NDC 50436-0433

dextromethorphan polistirex extended release

Dextromethorphan Polistirex

dextromethorphan polistirex extended release is a Oral Suspension in the Human Otc Drug category. It is labeled and distributed by Unit Dose Services. The primary component is Dextromethorphan Hydrobromide.

• Product ID: 50436-0433_de7deea7-e574-4b93-ba10-65a446e7f2ff
• NDC: 50436-0433
• Product Type: Human Otc Drug
• Proprietary Name: dextromethorphan polistirex extended release
• Generic Name: Dextromethorphan Polistirex
• Dosage Form: Suspension
• Route of Administration: ORAL
• Marketing Start Date: 2012-09-10
• Marketing Category: ANDA / ANDA
• Application Number: ANDA091135
• Labeler Name: Unit Dose Services
• Substance Name: DEXTROMETHORPHAN HYDROBROMIDE
• Active Ingredient Strength: 30 mg/5mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 50436-0433-1

1 BOTTLE in 1 CARTON (50436-0433-1) > 89 mL in 1 BOTTLE

• Marketing Start Date: 2017-07-13
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50436-0433-1 [50436043301]

dextromethorphan polistirex extended release SUSPENSION

• Marketing Category: ANDA
• Application Number: ANDA091135
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2017-07-13

Drug Details

Active Ingredients

Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	30 mg/5mL

OpenFDA Data

• SPL SET ID: 8007a226-f0d2-4618-af13-33c807f36ab5
• Manufacturer:
  • Unit Dose Services
• UNII:
  • 9D2RTI9KYH
• RxNorm Concept Unique ID - RxCUI:
  • 1373045

NDC Crossover Matching brand name "dextromethorphan polistirex extended release" or generic name "Dextromethorphan Polistirex"

NDC	Brand Name	Generic Name
45802-433	dextromethorphan polistirex extended release	dextromethorphan polistirex extended release
50436-0433	dextromethorphan polistirex extended release	dextromethorphan polistirex extended release
0113-7384	basic care cough DM	dextromethorphan polistirex
0363-0899	childrens cough dm	Dextromethorphan polistirex
0031-8725	Childrens Robitussin 12 Hour Cough Relief	dextromethorphan polistirex
0031-8726	Childrens Robitussin 12 Hour Cough Relief	dextromethorphan polistirex
0363-0384	Cough DM	dextromethorphan polistirex
0363-0494	Cough DM	dextromethorphan polistirex
0363-0958	Cough DM	dextromethorphan polistirex
0904-6312	cough dm	dextromethorphan polistirex
11822-0384	Cough DM	dextromethorphan polistirex
11822-0494	Cough DM	dextromethorphan polistirex
0113-0384	good sense cough dm	dextromethorphan polistirex
0113-0958	Good Sense Cough DM	dextromethorphan polistirex
0031-8655	Robitussin 12 Hour Cough Relief	dextromethorphan polistirex
0031-8753	Robitussin 12 Hour Cough Relief	dextromethorphan polistirex
0031-8754	Robitussin 12 Hour Cough Relief	dextromethorphan polistirex
0031-8755	Robitussin 12 Hour Cough Relief	dextromethorphan polistirex
11673-114	up and up 12 hour cough relief	dextromethorphan polistirex