Package 68788-8100-1
Brand: promethazine hydrochloride and dextromethorphan hydrobromide oral solution
Generic: promethazine hydrochloride and dextromethorphan hydrobromide oral solutionPackage Facts
Identity
Package NDC
68788-8100-1
Digits Only
6878881001
Product NDC
68788-8100
Description
118 mL in 1 BOTTLE (68788-8100-1)
Marketing
Marketing Status
Brand
promethazine hydrochloride and dextromethorphan hydrobromide oral solution
Generic
promethazine hydrochloride and dextromethorphan hydrobromide oral solution
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "259ec19b-1e8f-4e74-b923-9b746db17f8f", "openfda": {"unii": ["9D2RTI9KYH", "R61ZEH7I1I"], "rxcui": ["991528"], "spl_set_id": ["88137097-16b3-44b7-8e1f-26a8242d8179"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE (68788-8100-1)", "package_ndc": "68788-8100-1", "marketing_start_date": "20211008"}], "brand_name": "Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution", "product_id": "68788-8100_259ec19b-1e8f-4e74-b923-9b746db17f8f", "dosage_form": "SOLUTION", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]", "Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]"], "product_ndc": "68788-8100", "generic_name": "Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "15 mg/5mL"}, {"name": "PROMETHAZINE HYDROCHLORIDE", "strength": "6.25 mg/5mL"}], "application_number": "ANDA040649", "marketing_category": "ANDA", "marketing_start_date": "20211008", "listing_expiration_date": "20261231"}