NDC 0280-1660

Alka-Seltzer Plus Maximum Strength Cough and Mucus DM

Dextromethorphan Hydrobromide, Guaifenesin

Alka-Seltzer Plus Maximum Strength Cough and Mucus DM is a Oral Tablet, Extended Release in the Human Otc Drug category. It is labeled and distributed by Bayer Healthcare Llc.. The primary component is Dextromethorphan Hydrobromide; Guaifenesin.

Product ID0280-1660_78d2a1b8-546c-4922-e053-2991aa0a4b7c
NDC0280-1660
Product TypeHuman Otc Drug
Proprietary NameAlka-Seltzer Plus Maximum Strength Cough and Mucus DM
Generic NameDextromethorphan Hydrobromide, Guaifenesin
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2018-07-02
Marketing CategoryANDA / ANDA
Application NumberANDA207602
Labeler NameBayer HealthCare LLC.
Substance NameDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active Ingredient Strength60 mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0280-1660-07

1 BLISTER PACK in 1 CARTON (0280-1660-07) > 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Start Date2018-10-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0280-1660-07 [00280166007]

Alka-Seltzer Plus Maximum Strength Cough and Mucus DM TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA207602
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-10-02

NDC 0280-1660-14 [00280166014]

Alka-Seltzer Plus Maximum Strength Cough and Mucus DM TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA207602
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-07-02

NDC 0280-1660-28 [00280166028]

Alka-Seltzer Plus Maximum Strength Cough and Mucus DM TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA207602
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-07-02
Marketing End Date2020-09-30

Drug Details

Active Ingredients

IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE60 mg/1

OpenFDA Data

SPL SET ID:6f28a94a-1107-860d-e053-2991aa0a663e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1099074
    • UPC Code
  • 0016500577850

    • NDC Crossover Matching brand name "Alka-Seltzer Plus Maximum Strength Cough and Mucus DM" or generic name "Dextromethorphan Hydrobromide, Guaifenesin"

    NDCBrand NameGeneric Name
    0280-1660Alka-Seltzer Plus Maximum Strength Cough and Mucus DMDextromethorphan Hydrobromide, Guaifenesin
    0363-1603adult tussin dmdextromethorphan hydrobromide, guaifenesin
    0280-0089Alka Seltzer Plus Maximum Strength Cough Chest Congestion PowerFast Fizzdextromethorphan hydrobromide, guaifenesin
    0113-7419basic care mucus dmdextromethorphan hydrobromide, guaifenesin
    0536-1313Chest Congestion ReliefDextromethorphan Hydrobromide, Guaifenesin
    0904-7134Chest Congestion ReliefDextromethorphan Hydrobromide, Guaifenesin
    0904-7135Chest Congestion ReliefDextromethorphan Hydrobromide, Guaifenesin
    0031-8715Childrens Robitussin Cough and Chest Congestion DMdextromethorphan hydrobromide, guaifenesin
    0363-0419CoughDextromethorphan Hydrobromide, Guaifenesin
    0113-0419Good Sense Childrens Mucus Relief CoughDextromethorphan Hydrobromide, Guaifenesin
    0113-2219Good Sense Mucus DMdextromethorphan hydrobromide, guaifenesin
    0113-0359good sense tussin dmDextromethorphan Hydrobromide, Guaifenesin
    0113-1725good sense tussin dmdextromethorphan hydrobromide, guaifenesin
    0363-0505Mucus Relief DMdextromethorphan hydrobromide, guaifenesin
    0363-6812mucus relief dmdextromethorphan hydrobromide, guaifenesin
    0904-7223robafen dmdextromethorphan hydrobromide, guaifenesin
    0031-8765Robitussin Maximum Strength 12 Hour Cough and Mucus ReliefDextromethorphan Hydrobromide, Guaifenesin
    0031-8739ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DMdextromethorphan hydrobromide, guaifenesin
    0031-8759Robitussin Sugar-Free Dye-Free Cough Plus Chest Congestion DMdextromethorphan hydrobromide, guaifenesin
    0536-1348rugby cough syrupdextromethorphan hydrobromide, guaifenesin
    0372-0050Scot-Tussin Senior SF DMEXPDextromethorphan Hydrobromide, Guaifenesin
    0067-8118TriaminicDextromethorphan Hydrobromide, Guaifenesin
    0363-1144tussin dm maxDextromethorphan Hydrobromide, Guaifenesin
    0904-5180Tussin Sugar Free CoughDextromethorphan Hydrobromide, GUAIFENESIN
    11673-235up and up maximum strength mucus relief dmdextromethorphan hydrobromide, guaifenesin
    0363-0359Wal TussinDextromethorphan Hydrobromide, Guaifenesin
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