NDC 73057-389

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 Ulai Health Llc. The primary component is Guaifenesin; Phenylephrine Hydrochloride.

• Product ID: 73057-389_2a1863f7-a7f6-40e2-ab03-73654c9a6a1e
• NDC: 73057-389
• 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: 2019-07-18
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Ulai Health LLC
• 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 73057-389-04

30 TABLET, COATED in 1 BOTTLE, PLASTIC (73057-389-04)

• Marketing Start Date: 2019-07-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 73057-389-04 [73057038904]

Pharbinex-PE TABLET, COATED

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2019-07-18

Drug Details

Active Ingredients

Ingredient	Strength
GUAIFENESIN	400 mg/1

OpenFDA Data

• SPL SET ID: e459bb83-b1d6-42fc-aa46-99ad117e6144
• Manufacturer:
  • Ulai Health LLC
• UNII:
  • 04JA59TNSJ
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 1304111
• UPC Code:
  • 0373057389047

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