phenylephrine hydrochloride

Generic: phenylephrine hydrochloride

Labeler: caplin steriles limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name phenylephrine hydrochloride
Generic Name phenylephrine hydrochloride
Labeler caplin steriles limited
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

phenylephrine hydrochloride 100 mg/mL

Manufacturer
Caplin Steriles Limited

Identifiers & Regulatory

Product NDC 65145-150
Product ID 65145-150_606202d3-4976-427a-8ced-f8ae0c2a9a4c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215183
Listing Expiration 2026-12-31
Marketing Start 2025-01-23

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65145150
Hyphenated Format 65145-150

Supplemental Identifiers

RxCUI
1234571 1234579
UPC
0365145148018 0365145150011 0365145149015
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
  • 100 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (65145-150-01) / 5 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

65145-150-01 1 BOTTLE, DROPPER in 1 CARTON (65145-150-01) / 5 mL in 1 BOTTLE, DROPPER

Ingredients (1)

phenylephrine hydrochloride (100 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": "606202d3-4976-427a-8ced-f8ae0c2a9a4c", "openfda": {"upc": ["0365145148018", "0365145150011", "0365145149015"], "unii": ["04JA59TNSJ"], "rxcui": ["1234571", "1234579"], "spl_set_id": ["1b3eec91-5be5-4010-bf92-4c3e72b39b2a"], "manufacturer_name": ["Caplin Steriles Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (65145-150-01)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "65145-150-01", "marketing_start_date": "20250123"}], "brand_name": "PHENYLEPHRINE HYDROCHLORIDE", "product_id": "65145-150_606202d3-4976-427a-8ced-f8ae0c2a9a4c", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "65145-150", "generic_name": "phenylephrine hydrochloride", "labeler_name": "Caplin Steriles Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PHENYLEPHRINE HYDROCHLORIDE", "active_ingredients": [{"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "100 mg/mL"}], "application_number": "ANDA215183", "marketing_category": "ANDA", "marketing_start_date": "20250123", "listing_expiration_date": "20261231"}