NDC 10702-005

Dexbrompherniramine Maleate and Pseudoephedrine Sulfate 6mg/120mg

Dexbrompherniramine Maleate And Pseudoephedrine Sulfate

Dexbrompherniramine Maleate and Pseudoephedrine Sulfate 6mg/120mg is a Oral Tablet, Extended Release in the Human Otc Drug category. It is labeled and distributed by Kvk-tech, Inc.. The primary component is Dexbrompheniramine Maleate; Pseudoephedrine Sulfate.

Product ID10702-005_838e40fd-bd38-4b8d-abd4-45da435f1777
NDC10702-005
Product TypeHuman Otc Drug
Proprietary NameDexbrompherniramine Maleate and Pseudoephedrine Sulfate 6mg/120mg
Generic NameDexbrompherniramine Maleate And Pseudoephedrine Sulfate
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2018-12-17
Marketing CategoryANDA / ANDA
Application NumberANDA078648
Labeler NameKVK-TECH, INC.
Substance NameDEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE
Active Ingredient Strength6 mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 10702-005-03

30 TABLET, EXTENDED RELEASE in 1 BOTTLE (10702-005-03)
Marketing Start Date2018-12-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 10702-005-03 [10702000503]

Dexbrompherniramine Maleate and Pseudoephedrine Sulfate 6mg/120mg TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA078648
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-12-17

NDC 10702-005-21 [10702000521]

Dexbrompherniramine Maleate and Pseudoephedrine Sulfate 6mg/120mg TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA078648
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-12-17

Drug Details

Active Ingredients

IngredientStrength
DEXBROMPHENIRAMINE MALEATE6 mg/1

OpenFDA Data

SPL SET ID:cc1c8c6b-66a4-4d2d-88b2-02ad3591a0f4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1370963
  • UPC Code
  • 0310702005037
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