Lansoprazole

Product NDC
51316-006
11-digit product format
513160006
Labeler code
51316
Product ID
51316-006_5bdd3776-8724-d578-b400-146e445c9db4
Type
HUMAN OTC DRUG
Nonproprietary name
Lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
CVS Pharmacy, Inc
Application
ANDA202194
Marketing category
ANDA
Marketing start
2022-10-01
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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-006LANSOPRAZOLE (LANSOPRAZOLE ) CAPSULE, DELAYED RELEASE [CVS PHARMACY, INC]3Current NDC, Legacy NDC20241203_8559bb6a-8498-1432-b46e-0ef532b4f04e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596843lansoprazole 15 MG Delayed Release Oral CapsulePSN8559bb6a-8498-1432-b46e-0ef532b4f04e4
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCD8559bb6a-8498-1432-b46e-0ef532b4f04e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51316-006-14513160006141 BOTTLE in 1 CARTON (51316-006-14) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2022-10-010000-00-00NoNoCurrent
51316-006-28513160006282 BOTTLE in 1 CARTON (51316-006-28) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE2 bottle2022-10-010000-00-00NoNoCurrent
51316-006-42513160006423 BOTTLE in 1 CARTON (51316-006-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2022-10-010000-00-00NoNoCurrent