phenylephrine hydrochloride

Generic: phenylephrine hydrochloride

Labeler: hf acquisition co llc, dba healthfirst
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name phenylephrine hydrochloride
Generic Name phenylephrine hydrochloride
Labeler hf acquisition co llc, dba healthfirst
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

phenylephrine hydrochloride 10 mg/mL

Manufacturer
HF Acquisition Co LLC, DBA HealthFirst

Identifiers & Regulatory

Product NDC 51662-1576
Product ID 51662-1576_11fff86b-b35b-a576-e063-6394a90a1fa3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210665
Listing Expiration 2026-12-31
Marketing Start 2021-06-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 516621576
Hyphenated Format 51662-1576

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 ANDA210665 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 mL in 1 VIAL, SINGLE-DOSE (51662-1576-1)
  • 25 POUCH in 1 CASE (51662-1576-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1576-2) / 1 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (2)

51662-1576-1 1 mL in 1 VIAL, SINGLE-DOSE (51662-1576-1) 51662-1576-3 25 POUCH in 1 CASE (51662-1576-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1576-2) / 1 mL in 1 VIAL, SINGLE-DOSE

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": "11fff86b-b35b-a576-e063-6394a90a1fa3", "openfda": {"unii": ["04JA59TNSJ"], "rxcui": ["1666372"], "spl_set_id": ["c600fe14-40b6-2b5a-e053-2a95a90aff98"], "manufacturer_name": ["HF Acquisition Co LLC, DBA HealthFirst"]}, "finished": true, "packaging": [{"sample": false, "description": "1 mL in 1 VIAL, SINGLE-DOSE (51662-1576-1)", "package_ndc": "51662-1576-1", "marketing_start_date": "20210630"}, {"sample": false, "description": "25 POUCH in 1 CASE (51662-1576-3)  / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1576-2)  / 1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "51662-1576-3", "marketing_start_date": "20220710"}], "brand_name": "PHENYLEPHRINE HYDROCHLORIDE", "product_id": "51662-1576_11fff86b-b35b-a576-e063-6394a90a1fa3", "dosage_form": "INJECTION", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "51662-1576", "generic_name": "PHENYLEPHRINE HYDROCHLORIDE", "labeler_name": "HF Acquisition Co LLC, DBA HealthFirst", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PHENYLEPHRINE HYDROCHLORIDE", "active_ingredients": [{"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/mL"}], "application_number": "ANDA210665", "marketing_category": "ANDA", "marketing_start_date": "20210630", "listing_expiration_date": "20261231"}