phenylephrine hydrochloride

Generic: phenylephrine hydrochloride

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

phenylephrine hydrochloride 25 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-680
Product ID 68083-680_b31e3905-8ee4-46db-ba72-358ea7d44f10
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218129
Listing Expiration 2026-12-31
Marketing Start 2025-09-17

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083680
Hyphenated Format 68083-680

Supplemental Identifiers

RxCUI
1234571 1234579
UPC
0368083680015
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 ANDA218129 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 25 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (68083-680-01) / 15 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

68083-680-01 1 BOTTLE, DROPPER in 1 CARTON (68083-680-01) / 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": "b31e3905-8ee4-46db-ba72-358ea7d44f10", "openfda": {"upc": ["0368083680015"], "unii": ["04JA59TNSJ"], "rxcui": ["1234571", "1234579"], "spl_set_id": ["2ba80bb2-24f3-4bce-bc04-a6ff4c54fefb"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (68083-680-01)  / 15 mL in 1 BOTTLE, DROPPER", "package_ndc": "68083-680-01", "marketing_start_date": "20250917"}], "brand_name": "PHENYLEPHRINE HYDROCHLORIDE", "product_id": "68083-680_b31e3905-8ee4-46db-ba72-358ea7d44f10", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "68083-680", "generic_name": "PHENYLEPHRINE HYDROCHLORIDE", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PHENYLEPHRINE HYDROCHLORIDE", "active_ingredients": [{"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "25 mg/mL"}], "application_number": "ANDA218129", "marketing_category": "ANDA", "marketing_start_date": "20250917", "listing_expiration_date": "20261231"}