NDC 21695-698

Promethazine Hydrochloride and Dextromethorphan Hydrobromide

Promethazine Hydrochloride And Dextromethorphan Hydrobromide

Promethazine Hydrochloride and Dextromethorphan Hydrobromide is a Oral Syrup in the Human Prescription Drug category. It is labeled and distributed by Rebel Distributors Corp. The primary component is Dextromethorphan Hydrobromide; Promethazine Hydrochloride.

• Product ID: 21695-698_56dfd62c-d386-4e9f-9946-07eda94fa122
• NDC: 21695-698
• Product Type: Human Prescription Drug
• Proprietary Name: Promethazine Hydrochloride and Dextromethorphan Hydrobromide
• Generic Name: Promethazine Hydrochloride And Dextromethorphan Hydrobromide
• Dosage Form: Syrup
• Route of Administration: ORAL
• Marketing Start Date: 1985-01-04
• Marketing Category: ANDA / ANDA
• Application Number: ANDA088864
• Labeler Name: Rebel Distributors Corp
• Substance Name: DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE
• Active Ingredient Strength: 15 mg/5mL; mg/5mL
• Pharm Classes: Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA],Phenothiazine [EPC],Phenothiazines [CS]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 21695-698-04

118 mL in 1 BOTTLE (21695-698-04)

• Marketing Start Date: 1985-01-04
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 21695-698-04 [21695069804]

Promethazine Hydrochloride and Dextromethorphan Hydrobromide SYRUP

• Marketing Category: ANDA
• Application Number: ANDA088864
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1985-01-04
• Inactivation Date: 2019-09-24

Drug Details

Active Ingredients

Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	15 mg/5mL

OpenFDA Data

• SPL SET ID: 56dfd62c-d386-4e9f-9946-07eda94fa122
• Manufacturer:
  • Rebel Distributors Corp
• UNII:
  • 9D2RTI9KYH
  • R61ZEH7I1I
• RxNorm Concept Unique ID - RxCUI:
  • 991528

Pharmacological Class

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

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