Lansoprazole

Product NDC
55154-4848
11-digit product format
551544848
Labeler code
55154
Product ID
55154-4848_88f76b5e-c4a7-4dec-a866-c9959fff8243
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lansoprazole
Dosage form
TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA208784
Marketing category
ANDA
Marketing start
2018-03-08
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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LANSOPRAZOLE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K5C5T2QPG
Rxcui351260

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
55154-4848-0Lansoprazole1 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING, D14
55154-4848-0Lansoprazole10 in 1 BAGTABLET, ORALLY DISINTEGRATING, D104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-4848LANSOPRAZOLE TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [CARDINAL HEALTH 107, LLC]3Current NDC, Legacy NDC, 2 package rows20240928_c9a43df0-efab-4486-860f-92afdb258c8b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351260lansoprazole 30 MG Delayed Release Disintegrating Oral TabletPSNc9a43df0-efab-4486-860f-92afdb258c8b5
351260lansoprazole 30 MG Disintegrating Oral TabletSCDc9a43df0-efab-4486-860f-92afdb258c8b5
351260lansoprazole 30 MG Delayed Release Disintegrating Oral TabletSYc9a43df0-efab-4486-860f-92afdb258c8b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-4848-05515448480010 BLISTER PACK in 1 BAG (55154-4848-0) / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK10 blister pack2018-03-080000-00-00NoNoCurrent