NDC 0536-1161

Mucus Relief DM Extended Release Caplets

Guaifenesin, Dextromethorphan Hbr

Mucus Relief DM Extended Release Caplets is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Rugby Laboratories, Inc.. The primary component is Dextromethorphan Hydrobromide; Guaifenesin.

Product ID0536-1161_065e9247-fa6a-4a64-9c83-5f76702f5288
NDC0536-1161
Product TypeHuman Otc Drug
Proprietary NameMucus Relief DM Extended Release Caplets
Generic NameGuaifenesin, Dextromethorphan Hbr
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-12-13
Marketing CategoryANDA / ANDA
Application NumberANDA209692
Labeler NameRugby Laboratories, Inc.
Substance NameDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active Ingredient Strength30 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 0536-1161-34

20 BLISTER PACK in 1 CARTON (0536-1161-34) > 1 TABLET in 1 BLISTER PACK
Marketing Start Date2018-12-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0536-1161-34 [00536116134]

Mucus Relief DM Extended Release Caplets TABLET
Marketing CategoryANDA
Application NumberANDA209692
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2018-12-13

NDC 0536-1161-37 [00536116137]

Mucus Relief DM Extended Release Caplets TABLET
Marketing CategoryANDA
Application NumberANDA209692
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2018-12-13

Drug Details

Active Ingredients

IngredientStrength
GUAIFENESIN600 mg/1

OpenFDA Data

SPL SET ID:69cd399a-0103-4543-bb06-c7cccffe9cc4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1298324
    • UPC Code
  • 0305361161347

    • NDC Crossover Matching brand name "Mucus Relief DM Extended Release Caplets" or generic name "Guaifenesin, Dextromethorphan Hbr"

    NDCBrand NameGeneric Name
    0363-0437Mucus Relief DM Extended Release CapletsGuaifenesin, Dextromethorphan HBr
    0363-0733Mucus Relief DM Extended Release CapletsGuaifenesin, Dextromethorphan HBr
    0536-1161Mucus Relief DM Extended Release CapletsGuaifenesin, Dextromethorphan HBr
    0536-1213Mucus Relief DM Extended Release CapletsGuaifenesin, Dextromethorphan HBr
    37012-730Mucus Relief DM Extended Release CapletsGuaifenesin, Dextromethorphan HBr
    41250-633Mucus Relief DM Extended Release CapletsGuaifenesin, Dextromethorphan HBr
    41250-934Mucus Relief DM Extended Release CapletsGuaifenesin, Dextromethorphan HBr
    49035-824Mucus Relief DM Extended Release CapletsGuaifenesin, Dextromethorphan HBr
    50090-6020Mucus Relief DM Extended Release CapletsGuaifenesin, Dextromethorphan HBr
    70000-0464Mucus Relief DM Extended Release CapletsMucus Relief DM Extended Release Caplets
    63868-870Mucus Relief DM Extended Release CapletsMucus Relief DM Extended Release Caplets
    47682-217Medique Guaicon DMSGuaifenesin, Dextromethorphan Hbr
    0904-6233MUCUS RELIEF DMGUAIFENESIN, DEXTROMETHORPHAN HBr
    11822-0733Mucus Relief DMGuaifenesin, Dextromethorphan HBr
    11822-7340Mucus Relief DMGuaifenesin, Dextromethorphan HBr
    21130-933Mucus Relief DMGuaifenesin, Dextromethorphan HBr
    37012-729Mucus Relief DMGuaifenesin, Dextromethorphan HBr
    49035-825Mucus Relief DMGuaifenesin, Dextromethorphan HBr
    11673-833Mucus Relief DM Extended ReleaseGuaifenesin, Dextromethorphan HBr
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