Package 64950-345-16

Brand: promethazine hydrochloride and phenylephrine hydrochloride

Generic: promethazine hydrochloride and phenylephrine hydrochloride
NDC Package

Package Facts

Identity

Package NDC 64950-345-16
Digits Only 6495034516
Product NDC 64950-345
Description

473 mL in 1 BOTTLE, PLASTIC (64950-345-16)

Marketing

Marketing Status
Marketed Since 2024-07-15
Brand promethazine hydrochloride and phenylephrine hydrochloride
Generic promethazine hydrochloride and phenylephrine hydrochloride
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "df5aecd4-2175-4495-b6cc-13d69e718d09", "openfda": {"unii": ["04JA59TNSJ", "R61ZEH7I1I"], "rxcui": ["1248057"], "spl_set_id": ["7f8ebc9c-c4e6-4344-95a5-ec25b8c99bc1"], "manufacturer_name": ["Genus Lifesciences Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE, PLASTIC (64950-345-16)", "package_ndc": "64950-345-16", "marketing_start_date": "20240715"}], "brand_name": "Promethazine Hydrochloride and Phenylephrine Hydrochloride", "product_id": "64950-345_df5aecd4-2175-4495-b6cc-13d69e718d09", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Phenothiazine [EPC]", "Phenothiazines [CS]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "64950-345", "generic_name": "promethazine hydrochloride and phenylephrine hydrochloride", "labeler_name": "Genus Lifesciences Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Promethazine Hydrochloride and Phenylephrine Hydrochloride", "active_ingredients": [{"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/5mL"}, {"name": "PROMETHAZINE HYDROCHLORIDE", "strength": "6.25 mg/5mL"}], "application_number": "ANDA040654", "marketing_category": "ANDA", "marketing_start_date": "20240715", "listing_expiration_date": "20261231"}