FDA.reportPublic FDA data

Lansoprazole

Product NDC
69842-755
11-digit product format
698420755
Labeler code
69842
Product ID
69842-755_c51f66b9-1b2c-4730-81c3-63d58e939862
Type
HUMAN OTC DRUG
Nonproprietary name
Lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
CVS Pharmacy
Application
ANDA203187
Marketing category
ANDA
Marketing start
2019-03-31
Marketing end
2026-12-31
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lansoprazole

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69842-755-142020-10-26C16284748780-1ab0e2407-26b7-f274-e053-dbdaa90a6471DRUG FACTS
69842-755-282020-10-26C16284748780-1ab0e2407-26b7-f274-e053-dbdaa90a6471DRUG FACTS
69842-755-422020-10-26C16284748780-1ab0e2407-26b7-f274-e053-dbdaa90a6471DRUG FACTS
69842-755-142020-09-27C16284748780-1ab0e2407-26b7-f274-e053-dbdaa90a6471DRUG FACTS
69842-755-282020-09-27C16284748780-1ab0e2407-26b7-f274-e053-dbdaa90a6471DRUG FACTS
69842-755-422020-09-27C16284748780-1ab0e2407-26b7-f274-e053-dbdaa90a6471DRUG FACTS
69842-755-142020-09-25C16284748780-1ab0e2407-26b7-f274-e053-dbdaa90a6471DRUG FACTS
69842-755-282020-09-25C16284748780-1ab0e2407-26b7-f274-e053-dbdaa90a6471DRUG FACTS
69842-755-422020-09-25C16284748780-1ab0e2407-26b7-f274-e053-dbdaa90a6471DRUG FACTS
69842-755-142020-07-22C16284748780-1ab0e2407-26b7-f274-e053-dbdaa90a6471DRUG FACTS
69842-755-282020-07-22C16284748780-1ab0e2407-26b7-f274-e053-dbdaa90a6471DRUG FACTS
69842-755-422020-07-22C16284748780-1ab0e2407-26b7-f274-e053-dbdaa90a6471DRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-755-14Lansoprazole1 in 1 CARTONCAPSULE, DELAYED RELEASE14
69842-755-14Lansoprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE144
69842-755-28Lansoprazole2 in 1 BOXCAPSULE, DELAYED RELEASE24
69842-755-28Lansoprazole14 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE144
69842-755-42Lansoprazole14 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE144
69842-755-42Lansoprazole3 in 1 BOXCAPSULE, DELAYED RELEASE34

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-755LANSOPRAZOLE CAPSULE, DELAYED RELEASE [CVS PHARMACY]3Current NDC, Legacy NDC, 6 package rows20221123_d52b26e2-3d2a-4067-a28b-8697f865f582.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596843lansoprazole 15 MG Delayed Release Oral CapsulePSNd52b26e2-3d2a-4067-a28b-8697f865f5824
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCDd52b26e2-3d2a-4067-a28b-8697f865f5824

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-755-14698420755141 BOTTLE in 1 CARTON (69842-755-14) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2019-03-312026-12-31NoNoCurrent
69842-755-28698420755282 BOTTLE, PLASTIC in 1 BOX (69842-755-28) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC2019-03-312026-12-31NoNoCurrent
69842-755-42698420755423 BOTTLE, PLASTIC in 1 BOX (69842-755-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC2019-03-312026-12-31NoNoCurrent