phenylephrine hydrochloride

Generic: phenylephrine hydrochloride

Labeler: bausch & lomb americas inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name phenylephrine hydrochloride
Generic Name phenylephrine hydrochloride
Labeler bausch & lomb americas inc.
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

phenylephrine hydrochloride 25 mg/mL

Manufacturer
Bausch & Lomb Americas Inc.

Identifiers & Regulatory

Product NDC 82260-102
Product ID 82260-102_278d0147-c5b0-4d85-80f5-500ec567feed
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA203510
Listing Expiration 2026-12-31
Marketing Start 2023-03-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82260102
Hyphenated Format 82260-102

Supplemental Identifiers

RxCUI
1234579
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 NDA203510 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 25 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (82260-102-10) / 10 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (82260-102-15) / 15 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (2)

82260-102-10 1 BOTTLE, DROPPER in 1 CARTON (82260-102-10) / 10 mL in 1 BOTTLE, DROPPER 82260-102-15 1 BOTTLE, DROPPER in 1 CARTON (82260-102-15) / 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": "278d0147-c5b0-4d85-80f5-500ec567feed", "openfda": {"unii": ["04JA59TNSJ"], "rxcui": ["1234579"], "spl_set_id": ["dcd09e27-93ec-463f-8062-a7dad96c4d0f"], "manufacturer_name": ["Bausch & Lomb Americas Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (82260-102-10)  / 10 mL in 1 BOTTLE, DROPPER", "package_ndc": "82260-102-10", "marketing_start_date": "20230331"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (82260-102-15)  / 15 mL in 1 BOTTLE, DROPPER", "package_ndc": "82260-102-15", "marketing_start_date": "20230331"}], "brand_name": "Phenylephrine Hydrochloride", "product_id": "82260-102_278d0147-c5b0-4d85-80f5-500ec567feed", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "82260-102", "generic_name": "phenylephrine hydrochloride", "labeler_name": "Bausch & Lomb Americas Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Phenylephrine Hydrochloride", "active_ingredients": [{"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "25 mg/mL"}], "application_number": "NDA203510", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20230331", "listing_expiration_date": "20261231"}