phenylephrine hydrochloride

Generic: phenylephrine hydrochloride

Labeler: propharma distribution
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name phenylephrine hydrochloride
Generic Name phenylephrine hydrochloride
Labeler propharma distribution
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

phenylephrine hydrochloride 10 mg/mL

Manufacturer
ProPharma Distribution

Identifiers & Regulatory

Product NDC 84549-621
Product ID 84549-621_463d1c23-2403-026d-e063-6394a90a3bf4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217069
Listing Expiration 2026-12-31
Marketing Start 2022-08-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 84549621
Hyphenated Format 84549-621

Supplemental Identifiers

RxCUI
1666372
UNII
04JA59TNSJ

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 ANDA217069 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 mL in 1 VIAL (84549-621-25)
source: ndc

Packages (1)

84549-621-25 1 mL in 1 VIAL (84549-621-25)

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": "463d1c23-2403-026d-e063-6394a90a3bf4", "openfda": {"unii": ["04JA59TNSJ"], "rxcui": ["1666372"], "spl_set_id": ["386663e8-f1f6-cf14-e063-6394a90a68df"], "manufacturer_name": ["ProPharma Distribution"]}, "finished": true, "packaging": [{"sample": false, "description": "1 mL in 1 VIAL (84549-621-25)", "package_ndc": "84549-621-25", "marketing_start_date": "20250827"}], "brand_name": "Phenylephrine hydrochloride", "product_id": "84549-621_463d1c23-2403-026d-e063-6394a90a3bf4", "dosage_form": "INJECTION", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "84549-621", "generic_name": "phenylephrine hydrochloride", "labeler_name": "ProPharma Distribution", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Phenylephrine hydrochloride", "active_ingredients": [{"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/mL"}], "application_number": "ANDA217069", "marketing_category": "ANDA", "marketing_start_date": "20220831", "listing_expiration_date": "20261231"}