NDC 65162-680

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 Amneal Pharmaceuticals Llc. The primary component is Promethazine Hydrochloride; Dextromethorphan Hydrobromide.

• Product ID: 65162-680_1d957621-f491-4954-b0f9-fc2967699a0f
• NDC: 65162-680
• 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: 2011-03-04
• Marketing Category: ANDA / ANDA
• Application Number: ANDA090575
• Labeler Name: Amneal Pharmaceuticals LLC
• Substance Name: PROMETHAZINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
• Active Ingredient Strength: 6 mg/5mL; mg/5mL
• Pharm Classes: Phenothiazine [EPC],Phenothiazines [CS],Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 65162-680-86

118 mL in 1 BOTTLE (65162-680-86)

• Marketing Start Date: 2011-03-04
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 65162-680-86 [65162068086]

Promethazine Hydrochloride and Dextromethorphan Hydrobromide SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA090575
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2011-03-04

NDC 65162-680-90 [65162068090]

Promethazine Hydrochloride and Dextromethorphan Hydrobromide SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA090575
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2011-03-04

Drug Details

Active Ingredients

Ingredient	Strength
PROMETHAZINE HYDROCHLORIDE	6.25 mg/5mL

Pharmacological Class

• Phenothiazine [EPC]
• Phenothiazines [CS]
• Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]
• Sigma-1 Agonist [EPC]
• Uncompetitive NMDA Receptor Antagonists [MoA]
• Sigma-1 Receptor Agonists [MoA]

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