phenylephrine hydrochloride

Generic: phenylephrine hydrochloride

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

Drug Facts

Product Profile

Brand Name phenylephrine hydrochloride
Generic Name phenylephrine hydrochloride
Labeler camber pharmaceuticals, inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

phenylephrine hydrochloride 10 mg/mL

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-345
Product ID 31722-345_23a5b85f-4414-6b2b-e063-6394a90aee77
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218110
Listing Expiration 2026-12-31
Marketing Start 2024-05-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 31722345
Hyphenated Format 31722-345

Supplemental Identifiers

RxCUI
1232651 1666372
UPC
0331722343312 0331722344050 0331722345101
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 ANDA218110 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (31722-345-10) / 10 mL in 1 VIAL, PHARMACY BULK PACKAGE
  • 10 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (31722-345-31) / 10 mL in 1 VIAL, PHARMACY BULK PACKAGE
source: ndc

Packages (2)

31722-345-10 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (31722-345-10) / 10 mL in 1 VIAL, PHARMACY BULK PACKAGE 31722-345-31 10 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (31722-345-31) / 10 mL in 1 VIAL, PHARMACY BULK PACKAGE

Ingredients (1)

phenylephrine hydrochloride (10 mg/mL)

Linked Drug Pages (1)

PHENYLEPHRINE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "23a5b85f-4414-6b2b-e063-6394a90aee77", "openfda": {"upc": ["0331722343312", "0331722344050", "0331722345101"], "unii": ["04JA59TNSJ"], "rxcui": ["1232651", "1666372"], "spl_set_id": ["744da574-dfc9-4a22-8983-2ee15be2ea84"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (31722-345-10)  / 10 mL in 1 VIAL, PHARMACY BULK PACKAGE", "package_ndc": "31722-345-10", "marketing_start_date": "20240510"}, {"sample": false, "description": "10 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (31722-345-31)  / 10 mL in 1 VIAL, PHARMACY BULK PACKAGE", "package_ndc": "31722-345-31", "marketing_start_date": "20240510"}], "brand_name": "PHENYLEPHRINE HYDROCHLORIDE", "product_id": "31722-345_23a5b85f-4414-6b2b-e063-6394a90aee77", "dosage_form": "INJECTION", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "31722-345", "generic_name": "PHENYLEPHRINE HYDROCHLORIDE", "labeler_name": "Camber Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PHENYLEPHRINE HYDROCHLORIDE", "active_ingredients": [{"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/mL"}], "application_number": "ANDA218110", "marketing_category": "ANDA", "marketing_start_date": "20240510", "listing_expiration_date": "20261231"}