phenylephrine hydrochloride

Generic: phenylephrine hydrochloride

Labeler: leading pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name phenylephrine hydrochloride
Generic Name phenylephrine hydrochloride
Labeler leading pharma, llc
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

phenylephrine hydrochloride 25 mg/mL

Manufacturer
Leading Pharma, LLC

Identifiers & Regulatory

Product NDC 69315-323
Product ID 69315-323_a73191de-c6e0-455f-8e26-f90a529cac56
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215183
Listing Expiration 2026-12-31
Marketing Start 2024-09-05

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69315323
Hyphenated Format 69315-323

Supplemental Identifiers

RxCUI
1234571 1234579
UPC
0369315324059 0369315323083 0369315323151
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 ANDA215183 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 25 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (69315-323-08) / 2 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (69315-323-15) / 15 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (2)

69315-323-08 1 BOTTLE, DROPPER in 1 CARTON (69315-323-08) / 2 mL in 1 BOTTLE, DROPPER 69315-323-15 1 BOTTLE, DROPPER in 1 CARTON (69315-323-15) / 15 mL in 1 BOTTLE, DROPPER

Ingredients (1)

phenylephrine hydrochloride (25 mg/mL)

Linked Drug Pages (1)

PHENYLEPHRINE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "a73191de-c6e0-455f-8e26-f90a529cac56", "openfda": {"upc": ["0369315324059", "0369315323083", "0369315323151"], "unii": ["04JA59TNSJ"], "rxcui": ["1234571", "1234579"], "spl_set_id": ["7543f7e8-fd5f-46d5-a310-ebae71becf44"], "manufacturer_name": ["Leading Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (69315-323-08)  / 2 mL in 1 BOTTLE, DROPPER", "package_ndc": "69315-323-08", "marketing_start_date": "20240905"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (69315-323-15)  / 15 mL in 1 BOTTLE, DROPPER", "package_ndc": "69315-323-15", "marketing_start_date": "20240905"}], "brand_name": "PHENYLEPHRINE HYDROCHLORIDE", "product_id": "69315-323_a73191de-c6e0-455f-8e26-f90a529cac56", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "69315-323", "generic_name": "PHENYLEPHRINE HYDROCHLORIDE", "labeler_name": "Leading Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PHENYLEPHRINE HYDROCHLORIDE", "active_ingredients": [{"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "25 mg/mL"}], "application_number": "ANDA215183", "marketing_category": "ANDA", "marketing_start_date": "20240905", "listing_expiration_date": "20261231"}