloride (10 mg/mL)

Linked Drug Pages (3)

Phenylephrine Hydrochloride ndc-match (0.9) Phenylephrine Hydrochloride ndc-match (0.9) Phenylephrine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "5a89afc5-7043-4297-8f6b-f8858e9f7a83", "openfda": {"upc": ["0363323751050", "0363323751104"], "unii": ["04JA59TNSJ"], "rxcui": ["1666372"], "spl_set_id": ["c7026b15-1228-4acb-beed-4474fcdbb972"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (63323-751-05)  / 5 mL in 1 VIAL, PHARMACY BULK PACKAGE", "package_ndc": "63323-751-05", "marketing_start_date": "20190525"}, {"sample": false, "description": "1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (63323-751-10)  / 10 mL in 1 VIAL, PHARMACY BULK PACKAGE", "package_ndc": "63323-751-10", "marketing_start_date": "20190525"}], "brand_name": "Phenylephrine Hydrochloride", "product_id": "63323-751_5a89afc5-7043-4297-8f6b-f8858e9f7a83", "dosage_form": "INJECTION", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "63323-751", "generic_name": "Phenylephrine Hydrochloride", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Phenylephrine Hydrochloride", "active_ingredients": [{"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/mL"}], "application_number": "ANDA210666", "marketing_category": "ANDA", "marketing_start_date": "20190525", "listing_expiration_date": "20261231"}