NDC 28595-780

HistaFlex

Acetaminophen And Pyrilamine Maleate

HistaFlex is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Allegis Pharmaceuticals, Llc. The primary component is Acetaminophen; Pyrilamine Maleate.

• Product ID: 28595-780_52cf1494-9ab8-4ed1-9061-5d192c204846
• NDC: 28595-780
• Product Type: Human Otc Drug
• Proprietary Name: HistaFlex
• Generic Name: Acetaminophen And Pyrilamine Maleate
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2014-05-22
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part343
• Labeler Name: Allegis Pharmaceuticals, LLC
• Substance Name: ACETAMINOPHEN; PYRILAMINE MALEATE
• Active Ingredient Strength: 325 mg/1; mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 28595-780-01

100 TABLET in 1 BOTTLE (28595-780-01)

• Marketing Start Date: 2014-05-22
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 28595-780-01 [28595078001]

HistaFlex TABLET

• Marketing Category: OTC MONOGRAPH NOT FINAL
• Application Number: part343
• Product Type: HUMAN OTC DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-05-22
• Marketing End Date: 2019-12-31

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	325 mg/1

OpenFDA Data

• SPL SET ID: b811e4f6-7cd0-403c-a44c-7c6c6787c15d
• Manufacturer:
  • Allegis Pharmaceuticals, LLC
• UNII:
  • 362O9ITL9D
  • R35D29L3ZA
• RxNorm Concept Unique ID - RxCUI:
  • 1538456
• UPC Code:
  • 0328595780016