phenylephrine hydrochloride

Generic: phenylephrine hydrochloride

Labeler: paragon bioteck, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name phenylephrine hydrochloride
Generic Name phenylephrine hydrochloride
Labeler paragon bioteck, inc.
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

phenylephrine hydrochloride 100 mg/mL

Manufacturer
Paragon BioTeck, Inc.

Identifiers & Regulatory

Product NDC 42702-103
Product ID 42702-103_ff463c02-5533-c9ad-e053-6294a90a7035
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA203510
Listing Expiration 2026-12-31
Marketing Start 2013-04-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42702103
Hyphenated Format 42702-103

Supplemental Identifiers

RxCUI
1234571 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
  • 100 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (42702-103-05) / 5 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

42702-103-05 1 BOTTLE, DROPPER in 1 CARTON (42702-103-05) / 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": "ff463c02-5533-c9ad-e053-6294a90a7035", "openfda": {"unii": ["04JA59TNSJ"], "rxcui": ["1234571", "1234579"], "spl_set_id": ["a4d3fe20-f063-11e0-ac29-0002a5d5c51b"], "manufacturer_name": ["Paragon BioTeck, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (42702-103-05)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "42702-103-05", "marketing_start_date": "20130415"}], "brand_name": "Phenylephrine Hydrochloride", "product_id": "42702-103_ff463c02-5533-c9ad-e053-6294a90a7035", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "42702-103", "generic_name": "phenylephrine hydrochloride", "labeler_name": "Paragon BioTeck, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Phenylephrine Hydrochloride", "active_ingredients": [{"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "100 mg/mL"}], "application_number": "NDA203510", "marketing_category": "NDA", "marketing_start_date": "20130415", "listing_expiration_date": "20261231"}