NDC 68196-997

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 Sam's West Inc. The primary component is Dextromethorphan Hydrobromide; Guaifenesin.

Product ID68196-997_298f18eb-cec6-44f9-8e92-a393c5975a65
NDC68196-997
Product TypeHuman Otc Drug
Proprietary NameGuaifenesin and Dextromethorphan Hydrobromide
Generic NameGuaifenesin And Dextromethorphan Hydrobromide
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2022-02-16
Marketing CategoryANDA /
Application NumberANDA214781
Labeler NameSAM'S WEST 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 68196-997-56

1 BLISTER PACK in 1 CARTON (68196-997-56) > 4 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Start Date2022-02-16
NDC Exclude FlagN
Sample Package?N

Drug Details

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
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