NDC 55111-798

Guaifenesin and Pseudoephedrine HCL

Guaifenesin And Pseudoephedrine Hcl

Guaifenesin and Pseudoephedrine HCL is a Oral Tablet, Extended Release in the Human Otc Drug category. It is labeled and distributed by Dr. Reddys Laboratories Limited. The primary component is Guaifenesin; Pseudoephedrine Hydrochloride.

Product ID55111-798_029cd2ef-2247-abda-d74e-4b589a7dae62
NDC55111-798
Product TypeHuman Otc Drug
Proprietary NameGuaifenesin and Pseudoephedrine HCL
Generic NameGuaifenesin And Pseudoephedrine Hcl
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2017-12-29
Marketing CategoryANDA / ANDA
Application NumberANDA208369
Labeler NameDr. Reddys Laboratories Limited
Substance NameGUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Active Ingredient Strength600 mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 55111-798-09

1 BLISTER PACK in 1 CARTON (55111-798-09) > 9 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Start Date2017-12-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55111-798-35 [55111079835]

Guaifenesin and Pseudoephedrine HCL TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA208369
Product TypeHUMAN OTC DRUG
Marketing Start Date2020-01-23

NDC 55111-798-09 [55111079809]

Guaifenesin and Pseudoephedrine HCL TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA208369
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-12-29

NDC 55111-798-18 [55111079818]

Guaifenesin and Pseudoephedrine HCL TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA208369
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2017-12-29

NDC 55111-798-41 [55111079841]

Guaifenesin and Pseudoephedrine HCL TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA208369
Product TypeHUMAN OTC DRUG
Marketing Start Date2020-03-11

NDC 55111-798-36 [55111079836]

Guaifenesin and Pseudoephedrine HCL TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA208369
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2017-12-29

Drug Details

Active Ingredients

IngredientStrength
GUAIFENESIN600 mg/1

OpenFDA Data

SPL SET ID:845a2dcc-9069-3141-ae13-f2063f36d130
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1244675
  • 1305603
    • UPC Code
  • 0355111799047

    • NDC Crossover Matching brand name "Guaifenesin and Pseudoephedrine HCL" or generic name "Guaifenesin And Pseudoephedrine Hcl"

    NDCBrand NameGeneric Name
    0363-0134Guaifenesin and Pseudoephedrine HClGuaifenesin and Pseudoephedrine HCl
    0363-9946Guaifenesin and Pseudoephedrine HClGuaifenesin and Pseudoephedrine HCl
    11822-0046Guaifenesin and Pseudoephedrine HClGuaifenesin and Pseudoephedrine HCL
    30142-137Guaifenesin and Pseudoephedrine HClGuaifenesin and Pseudoephedrine HCl
    51660-057Guaifenesin and Pseudoephedrine HClGuaifenesin and Pseudoephedrine HCl
    51660-058Guaifenesin and Pseudoephedrine HClGuaifenesin and Pseudoephedrine HCl
    55111-798Guaifenesin and Pseudoephedrine HCLGuaifenesin and Pseudoephedrine HCL
    55111-799Guaifenesin and Pseudoephedrine HCLGuaifenesin and Pseudoephedrine HCL
    58602-833Guaifenesin and Pseudoephedrine HClGuaifenesin and Pseudoephedrine HCl
    58602-834Guaifenesin and Pseudoephedrine HClGuaifenesin and Pseudoephedrine HCl
    70677-0110Guaifenesin and Pseudoephedrine HClGuaifenesin and Pseudoephedrine HCL
    79481-1002Guaifenesin and Pseudoephedrine HClGuaifenesin and Pseudoephedrine HCl
    49035-261Guaifenesin 1200 mg and Pseudoephedrine HCl 120 mgGuaifenesin and Pseudoephedrine HCL
    0363-1604Mucus Relief DGuaifenesin and Pseudoephedrine HCL
    0363-7064Mucus Relief DGuaifenesin and Pseudoephedrine HCL
    11822-7399Mucus Relief DGuaifenesin and Pseudoephedrine HCL
    69842-211Mucus Relief DGuaifenesin and Pseudoephedrine HCL
    70000-0608Mucus Relief DGuaifenesin and Pseudoephedrine HCL
    50991-212Poly-Vent IRGuaifenesin and Pseudoephedrine HCl
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