NDC 68391-117

Berkley and Jensen Lansoprazole

Lansoprazole

Berkley and Jensen Lansoprazole is a Oral Capsule, Delayed Release in the Human Otc Drug category. It is labeled and distributed by Bjwc. The primary component is Lansoprazole.

Product ID68391-117_0958c10e-f094-4f27-aa3f-a08a4caca4bf
NDC68391-117
Product TypeHuman Otc Drug
Proprietary NameBerkley and Jensen Lansoprazole
Generic NameLansoprazole
Dosage FormCapsule, Delayed Release
Route of AdministrationORAL
Marketing Start Date2012-05-22
Marketing CategoryANDA / ANDA
Application NumberANDA202319
Labeler NameBJWC
Substance NameLANSOPRAZOLE
Active Ingredient Strength15 mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68391-117-03

3 BOTTLE in 1 PACKAGE (68391-117-03) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
Marketing Start Date2012-05-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68391-117-03 [68391011703]

Berkley and Jensen Lansoprazole CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA202319
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-05-22

Drug Details

Active Ingredients

IngredientStrength
LANSOPRAZOLE15 mg/1

OpenFDA Data

SPL SET ID:5fbd8f66-401b-484a-8ec2-f2435840d328
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 596843
  • NDC Crossover Matching brand name "Berkley and Jensen Lansoprazole" or generic name "Lansoprazole"

    NDCBrand NameGeneric Name
    68391-117Berkley and Jensen LansoprazoleBerkley and Jensen Lansoprazole
    0113-7003Basic Care LansoprazoleLansoprazole
    0113-7116basic care lansoprazoleLansoprazole
    0113-0116Good Sense LansoprazoleLansoprazole
    0113-0117Good Sense lansoprazoleLansoprazole
    0113-1114Good Sense LansoprazoleLansoprazole
    0093-3008LansoprazoleLansoprazole
    0093-3009LansoprazoleLansoprazole
    0093-7350LansoprazoleLansoprazole
    0093-7351LansoprazoleLansoprazole
    0067-6286PrevacidLansoprazole
    0113-6002Prevacid 24 HRlansoprazole

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