Lansoprazole

Product NDC
0363-0739
11-digit product format
003630739
Labeler code
0363
Product ID
0363-0739_95ffdfb7-f4c6-22bd-c15a-b3a2257845e9
Type
HUMAN OTC DRUG
Nonproprietary name
Lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Walgreen Co
Application
ANDA202194
Marketing category
ANDA
Marketing start
2012-05-18
Marketing end
0000-00-00
Substance
LANSOPRAZOLE
Active strength
15 mg/1
Pharmacologic classes
Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LansoprazoleACTIVE INGREDIENT0K5C5T2QPGLANSOPRAZOLE CAPSULE, DELAYED RELEASE [WALGREEN CO]1
LansoprazoleACTIVE MOIETY0K5C5T2QPGLANSOPRAZOLE CAPSULE, DELAYED RELEASE [WALGREEN CO]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLANSOPRAZOLE CAPSULE, DELAYED RELEASE [WALGREEN CO]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LANSOPRAZOLE CAPSULE, DELAYED RELEASE [WALGREEN CO]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLANSOPRAZOLE CAPSULE, DELAYED RELEASE [WALGREEN CO]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LANSOPRAZOLE CAPSULE, DELAYED RELEASE [WALGREEN CO]1
GELATININACTIVE INGREDIENT2G86QN327LLANSOPRAZOLE CAPSULE, DELAYED RELEASE [WALGREEN CO]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PLANSOPRAZOLE CAPSULE, DELAYED RELEASE [WALGREEN CO]1
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14LANSOPRAZOLE CAPSULE, DELAYED RELEASE [WALGREEN CO]1
MAGNESIUM CARBONATEINACTIVE INGREDIENT0E53J927NALANSOPRAZOLE CAPSULE, DELAYED RELEASE [WALGREEN CO]1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JLANSOPRAZOLE CAPSULE, DELAYED RELEASE [WALGREEN CO]1
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WELANSOPRAZOLE CAPSULE, DELAYED RELEASE [WALGREEN CO]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HLANSOPRAZOLE CAPSULE, DELAYED RELEASE [WALGREEN CO]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JLANSOPRAZOLE CAPSULE, DELAYED RELEASE [WALGREEN CO]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLANSOPRAZOLE CAPSULE, DELAYED RELEASE [WALGREEN CO]1
SUCROSEINACTIVE INGREDIENTC151H8M554LANSOPRAZOLE CAPSULE, DELAYED RELEASE [WALGREEN CO]1
TALCINACTIVE INGREDIENT7SEV7J4R1ULANSOPRAZOLE CAPSULE, DELAYED RELEASE [WALGREEN CO]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLANSOPRAZOLE CAPSULE, DELAYED RELEASE [WALGREEN CO]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0739LANSOPRAZOLE CAPSULE, DELAYED RELEASE [WALGREEN CO]4Legacy NDC20231103_f6c3bbad-1739-80de-feb3-f9d1d1e39544.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0739-27003630739272 BOTTLE in 1 PACKAGE, COMBINATION (0363-0739-27) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0363-0739-52) 2 bottle2012-05-180000-00-00NoNoCurrent
0363-0739-33003630739333 BOTTLE in 1 PACKAGE, COMBINATION (0363-0739-33) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0363-0739-52) 3 bottle2012-05-180000-00-00NoNoCurrent