Lansoprazole

Product NDC
50090-6079
11-digit product format
500906079
Labeler code
50090
Product ID
50090-6079_ceba1bb2-f850-4744-963e-92c4fa47edd2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA205868
Marketing category
ANDA
Marketing start
2018-06-04
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
50090-6079-0Lansoprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6079LANSOPRAZOLE CAPSULE, DELAYED RELEASE [A-S MEDICATION SOLUTIONS]3Current NDC, Legacy NDC, 1 package rows20231118_495d3ca8-d37d-440a-80ce-9342d9ff281a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596843lansoprazole 15 MG Delayed Release Oral CapsulePSN495d3ca8-d37d-440a-80ce-9342d9ff281a3
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCD495d3ca8-d37d-440a-80ce-9342d9ff281a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-6079-05009060790030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-6079-0) 2022-09-190000-00-00NoNoCurrent