phenylephrine hydrochloride

Generic: phenylephrine hydrochloride

Labeler: northstar rxllc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name phenylephrine hydrochloride
Generic Name phenylephrine hydrochloride
Labeler northstar rxllc
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

phenylephrine hydrochloride 25 mg/mL

Manufacturer
NorthStar RxLLC

Identifiers & Regulatory

Product NDC 72603-520
Product ID 72603-520_e31ea9e0-264f-451a-84f7-578d3445e2dd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216859
Listing Expiration 2026-12-31
Marketing Start 2024-10-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72603520
Hyphenated Format 72603-520

Supplemental Identifiers

RxCUI
1234579
UPC
0372603520019 0372603520026
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 ANDA216859 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 25 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (72603-520-01) / 2 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (72603-520-02) / 15 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (2)

72603-520-01 1 BOTTLE, DROPPER in 1 CARTON (72603-520-01) / 2 mL in 1 BOTTLE, DROPPER 72603-520-02 1 BOTTLE, DROPPER in 1 CARTON (72603-520-02) / 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": "e31ea9e0-264f-451a-84f7-578d3445e2dd", "openfda": {"upc": ["0372603520019", "0372603520026"], "unii": ["04JA59TNSJ"], "rxcui": ["1234579"], "spl_set_id": ["3ce681eb-8580-49bf-962a-68a576fddd57"], "manufacturer_name": ["NorthStar RxLLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (72603-520-01)  / 2 mL in 1 BOTTLE, DROPPER", "package_ndc": "72603-520-01", "marketing_start_date": "20241001"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (72603-520-02)  / 15 mL in 1 BOTTLE, DROPPER", "package_ndc": "72603-520-02", "marketing_start_date": "20241001"}], "brand_name": "Phenylephrine Hydrochloride", "product_id": "72603-520_e31ea9e0-264f-451a-84f7-578d3445e2dd", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "72603-520", "generic_name": "Phenylephrine Hydrochloride", "labeler_name": "NorthStar RxLLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Phenylephrine Hydrochloride", "active_ingredients": [{"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "25 mg/mL"}], "application_number": "ANDA216859", "marketing_category": "ANDA", "marketing_start_date": "20241001", "listing_expiration_date": "20261231"}