NDC 17856-0604

Dextromethorphan Hydrobromide and Promethazine Hydrochloride

Dextromethorphan Hydrobromide And Promethazine Hydrochloride

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

• Product ID: 17856-0604_bdc594a6-ff16-4cf7-bcc8-119738fd7edd
• NDC: 17856-0604
• Product Type: Human Prescription Drug
• Proprietary Name: Dextromethorphan Hydrobromide and Promethazine Hydrochloride
• Generic Name: Dextromethorphan Hydrobromide And Promethazine Hydrochloride
• Dosage Form: Syrup
• Route of Administration: ORAL
• Marketing Start Date: 1985-01-04
• Marketing Category: ANDA / ANDA
• Application Number: ANDA088864
• Labeler Name: ATLANTIC BIOLOGICALS CORP.
• 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 17856-0604-4

72 CUP in 1 BOX (17856-0604-4) > 5 mL in 1 CUP (17856-0604-5)

• Marketing Start Date: 2022-06-08
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 17856-0604-5 [17856060405]

Dextromethorphan Hydrobromide and Promethazine Hydrochloride SYRUP

• Marketing Category: ANDA
• Application Number: ANDA088864
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1985-01-04
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	15 mg/5mL

OpenFDA Data

• SPL SET ID: ba7ad7f8-3261-4977-a13a-f6e07c510a9a
• Manufacturer:
  • Atlantic Biologicals Corps
• 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 "Dextromethorphan Hydrobromide and Promethazine Hydrochloride" or generic name "Dextromethorphan Hydrobromide And Promethazine Hydrochloride"

NDC	Brand Name	Generic Name
17856-0604	Dextromethorphan Hydrobromide and Promethazine Hydrochloride	Dextromethorphan Hydrobromide and Promethazine Hydrochloride
63187-355	Dextromethorphan Hydrobromide and Promethazine Hydrochloride	Dextromethorphan Hydrobromide and Promethazine Hydrochloride
0603-1586	PROMETHAZINE DM	Dextromethorphan Hydrobromide and Promethazine Hydrochloride
17856-1586	PROMETHAZINE DM	Dextromethorphan Hydrobromide and Promethazine Hydrochloride
33261-732	PROMETHAZINE DM	Dextromethorphan Hydrobromide and Promethazine Hydrochloride
50090-0225	PROMETHAZINE DM	Dextromethorphan Hydrobromide and Promethazine Hydrochloride
50090-4125	PROMETHAZINE DM	Dextromethorphan Hydrobromide and Promethazine Hydrochloride
50436-1867	PROMETHAZINE DM	Dextromethorphan Hydrobromide and Promethazine Hydrochloride
53002-4260	PROMETHAZINE DM	Dextromethorphan Hydrobromide and Promethazine Hydrochloride
63187-272	PROMETHAZINE DM	Dextromethorphan Hydrobromide and Promethazine Hydrochloride
68071-1643	PROMETHAZINE DM	Dextromethorphan Hydrobromide and Promethazine Hydrochloride
68788-9097	PROMETHAZINE DM	Dextromethorphan Hydrobromide and Promethazine Hydrochloride
70518-0418	PROMETHAZINE DM	Dextromethorphan Hydrobromide and Promethazine Hydrochloride