NDC 0363-0076

Guaifenesin and Dextromethorphan Hydrobromide

Guaifenesin And Dextromethorphan Hydrobromide

Guaifenesin and Dextromethorphan Hydrobromide is a Oral Tablet, Extended Release in the Human Otc Drug category. It is labeled and distributed by Walgreens. The primary component is Guaifenesin; Dextromethorphan Hydrobromide.

Product ID0363-0076_13c678cf-bd1a-4f8f-84ec-274767c7d95b
NDC0363-0076
Product TypeHuman Otc Drug
Proprietary NameGuaifenesin and Dextromethorphan Hydrobromide
Generic NameGuaifenesin And Dextromethorphan Hydrobromide
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2017-09-05
Marketing CategoryNDA / NDA
Application NumberNDA021620
Labeler Namewalgreens
Substance NameGUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Active Ingredient Strength1200 mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0363-0076-28

2 BLISTER PACK in 1 CARTON (0363-0076-28) > 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Start Date2017-09-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0363-0076-14 [00363007614]

Guaifenesin and Dextromethorphan Hydrobromide TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA021620
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-09-05

NDC 0363-0076-28 [00363007628]

Guaifenesin and Dextromethorphan Hydrobromide TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA021620
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-09-05

Drug Details

Active Ingredients

IngredientStrength
GUAIFENESIN1200 mg/1

OpenFDA Data

SPL SET ID:3d0c04a8-9756-4555-b24c-53f074a4f4ff
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1099074

    • NDC Crossover Matching brand name "Guaifenesin and Dextromethorphan Hydrobromide" or generic name "Guaifenesin And Dextromethorphan Hydrobromide"

    NDCBrand NameGeneric Name
    0363-0076Guaifenesin and Dextromethorphan HydrobromideGuaifenesin and Dextromethorphan Hydrobromide
    11822-7156Guaifenesin and Dextromethorphan HydrobromideGuaifenesin and Dextromethorphan Hydrobromide
    24451-133Guaifenesin and Dextromethorphan HydrobromideGuaifenesin and Dextromethorphan Hydrobromide
    24689-123Guaifenesin and Dextromethorphan HydrobromideGuaifenesin and Dextromethorphan Hydrobromide tablet
    30142-706Guaifenesin and Dextromethorphan HydrobromideGuaifenesin and Dextromethorphan Hydrobromide
    49035-077Guaifenesin and Dextromethorphan HydrobromideGuaifenesin and Dextromethorphan Hydrobromide
    68196-073Guaifenesin and Dextromethorphan HydrobromideGuaifenesin and Dextromethorphan Hydrobromide
    51660-073Guaifenesin and Dextromethorphan HydrobromideGuaifenesin and Dextromethorphan Hydrobromide
    58657-505Guaifenesin and Dextromethorphan HydrobromideGuaifenesin and Dextromethorphan Hydrobromide
    62732-9009Guaifenesin and Dextromethorphan HydrobromideGuaifenesin and Dextromethorphan Hydrobromide
    63868-391Guaifenesin and Dextromethorphan HydrobromideGuaifenesin and Dextromethorphan Hydrobromide
    51660-054Guaifenesin and Dextromethorphan HydrobromideGuaifenesin and Dextromethorphan Hydrobromide
    63629-1155Guaifenesin and Dextromethorphan HydrobromideGuaifenesin and Dextromethorphan Hydrobromide
    0536-0970Extra action CoughGuaifenesin and DEXTROMETHORPHAN HYDROBROMIDE
    48433-221GUAIFENESIN AND DEXTROMETHORPHAN HBrguaifenesin and dextromethorphan hydrobromide
    11822-9996Guaifenesin and Dextromethorphan Hydrobromide HBRguaifenesin and dextromethorphan hydrobromide
    43063-801Guaifenesin DMGuaifenesin and Dextromethorphan Hydrobromide
    17856-0056Mucinex DMGuaifenesin and Dextromethorphan Hydrobromide
    50090-1077Mucinex DMGuaifenesin and Dextromethorphan Hydrobromide
    50090-1078Mucinex DMGuaifenesin and Dextromethorphan Hydrobromide
    50090-2298Mucinex DMGuaifenesin and Dextromethorphan Hydrobromide
    0363-9013MUCUS RELIEF DMGUAIFENESIN and DEXTROMETHORPHAN HYDROBROMIDE
    0363-9891MUCUS RELIEF DMGUAIFENESIN and DEXTROMETHORPHAN HYDROBROMIDE
    0363-9897MUCUS RELIEF DMGUAIFENESIN and DEXTROMETHORPHAN HYDROBROMIDE
    30142-991Mucus Relief ER DMGuaifenesin and Dextromethorphan Hydrobromide
    0904-0053Rabofen DMGuaifenesin and Dextromethorphan Hydrobromide
    0904-6306Robafen DM Cough Sugar Free ClearGuaifenesin and Dextromethorphan Hydrobromide
    17856-6306Robafen DM Cough Sugar Free ClearGuaifenesin and Dextromethorphan Hydrobromide
    17856-0134Siltussin DM DAS Cough FormulaGuaifenesin and Dextromethorphan Hydrobromide
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.