NDC 66220-719

Kristalose

Lactulose

Kristalose is a Oral Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Cumberland Pharmaceuticals Inc.. The primary component is Lactulose.

Product ID66220-719_22d5911b-d3d5-464d-a7ae-a01fc51defb1
NDC66220-719
Product TypeHuman Prescription Drug
Proprietary NameKristalose
Generic NameLactulose
Dosage FormPowder, For Solution
Route of AdministrationORAL
Marketing Start Date2012-01-20
Marketing CategoryANDA / ANDA
Application NumberANDA074712
Labeler NameCumberland Pharmaceuticals Inc.
Substance NameLACTULOSE
Active Ingredient Strength10 g/10g
Pharm ClassesOsmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 66220-719-30

30 POUCH in 1 CARTON (66220-719-30) > 10 g in 1 POUCH (66220-719-01)
Marketing Start Date2012-01-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 66220-719-01 [66220071901]

Kristalose POWDER, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA074712
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-01-20

NDC 66220-719-30 [66220071930]

Kristalose POWDER, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA074712
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-01-20

Drug Details

Active Ingredients

IngredientStrength
LACTULOSE10 g/10g

OpenFDA Data

SPL SET ID:535dd1ea-b567-49f7-9a84-8ea91e78c466
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1251194
  • 1251196
  • 1251190
  • 1251192
  • UPC Code
  • 0366220729016
  • 0366220719017
  • Pharmacological Class

    • Osmotic Laxative [EPC]
    • Osmotic Activity [MoA]
    • Acidifying Activity [MoA]
    • Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
    • Osmotic Laxative [EPC]
    • Osmotic Activity [MoA]
    • Acidifying Activity [MoA]
    • Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]

    Medicade Reported Pricing

    66220071930 KRISTALOSE 10 GM PACKET

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Kristalose" or generic name "Lactulose"

    NDCBrand NameGeneric Name
    66220-719KristaloseKristalose
    66220-729KristaloseKristalose
    0116-4005LactuloseLactulose
    0121-0577LACTULOSELACTULOSE
    0121-0873LACTULOSELactulose
    0121-1154LACTULOSELACTULOSE
    0121-1746LACTULOSELACTULOSE
    0121-4577LACTULOSELACTULOSE
    0527-5120LACTULOSELACTULOSE
    0527-5125LACTULOSELACTULOSE
    0603-1378Lactuloselactulose
    13668-574LactuloseLactulose
    13668-580LactuloseLactulose

    Trademark Results [Kristalose]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    KRISTALOSE
    KRISTALOSE
    86448618 4811363 Live/Registered
    Cumberland Pharmaceuticals Inc.
    2014-11-07
    KRISTALOSE
    KRISTALOSE
    75767058 2439494 Live/Registered
    CUMBERLAND PHARMACEUTICALS INC.
    1999-08-03
    KRISTALOSE
    KRISTALOSE
    75366450 not registered Dead/Abandoned
    Bertek Pharmaceuticals Inc.
    1997-10-01

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