NDC 52083-482

Dologen 325

Acetaminophen, Dexbrompheniramine

Dologen 325 is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Kramer Novis. The primary component is Acetaminophen; Dexbrompheniramine Maleate.

Product ID52083-482_4c06d309-d461-4ddc-8e56-905cf356bd02
NDC52083-482
Product TypeHuman Otc Drug
Proprietary NameDologen 325
Generic NameAcetaminophen, Dexbrompheniramine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2014-08-27
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameKramer Novis
Substance NameACETAMINOPHEN; DEXBROMPHENIRAMINE MALEATE
Active Ingredient Strength325 mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 52083-482-02

2 TABLET in 1 PACKET (52083-482-02)
Marketing Start Date2014-08-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52083-482-02 [52083048202]

Dologen 325 TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-08-27

NDC 52083-482-90 [52083048290]

Dologen 325 TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2014-08-27

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN325 mg/1

OpenFDA Data

SPL SET ID:dad63da3-cd1f-42a8-93d5-44b39aae1268
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1546700
  • 1546702
  • UPC Code
  • 0352083482908

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