NDC 16103-381

PHARBINEX-DM

Guaifenesin 400mg And Dextromethorphan Hbr 20mg

PHARBINEX-DM is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Pharbest Pharmaceuticals, Inc.. The primary component is Guaifenesin; Dextromethorphan Hydrobromide.

• Product ID: 16103-381_7cf187b4-776b-4cc5-8416-9757210cb423
• NDC: 16103-381
• Product Type: Human Otc Drug
• Proprietary Name: PHARBINEX-DM
• Generic Name: Guaifenesin 400mg And Dextromethorphan Hbr 20mg
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2018-04-02
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Pharbest Pharmaceuticals, Inc.
• Substance Name: GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
• Active Ingredient Strength: 400 mg/1; mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 16103-381-04

1 BOTTLE, PLASTIC in 1 CARTON (16103-381-04) > 30 TABLET in 1 BOTTLE, PLASTIC

• Marketing Start Date: 2018-04-02
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 16103-381-04 [16103038104]

PHARBINEX-DM TABLET

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2018-04-02

Drug Details

Active Ingredients

Ingredient	Strength
GUAIFENESIN	400 mg/1

OpenFDA Data

• SPL SET ID: 8d71db43-da87-45ee-aa4a-7e870bc5016d
• Manufacturer:
  • Pharbest Pharmaceuticals, Inc.
• UNII:
  • 9D2RTI9KYH
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 1147685
• UPC Code:
  • 0016103381045

NDC Crossover Matching brand name "PHARBINEX-DM" or generic name "Guaifenesin 400mg And Dextromethorphan Hbr 20mg"

NDC	Brand Name	Generic Name
16103-381	PHARBINEX-DM	GUAIFENESIN 400mg and DEXTROMETHORPHAN HBR 20MG
73057-381	Pharbinex-DM	Guaifenesin 400mg and Dextromethorphan HBr 20mg