phenylephrine hydrochloride

Generic: phenylephrine hydrochloride

Labeler: eugia us llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name phenylephrine hydrochloride
Generic Name phenylephrine hydrochloride
Labeler eugia us llc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

phenylephrine hydrochloride 10 mg/mL

Manufacturer
Eugia US LLC

Identifiers & Regulatory

Product NDC 55150-300
Product ID 55150-300_a816de08-7a48-43df-a09b-f1f342a230d5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210696
Listing Expiration 2027-12-31
Marketing Start 2021-01-07

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55150300
Hyphenated Format 55150-300

Supplemental Identifiers

RxCUI
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 ANDA210696 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 25 VIAL, SINGLE-DOSE in 1 CARTON (55150-300-25) / 1 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

55150-300-25 25 VIAL, SINGLE-DOSE in 1 CARTON (55150-300-25) / 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": "a816de08-7a48-43df-a09b-f1f342a230d5", "openfda": {"unii": ["04JA59TNSJ"], "rxcui": ["1666372"], "spl_set_id": ["c2ba1b3e-94bc-494d-b0fe-4ab9dd61dddc"], "manufacturer_name": ["Eugia US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (55150-300-25)  / 1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "55150-300-25", "marketing_start_date": "20210107"}], "brand_name": "Phenylephrine Hydrochloride", "product_id": "55150-300_a816de08-7a48-43df-a09b-f1f342a230d5", "dosage_form": "INJECTION", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "55150-300", "generic_name": "Phenylephrine Hydrochloride", "labeler_name": "Eugia US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Phenylephrine Hydrochloride", "active_ingredients": [{"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/mL"}], "application_number": "ANDA210696", "marketing_category": "ANDA", "marketing_start_date": "20210107", "listing_expiration_date": "20271231"}