NDC 27808-057

Promethazine Hydrochloride and Dextromethorphan Hydrobromide

Promethazine Hydrochloride And Dextromethorphan Hydrobromide

Promethazine Hydrochloride and Dextromethorphan Hydrobromide is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Tris Pharma Inc. The primary component is Dextromethorphan Hydrobromide; Promethazine Hydrochloride.

• Product ID: 27808-057_4c07a6e7-ee16-4182-a23d-81842ddec48c
• NDC: 27808-057
• Product Type: Human Prescription Drug
• Proprietary Name: Promethazine Hydrochloride and Dextromethorphan Hydrobromide
• Generic Name: Promethazine Hydrochloride And Dextromethorphan Hydrobromide
• Dosage Form: Solution
• Route of Administration: ORAL
• Marketing Start Date: 2014-01-31
• Marketing Category: ANDA /
• Application Number: ANDA091687
• Labeler Name: Tris Pharma Inc
• Substance Name: DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE
• Active Ingredient Strength: 15 mg/5mL; mg/5mL
• Pharm Classes: 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]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 27808-057-01

473 mL in 1 BOTTLE, PLASTIC (27808-057-01)

• Marketing Start Date: 2021-11-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 27808-057-01 [27808005701]

Promethazine Hydrochloride and Dextromethorphan Hydrobromide SYRUP

• Marketing Category: ANDA
• Application Number: ANDA091687
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-01-31
• Marketing End Date: 2016-11-17

Drug Details

NDC Crossover Matching brand name "Promethazine Hydrochloride and Dextromethorphan Hydrobromide" or generic name "Promethazine Hydrochloride And Dextromethorphan Hydrobromide"

NDC	Brand Name	Generic Name
21695-698	Promethazine Hydrochloride and Dextromethorphan Hydrobromide	Promethazine Hydrochloride and Dextromethorphan Hydrobromide
27808-057	Promethazine Hydrochloride and Dextromethorphan Hydrobromide	Promethazine Hydrochloride and Dextromethorphan Hydrobromide
50090-4934	Promethazine Hydrochloride and Dextromethorphan Hydrobromide	promethazine hydrochloride and dextromethorphan hydrobromide
60432-604	Promethazine Hydrochloride and Dextromethorphan Hydrobromide	promethazine hydrochloride and dextromethorphan hydrobromide
65162-680	Promethazine Hydrochloride and Dextromethorphan Hydrobromide	Promethazine Hydrochloride and Dextromethorphan Hydrobromide