NDC 15338-769

Guaifenesin

Guaifenesin

Guaifenesin is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Apace Packaging, Llc. The primary component is Guaifenesin.

Product ID15338-769_7b197f8e-6e14-7226-e053-2a91aa0ad2a9
NDC15338-769
Product TypeHuman Otc Drug
Proprietary NameGuaifenesin
Generic NameGuaifenesin
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2016-10-04
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameApace Packaging, LLC
Substance NameGUAIFENESIN
Active Ingredient Strength200 mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 15338-769-05

50 BLISTER PACK in 1 BOX, UNIT-DOSE (15338-769-05) > 1 TABLET in 1 BLISTER PACK (15338-769-11)
Marketing Start Date2016-10-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 15338-769-05 [15338076905]

Guaifenesin TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-10-04
Inactivation Date2020-01-31

NDC 15338-769-11 [15338076911]

Guaifenesin TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-10-04

Drug Details

Active Ingredients

IngredientStrength
GUAIFENESIN200 mg/1

OpenFDA Data

SPL SET ID:7b197f8e-6e13-7226-e053-2a91aa0ad2a9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197741

    • NDC Crossover Matching brand name "Guaifenesin" or generic name "Guaifenesin"

    NDCBrand NameGeneric Name
    0121-0744GUAIFENESINGUAIFENESIN
    0121-1488GUAIFENESINGUAIFENESIN
    0121-1744GUAIFENESINGUAIFENESIN
    0121-2232GUAIFENESINGUAIFENESIN
    0363-0028GuaifenesinGuaifenesin
    0363-0033GuaifenesinGuaifenesin
    70000-0106GuaifenesinGuaifenesin
    70518-1782GuaifenesinGuaifenesin
    0904-5154GuaifenesinGuaifenesin
    15338-769GuaifenesinGuaifenesin
    30142-703GuaifenesinGuaifenesin
    42291-313GuaifenesinGuaifenesin
    49349-511GuaifenesinGuaifenesin
    50383-063GuaifenesinGuaifenesin
    51660-070GUAIFENESINGUAIFENESIN
    55154-5780GUAIFENESINGUAIFENESIN
    55154-9437GuaifenesinGuaifenesin
    58657-509GuaifenesinGuaifenesin
    65162-037GuaifenesinGuaifenesin
    65162-036GuaifenesinGuaifenesin
    67046-251GuaifenesinGuaifenesin
    55154-9450GUAIFENESINGUAIFENESIN
    58602-810GuaifenesinGuaifenesin
    58602-811GuaifenesinGuaifenesin
    62207-569GUAIFENESINGUAIFENESIN
    79395-001GuaifenesinGuaifenesin
    69618-061GuaifenesinGuaifenesin
    58602-853GuaifenesinGuaifenesin
    63629-1156GuaifenesinGuaifenesin
    62207-839GUAIFENESINGUAIFENESIN
    62207-840GUAIFENESINGUAIFENESIN
    0363-0288childrens chest congestionGuaifenesin
    0113-0325Good Sense Mucus ERGuaifenesin
    0113-2023good sense mucus erguaifenesin
    0113-3650Good Sense Mucus ERGuaifenesin
    0113-0061good sense tussinGuaifenesin
    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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.