NDC 0023-4307

REFRESH OPTIVE Advanced

Carboxymethylcellulose Sodium, Glycerin, And Polysorbate 80

REFRESH OPTIVE Advanced is a Ophthalmic Solution/ Drops in the Human Otc Drug category. It is labeled and distributed by Allergan, Inc.. The primary component is Carboxymethylcellulose Sodium; Glycerin; Polysorbate 80.

Product ID0023-4307_26dbb2cb-bf55-4f66-bee4-ee40546108de
NDC0023-4307
Product TypeHuman Otc Drug
Proprietary NameREFRESH OPTIVE Advanced
Generic NameCarboxymethylcellulose Sodium, Glycerin, And Polysorbate 80
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date2011-11-30
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart349
Labeler NameAllergan, Inc.
Substance NameCARBOXYMETHYLCELLULOSE SODIUM; GLYCERIN; POLYSORBATE 80
Active Ingredient Strength5 mg/mL; mg/mL; mg/mL
Pharm ClassesAllergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0023-4307-02

1 BOTTLE in 1 CARTON (0023-4307-02) > 2 mL in 1 BOTTLE
Marketing Start Date2011-11-30
NDC Exclude FlagN
Sample Package?Y

NDC SPL Data Element Entries

NDC 0023-4307-10 [00023430710]

REFRESH OPTIVE Advanced SOLUTION/ DROPS
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart349
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2011-11-30

NDC 0023-4307-03 [00023430703]

REFRESH OPTIVE Advanced SOLUTION/ DROPS
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart349
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-11-30

NDC 0023-4307-20 [00023430720]

REFRESH OPTIVE Advanced SOLUTION/ DROPS
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart349
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2011-11-30

NDC 0023-4307-15 [00023430715]

REFRESH OPTIVE Advanced SOLUTION/ DROPS
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart349
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-06-04
Marketing End Date2016-01-28

Drug Details

Active Ingredients

IngredientStrength
CARBOXYMETHYLCELLULOSE SODIUM5 mg/mL

OpenFDA Data

SPL SET ID:aaa943e4-7c38-4c5a-b7c0-5a656d8cafc0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1241471
  • UPC Code
  • 0300234307105
  • NDC Crossover Matching brand name "REFRESH OPTIVE Advanced" or generic name "Carboxymethylcellulose Sodium, Glycerin, And Polysorbate 80"

    NDCBrand NameGeneric Name
    0023-4307REFRESH OPTIVE Advancedcarboxymethylcellulose sodium, glycerin, and polysorbate 80
    0023-4491REFRESH OPTIVE Advancedcarboxymethylcellulose sodium, glycerin, polysorbate 80

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