phenylephrine hydrochloride

Generic: phenylephrine hydrochloride

Labeler: lifestar pharma llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

phenylephrine hydrochloride 25 mg/mL

Manufacturer
Lifestar Pharma LLC

Identifiers & Regulatory

Product NDC 70756-649
Product ID 70756-649_b19ab20c-5138-461a-adff-c5173046256c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216859
Listing Expiration 2026-12-31
Marketing Start 2023-03-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70756649
Hyphenated Format 70756-649

Supplemental Identifiers

RxCUI
1234579
UPC
0370756649359 0370756629252 0370756676300
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 (70756-649-35) / 15 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

70756-649-35 1 BOTTLE, DROPPER in 1 CARTON (70756-649-35) / 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": "b19ab20c-5138-461a-adff-c5173046256c", "openfda": {"upc": ["0370756649359", "0370756629252", "0370756676300"], "unii": ["04JA59TNSJ"], "rxcui": ["1234579"], "spl_set_id": ["f43e4abd-0083-4fe5-9c27-0ba9245e5138"], "manufacturer_name": ["Lifestar Pharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (70756-649-35)  / 15 mL in 1 BOTTLE, DROPPER", "package_ndc": "70756-649-35", "marketing_start_date": "20230315"}], "brand_name": "Phenylephrine Hydrochloride", "product_id": "70756-649_b19ab20c-5138-461a-adff-c5173046256c", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "70756-649", "generic_name": "Phenylephrine Hydrochloride", "labeler_name": "Lifestar Pharma LLC", "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": "20230315", "listing_expiration_date": "20261231"}