phenylephrine hydrochloride

Generic: phenylephrine hydrochloride

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

Drug Facts

Product Profile

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

phenylephrine hydrochloride 100 mg/10mL

Manufacturer
Armas Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 72485-506
Product ID 72485-506_16c02d53-fd3f-4fd7-abbe-f1358ea0891f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213318
Listing Expiration 2026-12-31
Marketing Start 2023-03-28

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72485506
Hyphenated Format 72485-506

Supplemental Identifiers

RxCUI
1232651 1666372
UPC
0372485506019 0372485504251
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 (72485-506-01) / 10 mL in 1 VIAL, PHARMACY BULK PACKAGE
source: ndc

Packages (1)

72485-506-01 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (72485-506-01) / 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": "16c02d53-fd3f-4fd7-abbe-f1358ea0891f", "openfda": {"upc": ["0372485506019", "0372485504251"], "unii": ["04JA59TNSJ"], "rxcui": ["1232651", "1666372"], "spl_set_id": ["16c02d53-fd3f-4fd7-abbe-f1358ea0891f"], "manufacturer_name": ["Armas Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (72485-506-01)  / 10 mL in 1 VIAL, PHARMACY BULK PACKAGE", "package_ndc": "72485-506-01", "marketing_start_date": "20230328"}], "brand_name": "PHENYLEPHRINE HYDROCHLORIDE", "product_id": "72485-506_16c02d53-fd3f-4fd7-abbe-f1358ea0891f", "dosage_form": "INJECTION", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "72485-506", "generic_name": "PHENYLEPHRINE HYDROCHLORIDE", "labeler_name": "Armas Pharmaceuticals Inc.", "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": "20230328", "listing_expiration_date": "20261231"}