Lansoprazole

Product NDC
68071-5119
11-digit product format
680715119
Labeler code
68071
Product ID
68071-5119_1b546656-8c7f-31ce-e063-6294a90a09dd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA205868
Marketing category
ANDA
Marketing start
2018-06-04
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
2026-12-31

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
68071-5119-3Lansoprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE306
68071-5119-4Lansoprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE146

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-5119LANSOPRAZOLE CAPSULE, DELAYED RELEASE [NUCARE PHARMACEUTICALS,INC.]6Current NDC, Legacy NDC, 2 package rows20240621_9a277b9e-2e13-27c3-e053-2995a90a7ed5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311277lansoprazole 30 MG Delayed Release Oral CapsulePSN9a277b9e-2e13-27c3-e053-2995a90a7ed56
311277lansoprazole 30 MG Delayed Release Oral CapsuleSCD9a277b9e-2e13-27c3-e053-2995a90a7ed56

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-5119-36807151190330 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-5119-3) 2019-12-200000-00-00NoNoCurrent
68071-5119-46807151190414 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-5119-4) 2019-12-200000-00-00NoNoCurrent