NDC 0536-1163

Mucus Relief Extended Release

Guaifenesin

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

Product ID0536-1163_20890674-dbb0-47f1-b4b7-cd955790a101
NDC0536-1163
Product TypeHuman Otc Drug
Proprietary NameMucus Relief Extended Release
Generic NameGuaifenesin
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-08-31
Marketing CategoryANDA / ANDA
Application NumberANDA207342
Labeler NameRugby Laboratories, Inc.
Substance NameGUAIFENESIN
Active Ingredient Strength600 mg/1
Pharm ClassesDecreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0536-1163-61

100 BLISTER PACK in 1 CARTON (0536-1163-61) > 1 TABLET in 1 BLISTER PACK
Marketing Start Date2018-08-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0536-1163-61 [00536116361]

Mucus Relief Extended Release TABLET
Marketing CategoryANDA
Application NumberANDA207342
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2018-08-31

Drug Details

Active Ingredients

IngredientStrength
GUAIFENESIN600 mg/1

OpenFDA Data

SPL SET ID:8bc6f08e-a941-4fa8-8dd6-a699abf2337d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 636522
  • UPC Code
  • 0305361163617
  • NDC Crossover Matching brand name "Mucus Relief Extended Release" or generic name "Guaifenesin"

    NDCBrand NameGeneric Name
    0536-1163Mucus Relief Extended ReleaseMucus Relief Extended Release
    0904-6718Mucus Relief Extended ReleaseMucus Relief Extended Release
    11673-732Mucus Relief Extended ReleaseMucus Relief Extended Release
    41250-732Mucus Relief Extended ReleaseMucus Relief Extended Release
    41520-731Mucus Relief Extended ReleaseMucus Relief Extended Release
    55319-732Mucus Relief Extended ReleaseMucus Relief Extended Release
    0363-0931Mucus Relief Extended ReleaseMucus Relief Extended Release
    62011-0377Mucus Relief Extended ReleaseMucus Relief Extended Release
    63868-871Mucus Relief Extended ReleaseMucus Relief Extended Release
    0363-0288childrens chest congestionGuaifenesin
    0113-0325Good Sense Mucus ERGuaifenesin
    0113-2023good sense mucus erguaifenesin
    0113-3650Good Sense Mucus ERGuaifenesin
    0113-0061good sense tussinGuaifenesin
    0121-0744GUAIFENESINGUAIFENESIN
    0121-1488GUAIFENESINGUAIFENESIN
    0121-1744GUAIFENESINGUAIFENESIN
    0121-2232GUAIFENESINGUAIFENESIN
    0363-0028GuaifenesinGuaifenesin
    0363-0033GuaifenesinGuaifenesin
    0363-0071MucusGuaifenesin
    0363-0074MucusGuaifenesin
    0363-0532Mucus ReliefGuaifenesin
    0363-0325mucus relief erGuaifenesin
    0031-9303Robitussin Direct Chest Congestionguaifenesin
    0031-8724Robitussin Mucus Plus Chest CongestionGuaifenesin
    0113-2061tussinGuaifenesin
    0363-0310wal tussinGuaifenesin

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