NDC 63187-341

Siltussin SA

Guaifenesin

Siltussin SA is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Proficient Rx Lp. The primary component is Guaifenesin.

Product ID63187-341_60bcaa48-58e6-4c7e-8482-a881a1a9ec92
NDC63187-341
Product TypeHuman Otc Drug
Proprietary NameSiltussin SA
Generic NameGuaifenesin
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date1998-10-05
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameProficient Rx LP
Substance NameGUAIFENESIN
Active Ingredient Strength100 mg/5mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 63187-341-08

237 mL in 1 BOTTLE, PLASTIC (63187-341-08)
Marketing Start Date2019-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63187-341-08 [63187034108]

Siltussin SA LIQUID
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-01-01

Drug Details

Active Ingredients

IngredientStrength
GUAIFENESIN100 mg/5mL

OpenFDA Data

SPL SET ID:226ce7e2-a0dd-4430-b19c-2ed9cc45a74e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 213160
  • 310604
  • NDC Crossover Matching brand name "Siltussin SA" or generic name "Guaifenesin"

    NDCBrand NameGeneric Name
    68788-9098Siltussin SASiltussin SA
    17856-0117Siltussin SASiltussin SA
    50090-2675Siltussin SASiltussin SA
    54838-117Siltussin SASiltussin SA
    63187-341Siltussin SASiltussin SA
    70518-2824Siltussin SASiltussin SA
    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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.