NDC 16103-389

PHARBINEX-PE

Guaifenesin 400mg And Phenylephrine Hcl 10mg

PHARBINEX-PE is a Oral Tablet, Coated in the Human Otc Drug category. It is labeled and distributed by Pharbest Pharmaceuticals, Inc.. The primary component is Guaifenesin; Phenylephrine Hydrochloride.

• Product ID: 16103-389_0615f444-f14a-426f-975a-822f67e0a79f
• NDC: 16103-389
• Product Type: Human Otc Drug
• Proprietary Name: PHARBINEX-PE
• Generic Name: Guaifenesin 400mg And Phenylephrine Hcl 10mg
• Dosage Form: Tablet, Coated
• Route of Administration: ORAL
• Marketing Start Date: 2018-05-01
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Pharbest Pharmaceuticals, Inc.
• Substance Name: GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 400 mg/1; mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 16103-389-04

1 BOTTLE, PLASTIC in 1 CARTON (16103-389-04) > 30 TABLET, COATED in 1 BOTTLE, PLASTIC

• Marketing Start Date: 2018-05-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 16103-389-04 [16103038904]

PHARBINEX-PE TABLET, COATED

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2018-05-01

Drug Details

Active Ingredients

Ingredient	Strength
GUAIFENESIN	400 mg/1

OpenFDA Data

• SPL SET ID: cad73d08-a439-446f-aaa9-d1fd18ec1e54
• Manufacturer:
  • Pharbest Pharmaceuticals, Inc.
• UNII:
  • 04JA59TNSJ
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 1304111
• UPC Code:
  • 0016103389041

NDC Crossover Matching brand name "PHARBINEX-PE" or generic name "Guaifenesin 400mg And Phenylephrine Hcl 10mg"

NDC	Brand Name	Generic Name
16103-389	PHARBINEX-PE	GUAIFENESIN 400mg and PHENYLEPHRINE HCL 10MG
73057-389	Pharbinex-PE	GUAIFENESIN 400mg and PHENYLEPHRINE HCL 10MG