FDA.reportPublic FDA data

Lansoprazole

Product NDC
68001-112
11-digit product format
680010112
Labeler code
68001
Product ID
68001-112_e1e35404-0cf3-e40d-e053-2995a90a3829
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
BluePoint Laboratories
Application
ANDA091269
Marketing category
ANDA
Marketing start
2013-12-01
Substance
LANSOPRAZOLE
Active strength
30 mg/1
Pharmacologic classes
Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lansoprazole
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LANSOPRAZOLE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K5C5T2QPG
Rxcui311277, 596843

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d6b97638-59f4-48e2-8959-569628732c46Product name920210622
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68001-112-03Lansoprazole500 in 1 BOTTLECAPSULE, DELAYED RELEASE50014
68001-112-04Lansoprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE3014
68001-112-05Lansoprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE9014

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
lansoprazoleACTIVE INGREDIENT0K5C5T2QPGLANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]3
lansoprazoleACTIVE MOIETY0K5C5T2QPGLANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]3
ammoniaINACTIVE INGREDIENT5138Q19F1XLANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]3
ferric oxide redINACTIVE INGREDIENT1K09F3G675LANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]3
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTLANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]3
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357LANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]3
gelatinINACTIVE INGREDIENT2G86QN327LLANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]3
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PLANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]3
hydroxypropyl cellulose, low substitutedINACTIVE INGREDIENT2165RE0K14LANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]3
magnesium carbonateINACTIVE INGREDIENT0E53J927NALANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]3
methacrylic acid - ethyl acrylate copolymer (1:1) Type AINACTIVE INGREDIENTNX76LV5T8JLANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]3
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1ALANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]3
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HLANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]3
propylene glycolINACTIVE INGREDIENT6DC9Q167V3LANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]3
raw sugarINACTIVE INGREDIENT8M707QY5GHLANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]3
shellacINACTIVE INGREDIENT46N107B71OLANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]3
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JLANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]3
starch, cornINACTIVE INGREDIENTO8232NY3SJLANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]3
sucroseINACTIVE INGREDIENTC151H8M554LANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]3
talcINACTIVE INGREDIENT7SEV7J4R1ULANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]3
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPLANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]3
lansoprazoleACTIVE INGREDIENT0K5C5T2QPGLANSOPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]1
lansoprazoleACTIVE MOIETY0K5C5T2QPGLANSOPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]1
ammoniaINACTIVE INGREDIENT5138Q19F1XLANSOPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLANSOPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]1
ferric oxide redINACTIVE INGREDIENT1K09F3G675LANSOPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]1
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTLANSOPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]1
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357LANSOPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]1
gelatinINACTIVE INGREDIENT2G86QN327LLANSOPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PLANSOPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]1
hydroxypropyl cellulose, low substitutedINACTIVE INGREDIENT2165RE0K14LANSOPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]1
magnesium carbonateINACTIVE INGREDIENT0E53J927NALANSOPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]1
methacrylic acid - ethyl acrylate copolymer (1:1) Type AINACTIVE INGREDIENTNX76LV5T8JLANSOPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]1
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1ALANSOPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]1
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HLANSOPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3LANSOPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]1
raw sugarINACTIVE INGREDIENT8M707QY5GHLANSOPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]1
shellacINACTIVE INGREDIENT46N107B71OLANSOPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]1
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JLANSOPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]1
starch, cornINACTIVE INGREDIENTO8232NY3SJLANSOPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]1
sucroseINACTIVE INGREDIENTC151H8M554LANSOPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]1
talcINACTIVE INGREDIENT7SEV7J4R1ULANSOPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPLANSOPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-112LANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]14Current NDC, Legacy NDC, 3 package rows20220623_924c5a35-4804-4e14-a2fc-2b84d186d257.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596843lansoprazole 15 MG Delayed Release Oral CapsulePSN924c5a35-4804-4e14-a2fc-2b84d186d25714
311277lansoprazole 30 MG Delayed Release Oral CapsulePSN924c5a35-4804-4e14-a2fc-2b84d186d25714
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCD924c5a35-4804-4e14-a2fc-2b84d186d25714
311277lansoprazole 30 MG Delayed Release Oral CapsuleSCD924c5a35-4804-4e14-a2fc-2b84d186d25714
596843lansoprazole 15 MG Delayed Release Oral CapsulePSNdee80a19-e514-41e6-9153-c959699d97b110
311277lansoprazole 30 MG Delayed Release Oral CapsulePSNdee80a19-e514-41e6-9153-c959699d97b110
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCDdee80a19-e514-41e6-9153-c959699d97b110
311277lansoprazole 30 MG Delayed Release Oral CapsuleSCDdee80a19-e514-41e6-9153-c959699d97b110

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68001-112-0368001011203500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68001-112-03) 2013-12-010000-00-00NoNoCurrent
68001-112-046800101120430 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68001-112-04) 2020-08-310000-00-00NoNoCurrent
68001-112-056800101120590 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68001-112-05) 2013-12-010000-00-00NoNoCurrent