phenylephrine hydrochloride

Generic: phenylephrine hydrochloride

Labeler: somerset therapeutics, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name phenylephrine hydrochloride
Generic Name phenylephrine hydrochloride
Labeler somerset therapeutics, llc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

phenylephrine hydrochloride 50 mg/5mL

Manufacturer
Somerset Therapeutics, LLC

Identifiers & Regulatory

Product NDC 70069-812
Product ID 70069-812_18b65b44-fdd1-4385-b6f8-cf3cbdc8d0e6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213318
Listing Expiration 2026-12-31
Marketing Start 2023-07-17

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70069812
Hyphenated Format 70069-812

Supplemental Identifiers

RxCUI
1232651 1666372
UPC
0370069813010
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
  • 50 mg/5mL
source: ndc
Packaging
  • 10 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (70069-812-10) / 5 mL in 1 VIAL, PHARMACY BULK PACKAGE (70069-812-01)
source: ndc

Packages (1)

70069-812-10 10 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (70069-812-10) / 5 mL in 1 VIAL, PHARMACY BULK PACKAGE (70069-812-01)

Ingredients (1)

phenylephrine hydrochloride (50 mg/5mL)

Linked Drug Pages (1)

PHENYLEPHRINE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "18b65b44-fdd1-4385-b6f8-cf3cbdc8d0e6", "openfda": {"upc": ["0370069813010"], "unii": ["04JA59TNSJ"], "rxcui": ["1232651", "1666372"], "spl_set_id": ["18b65b44-fdd1-4385-b6f8-cf3cbdc8d0e6"], "manufacturer_name": ["Somerset Therapeutics, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (70069-812-10)  / 5 mL in 1 VIAL, PHARMACY BULK PACKAGE (70069-812-01)", "package_ndc": "70069-812-10", "marketing_start_date": "20230717"}], "brand_name": "PHENYLEPHRINE HYDROCHLORIDE", "product_id": "70069-812_18b65b44-fdd1-4385-b6f8-cf3cbdc8d0e6", "dosage_form": "INJECTION", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "70069-812", "generic_name": "PHENYLEPHRINE HYDROCHLORIDE", "labeler_name": "Somerset Therapeutics, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PHENYLEPHRINE HYDROCHLORIDE", "active_ingredients": [{"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "50 mg/5mL"}], "application_number": "ANDA213318", "marketing_category": "ANDA", "marketing_start_date": "20230717", "listing_expiration_date": "20261231"}