NDC 60432-604

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 Morton Grove Pharmaceuticals, Inc.. The primary component is Dextromethorphan Hydrobromide; Promethazine Hydrochloride.

• Product ID: 60432-604_1b7f66c8-f541-4ed5-a38d-0cd32ce62cd4
• NDC: 60432-604
• 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: Morton Grove Pharmaceuticals, Inc.
• 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: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 60432-604-16

473 mL in 1 BOTTLE, PLASTIC (60432-604-16)

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

NDC SPL Data Element Entries

NDC 60432-604-16 [60432060416]

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

NDC 60432-604-04 [60432060404]

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
• Marketing End Date: 2017-07-25

Drug Details

Active Ingredients

Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	15 mg/5mL

OpenFDA Data

• SPL SET ID: 620478d3-aee5-488e-a337-3ad197ede6b6
• Manufacturer:
  • Morton Grove Pharmaceuticals, Inc.
• 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]

Medicade Reported Pricing

60432060416 PROMETHAZINE-DM SYRUP

Pricing Unit: ML | Drug Type:

60432060404 PROMETHAZINE-DM SYRUP

Pricing Unit: ML | Drug Type:

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