Package 64950-345-16
Brand: promethazine hydrochloride and phenylephrine hydrochloride
Generic: promethazine hydrochloride and phenylephrine hydrochloridePackage 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
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"}