Lansoprazole

Product NDC
67877-274
11-digit product format
678770274
Labeler code
67877
Product ID
67877-274_4d50f130-c94b-412a-8a34-0c582a79af73
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA207394
Marketing category
ANDA
Marketing start
2019-01-20
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
Rxcui311277, 596843

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
67877-274-30Lansoprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE3020
67877-274-90Lansoprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE9020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-274-30EA - Each67877-274965775a3-fc63-4e11-a3ed-55e73268403412019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-274LANSOPRAZOLE CAPSULE, DELAYED RELEASE [ASCEND LABORATORIES, LLC]19Current NDC, Legacy NDC, 2 package rows20240612_9e246e79-2737-4cbb-ad5d-4e76893da3be.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596843lansoprazole 15 MG Delayed Release Oral CapsulePSN9e246e79-2737-4cbb-ad5d-4e76893da3be20
311277lansoprazole 30 MG Delayed Release Oral CapsulePSN9e246e79-2737-4cbb-ad5d-4e76893da3be20
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCD9e246e79-2737-4cbb-ad5d-4e76893da3be20
311277lansoprazole 30 MG Delayed Release Oral CapsuleSCD9e246e79-2737-4cbb-ad5d-4e76893da3be20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67877-274-306787702743030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-274-30) 2019-01-200000-00-00NoNoCurrent
67877-274-906787702749090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-274-90) 2019-01-200000-00-00NoNoCurrent