Lansoprazole

Product NDC
68071-3634
11-digit product format
680713634
Labeler code
68071
Product ID
68071-3634_2abca807-be61-8994-e063-6294a90a8871
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA203083
Marketing category
ANDA
Marketing start
2020-05-18
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
d6b97638-59f4-48e2-8959-569628732c46Product name920210622
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3634-3Lansoprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3634LANSOPRAZOLE CAPSULE, DELAYED RELEASE [NUCARE PHARMACEUTICALS,INC.]2Current NDC, 1 package rows20250104_1bbb8f3a-80bf-b881-e063-6294a90ab4f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596843lansoprazole 15 MG Delayed Release Oral CapsulePSN1bbb8f3a-80bf-b881-e063-6294a90ab4f22
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCD1bbb8f3a-80bf-b881-e063-6294a90ab4f22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68071-3634-36807136340330 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-3634-3) 2024-06-25NoNoHistorical