NDC 53345-011

Dextromethorphan HBr 15 mg

Dextromethorphan Hbr

Dextromethorphan HBr 15 mg is a Oral Capsule, Liquid Filled in the Human Otc Drug category. It is labeled and distributed by Humanwell Puracap Pharmaceutical (wuhan), Ltd.. The primary component is Dextromethorphan Hydrobromide.

• Product ID: 53345-011_85aaafd0-4196-40d7-9c03-9c8131e23a5e
• NDC: 53345-011
• Product Type: Human Otc Drug
• Proprietary Name: Dextromethorphan HBr 15 mg
• Generic Name: Dextromethorphan Hbr
• Dosage Form: Capsule, Liquid Filled
• Route of Administration: ORAL
• Marketing Start Date: 2014-01-30
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.
• Substance Name: DEXTROMETHORPHAN HYDROBROMIDE
• Active Ingredient Strength: 15 mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 53345-011-01

1 BAG in 1 BOX (53345-011-01) > 12000 CAPSULE, LIQUID FILLED in 1 BAG

• Marketing Start Date: 2014-01-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 53345-011-01 [53345001101]

Dextromethorphan HBr 15 mg CAPSULE, LIQUID FILLED

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2014-01-30

Drug Details

Active Ingredients

Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	15 mg/1

OpenFDA Data

• SPL SET ID: 028b025e-2dde-4bef-ba7b-61774e855b4b
• Manufacturer:
  • Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.
• UNII:
  • 9D2RTI9KYH
• RxNorm Concept Unique ID - RxCUI:
  • 1090487

NDC Crossover Matching brand name "Dextromethorphan HBr 15 mg" or generic name "Dextromethorphan Hbr"

NDC	Brand Name	Generic Name
53345-011	Dextromethorphan HBr 15 mg	Dextromethorphan HBr 15 mg
53345-028	Dextromethorphan HBr 15 mg	Dextromethorphan HBr 15 mg
21130-383	Adult Cough Relief DM	Dextromethorphan HBr
0363-0500	Cough	Dextromethorphan HBr
15127-661	Cough Control	Dextromethorphan HBr
0363-8990	Cough Relief	DEXTROMETHORPHAN HBr
15127-309	Cough Relief	Dextromethorphan HBr
24385-262	Cough Relief	Dextromethorphan HBr
24385-263	Cough Relief	Dextromethorphan HBr
33992-0666	Cough Relief	Dextromethorphan HBr
36800-454	Cough Relief	Dextromethorphan HBr
36800-509	Cough Relief	Dextromethorphan HBr
0536-1323	Dextromethorphan HBr	Dextromethorphan HBr
0536-1334	Dextromethorphan HBr 15 mg Liquid Gels	Dextromethorphan HBr
0395-9126	Father Johns Medicine	Dextromethorphan HBr
0536-1068	Robafen Cough	Dextromethorphan HBr
0031-8741	ROBITUSSIN LINGERING COLD LONG-ACTING COUGHGELS	dextromethorphan HBr
21130-635	Signature Care Daytime Cough	Dextromethorphan HBr
0363-6610	Wal-Tussin	Dextromethorphan HBr