NDC 63304-110

Guaifenesin and Dextromethorphan HBr

Guaifenesin And Dextromethorphan Hbr

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

Product ID63304-110_801949ca-1baf-4a19-8466-91b4269a2c63
NDC63304-110
Product TypeHuman Otc Drug
Proprietary NameGuaifenesin and Dextromethorphan HBr
Generic NameGuaifenesin And Dextromethorphan Hbr
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2021-07-01
Marketing CategoryANDA /
Application NumberANDA214781
Labeler NameSUN PHARMACEUTICAL INDUSTRIES, INC.
Substance NameDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active Ingredient Strength60 mg/1; mg/1
Pharm ClassesDecreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 63304-110-54

1 BLISTER PACK in 1 CARTON (63304-110-54) > 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Start Date2021-07-01
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Guaifenesin and Dextromethorphan HBr" or generic name "Guaifenesin And Dextromethorphan Hbr"

NDCBrand NameGeneric Name
30142-948GUAIFENESIN AND DEXTROMETHORPHAN HBRGuaifenesin and Dextromethorphan HBr
30142-963GUAIFENESIN AND DEXTROMETHORPHAN HBRGuaifenesin and Dextromethorphan HBr
41163-030Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBr
41415-998Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan Hbr
41415-999Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBr
68788-7317Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBr
58602-714Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBr
58602-715Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBr
58602-825Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBr
58602-824Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBr
65162-039Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBr
65162-038Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBr
79395-002Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBr
58602-849Guaifenesin and Dextromethorphan HBrGuaifenesin and Dextromethorphan HBr
0363-0510Maximum Strength Mucus Relief DMGuaifenesin and Dextromethorphan HBr
41163-985Maximum Strength Mucus-DMGuaifenesin and Dextromethorphan HBr
46122-420Mucus DMGuaifenesin and Dextromethorphan HBr
11822-5330Mucus Relief Cough and Congestion DMGuaifenesin and Dextromethorphan HBr
17714-150Mucus Relief Cough and Congestion DMGuaifenesin and Dextromethorphan HBr
0363-0474Mucus Relief DMGuaifenesin and Dextromethorphan HBr
0363-0533Mucus Relief DMGuaifenesin and Dextromethorphan HBr
11673-611mucus relief DMGuaifenesin and Dextromethorphan HBr
21130-997MUCUS RELIEF DMGuaifenesin and Dextromethorphan HBr
21130-989Mucus Relief DM MAXIMUM STRENGTHGuaifenesin and Dextromethorphan HBr
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