phenylephrine hydrochloride

Generic: phenylephrine hydrochloride

Labeler: xellia pharmaceuticals usa llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name phenylephrine hydrochloride
Generic Name phenylephrine hydrochloride
Labeler xellia pharmaceuticals usa llc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

phenylephrine hydrochloride 100 mg/10mL

Manufacturer
Xellia Pharmaceuticals USA LLC

Identifiers & Regulatory

Product NDC 70594-065
Product ID 70594-065_69ee5794-96b0-4975-aadd-d8dbcc73ca3f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213318
Listing Expiration 2026-12-31
Marketing Start 2022-01-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70594065
Hyphenated Format 70594-065

Supplemental Identifiers

RxCUI
1232651 1666372
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 ANDA213318 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/10mL
source: ndc
Packaging
  • 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (70594-065-01) / 10 mL in 1 VIAL, PHARMACY BULK PACKAGE
  • 10 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (70594-065-02) / 10 mL in 1 VIAL, PHARMACY BULK PACKAGE
source: ndc

Packages (2)

70594-065-01 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (70594-065-01) / 10 mL in 1 VIAL, PHARMACY BULK PACKAGE 70594-065-02 10 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (70594-065-02) / 10 mL in 1 VIAL, PHARMACY BULK PACKAGE

Ingredients (1)

phenylephrine hydrochloride (100 mg/10mL)

Linked Drug Pages (1)

Phenylephrine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "69ee5794-96b0-4975-aadd-d8dbcc73ca3f", "openfda": {"unii": ["04JA59TNSJ"], "rxcui": ["1232651", "1666372"], "spl_set_id": ["abd39d9c-fcda-4d01-8a58-1d54ba7ac651"], "manufacturer_name": ["Xellia Pharmaceuticals USA LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (70594-065-01)  / 10 mL in 1 VIAL, PHARMACY BULK PACKAGE", "package_ndc": "70594-065-01", "marketing_start_date": "20220101"}, {"sample": false, "description": "10 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (70594-065-02)  / 10 mL in 1 VIAL, PHARMACY BULK PACKAGE", "package_ndc": "70594-065-02", "marketing_start_date": "20220101"}], "brand_name": "Phenylephrine Hydrochloride", "product_id": "70594-065_69ee5794-96b0-4975-aadd-d8dbcc73ca3f", "dosage_form": "INJECTION", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "70594-065", "generic_name": "PHENYLEPHRINE HYDROCHLORIDE", "labeler_name": "Xellia Pharmaceuticals USA LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Phenylephrine Hydrochloride", "active_ingredients": [{"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "100 mg/10mL"}], "application_number": "ANDA213318", "marketing_category": "ANDA", "marketing_start_date": "20220101", "listing_expiration_date": "20261231"}