NDC 11716-1104

LEADER ADVANCED FORMULA EYE DROPS

Dextran 70

LEADER ADVANCED FORMULA EYE DROPS is a Ophthalmic Solution in the Human Otc Drug category. It is labeled and distributed by Hanlim Pharm. Co., Ltd.. The primary component is Dextran 70; Polyethylene Glycol 400; Povidone; Tetrahydrozoline Hydrochloride.

Product ID11716-1104_ddd93887-104b-4d41-8cdb-bf19ef9154a1
NDC11716-1104
Product TypeHuman Otc Drug
Proprietary NameLEADER ADVANCED FORMULA EYE DROPS
Generic NameDextran 70
Dosage FormSolution
Route of AdministrationOPHTHALMIC
Marketing Start Date2010-05-06
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart349
Labeler NameHANLIM PHARM. CO., LTD.
Substance NameDEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONE; TETRAHYDROZOLINE HYDROCHLORIDE
Active Ingredient Strength0 mL/mL; mL/mL; mL/mL; mL/mL
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 11716-1104-1

1 BOTTLE in 1 CARTON (11716-1104-1) > 15 mL in 1 BOTTLE
Marketing Start Date2010-05-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 11716-1104-1 [11716110401]

LEADER ADVANCED FORMULA EYE DROPS SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart349
Product TypeHUMAN OTC DRUG
Marketing Start Date2010-05-06
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
DEXTRAN 70.001 mL/mL

OpenFDA Data

SPL SET ID:01d4b9b9-7a16-428c-9194-d9437e17b133
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 996202
  • UPC Code
  • 0096295110418
  • NDC Crossover Matching brand name "LEADER ADVANCED FORMULA EYE DROPS" or generic name "Dextran 70"

    NDCBrand NameGeneric Name
    11716-1104LEADER ADVANCED FORMULA EYE DROPSDEXTRAN 70
    55910-005DG Health Sterile Advanced Relief EyeDextran 70
    11716-9637LEADER DRY EYE RELIEFDEXTRAN 70
    11716-0102PREMIER VALUE ADVANCED EYE DROPSDEXTRAN 70
    11716-0458SHOPKO ADVANCED FORMULA EYE DROPSDEXTRAN 70
    68788-0039Tears Renewed LubricantDEXTRAN 70
    11716-1188WALGREENS ARTIFICIAL TEARS EYE DROPSDEXTRAN 70
    11716-1167WALGREENS MAXIMUM RELIEF EYE DROPSDEXTRAN 70

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