Lansoprazole

Product NDC
68071-4456
11-digit product format
680714456
Labeler code
68071
Product ID
68071-4456_1a8d53cc-6fe3-1474-e063-6394a90a7951
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA091269
Marketing category
ANDA
Marketing start
2010-10-15
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-4456-62024-08-20C16284748780-19d75b9d0-5233-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use lansoprazole delayed-release capsules safely and effectively. See full prescribing information for lansoprazole delayed-release capsules delayed-release capsules LANSOPRAZOLE delayed-release capsules USP, for oral use For oral administration Initial U.S. Approval: 1995
68071-4456-62023-01-30C16284748780-19d75b9d0-5233-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use lansoprazole delayed-release capsules safely and effectively. See full prescribing information for lansoprazole delayed-release capsules delayed-release capsules LANSOPRAZOLE delayed-release capsules USP, for oral use For oral administration Initial U.S. Approval: 1995
68071-4456-62021-01-07C16284748780-19d75b9d0-5233-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use lansoprazole delayed-release capsules safely and effectively. See full prescribing information for lansoprazole delayed-release capsules delayed-release capsules LANSOPRAZOLE delayed-release capsules USP, for oral use For oral administration Initial U.S. Approval: 1995
68071-4456-62020-01-31C16284748780-19d75b9d0-5233-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use lansoprazole delayed-release capsules safely and effectively. See full prescribing information for lansoprazole delayed-release capsules delayed-release capsules LANSOPRAZOLE delayed-release capsules USP, for oral use For oral administration Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4456-6Lansoprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4456LANSOPRAZOLE CAPSULE, DELAYED RELEASE [NUCARE PHARMACEUTICALS,INC.]4Current NDC, Legacy NDC, 1 package rows20240822_6d81faf7-aa59-429c-e053-2a91aa0a8bb2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596843lansoprazole 15 MG Delayed Release Oral CapsulePSN6d81faf7-aa59-429c-e053-2a91aa0a8bb24
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCD6d81faf7-aa59-429c-e053-2a91aa0a8bb24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-4456-66807144560660 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-4456-6) 2018-05-310000-00-00NoNoCurrent