NDC 67618-121

Colace

Docusate Sodium - Sennosides

Colace is a Oral Tablet, Film Coated in the Human Otc Drug category. It is labeled and distributed by Avrio Health L.p.. The primary component is Docusate Sodium; Sennosides.

Product ID67618-121_b29acda5-704c-a2ee-c5d1-43c69de776b7
NDC67618-121
Product TypeHuman Otc Drug
Proprietary NameColace
Generic NameDocusate Sodium - Sennosides
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date1957-02-08
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart334
Labeler NameAvrio Health L.P.
Substance NameDOCUSATE SODIUM; SENNOSIDES
Active Ingredient Strength50 mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 67618-121-04

1 BLISTER PACK in 1 CARTON (67618-121-04) > 4 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date1957-02-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67618-121-04 [67618012104]

Colace TABLET, FILM COATED
Marketing CategoryOTC monograph not final
Application Numberpart334
Product TypeHUMAN OTC DRUG
Marketing Start Date1957-02-08
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
DOCUSATE SODIUM50 mg/1

OpenFDA Data

SPL SET ID:9fce5c4b-1e2e-47ef-13e5-c3bd5320d41b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1872920
  • 998740
  • NDC Crossover Matching brand name "Colace" or generic name "Docusate Sodium - Sennosides"

    NDCBrand NameGeneric Name
    67618-101ColaceDocusate sodium
    67618-110ColaceDocusate sodium - sennosides
    67618-111ColaceDocusate sodium
    67618-121ColaceDocusate sodium - sennosides
    67618-372ColaceDocusate sodium
    70518-3319ColaceDocusate sodium
    70000-0229DOCUSATE SODIUM - SENNOSIDESDOCUSATE SODIUM - SENNOSIDES
    67618-106Peri-ColaceDocusate sodium - sennosides

    Trademark Results [Colace]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    COLACE
    COLACE
    72001649 0670133 Live/Registered
    MEAD JOHNSON & COMPANY
    1956-01-30

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