Lansoprazole

Product NDC
0904-6662
11-digit product format
009046662
Labeler code
0904
Product ID
0904-6662_4e6196f7-1553-45f1-a927-8bf4bd55eb19
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA091269
Marketing category
ANDA
Marketing start
2010-10-15
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lansoprazole
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LANSOPRAZOLE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K5C5T2QPG
Rxcui311277

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
0904-6662-45Lansoprazole1 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE16
0904-6662-45Lansoprazole80 in 1 CARTONCAPSULE, DELAYED RELEASE806

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6662LANSOPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]5Current NDC, Legacy NDC, 2 package rows20250316_854e4235-4815-4461-9b9b-d3d783fb775d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311277lansoprazole 30 MG Delayed Release Oral CapsulePSN854e4235-4815-4461-9b9b-d3d783fb775d6
311277lansoprazole 30 MG Delayed Release Oral CapsuleSCD854e4235-4815-4461-9b9b-d3d783fb775d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6662-450090466624580 BLISTER PACK in 1 CARTON (0904-6662-45) / 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK80 blister pack2010-10-150000-00-00NoNoCurrent