lansoprazole

Product NDC
56062-117
11-digit product format
560620117
Labeler code
56062
Product ID
56062-117_422f715c-59b5-4146-9729-4ef1ecc608ac
Type
HUMAN OTC DRUG
Nonproprietary name
Lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Publix Super Markets Inc
Application
ANDA202319
Marketing category
ANDA
Marketing start
2012-08-10
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
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
LANSOPRAZOLE15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K5C5T2QPG
Rxcui596843

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
56062-117-01lansoprazole1 in 1 CARTONCAPSULE, DELAYED RELEASE16
56062-117-01lansoprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE146
56062-117-03lansoprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE146
56062-117-03lansoprazole3 in 1 CARTONCAPSULE, DELAYED RELEASE36

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LANSOPRAZOLEACTIVE INGREDIENT0K5C5T2QPGLANSOPRAZOLE CAPSULE, DELAYED RELEASE [PUBLIX SUPER MARKETS INC]2
LANSOPRAZOLEACTIVE MOIETY0K5C5T2QPGLANSOPRAZOLE CAPSULE, DELAYED RELEASE [PUBLIX SUPER MARKETS INC]2
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHLANSOPRAZOLE CAPSULE, DELAYED RELEASE [PUBLIX SUPER MARKETS INC]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLANSOPRAZOLE CAPSULE, DELAYED RELEASE [PUBLIX SUPER MARKETS INC]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDLANSOPRAZOLE CAPSULE, DELAYED RELEASE [PUBLIX SUPER MARKETS INC]2
GELATININACTIVE INGREDIENT2G86QN327LLANSOPRAZOLE CAPSULE, DELAYED RELEASE [PUBLIX SUPER MARKETS INC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLANSOPRAZOLE CAPSULE, DELAYED RELEASE [PUBLIX SUPER MARKETS INC]2
MANNITOLINACTIVE INGREDIENT3OWL53L36ALANSOPRAZOLE CAPSULE, DELAYED RELEASE [PUBLIX SUPER MARKETS INC]2
MEGLUMINEINACTIVE INGREDIENT6HG8UB2MUYLANSOPRAZOLE CAPSULE, DELAYED RELEASE [PUBLIX SUPER MARKETS INC]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALANSOPRAZOLE CAPSULE, DELAYED RELEASE [PUBLIX SUPER MARKETS INC]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HLANSOPRAZOLE CAPSULE, DELAYED RELEASE [PUBLIX SUPER MARKETS INC]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JLANSOPRAZOLE CAPSULE, DELAYED RELEASE [PUBLIX SUPER MARKETS INC]2
TALCINACTIVE INGREDIENT7SEV7J4R1ULANSOPRAZOLE CAPSULE, DELAYED RELEASE [PUBLIX SUPER MARKETS INC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLANSOPRAZOLE CAPSULE, DELAYED RELEASE [PUBLIX SUPER MARKETS INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
56062-117LANSOPRAZOLE CAPSULE, DELAYED RELEASE [PUBLIX SUPER MARKETS INC]6Current NDC, Legacy NDC, 4 package rows20200421_e226a1eb-39c8-440a-9824-1e5ccddc249e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596843lansoprazole 15 MG Delayed Release Oral CapsulePSNe226a1eb-39c8-440a-9824-1e5ccddc249e6
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCDe226a1eb-39c8-440a-9824-1e5ccddc249e6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
56062-117-01560620117011 BOTTLE in 1 CARTON (56062-117-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2012-08-170000-00-00NoNoCurrent
56062-117-03560620117033 BOTTLE in 1 CARTON (56062-117-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2012-08-100000-00-00NoNoCurrent