Lansoprazole

Product NDC
57896-761
11-digit product format
578960761
Labeler code
57896
Product ID
57896-761_d4c48506-6a3d-4d6b-2c7c-4315b16f73a0
Type
HUMAN OTC DRUG
Nonproprietary name
Lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Gericare Pharmaceuticals
Application
ANDA202194
Marketing category
ANDA
Marketing start
2013-04-25
Marketing end
0000-00-00
Substance
LANSOPRAZOLE
Active strength
15 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57896-761LANSOPRAZOLE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [GERICARE PHARMACEUTICALS]4Legacy NDC20241203_62dce6af-b33d-fa49-7861-670565fdf6e1.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57896-761-42578960761423 BOTTLE in 1 PACKAGE, COMBINATION (57896-761-42) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2013-04-250000-00-00NoNoCurrent