Lansoprazole

Product NDC
70000-0612
11-digit product format
700000612
Labeler code
70000
Product ID
70000-0612_8540b91a-377b-abac-70c6-5433b7167307
Type
HUMAN OTC DRUG
Nonproprietary name
Lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
LEADER/ Cardinal Health 110, Inc.
Application
ANDA202194
Marketing category
ANDA
Marketing start
2022-10-26
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0612-1EA - Each70000-0612b3ac09fd-50a0-4b34-8bd5-301744cc35b412024-09-09
70000-0612-2EA - Each70000-0612b4b82c0a-7ec5-49c0-842e-381897148e3812024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0612LANSOPRAZOLE CAPSULE, DELAYED RELEASE [LEADER/ CARDINAL HEALTH 110, INC.]3Current NDC, Legacy NDC20241203_486838cd-17ee-c2df-4e05-aa6106dd8fd8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596843lansoprazole 15 MG Delayed Release Oral CapsulePSN486838cd-17ee-c2df-4e05-aa6106dd8fd85
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCD486838cd-17ee-c2df-4e05-aa6106dd8fd85

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0612-1700000612011 BOTTLE in 1 CARTON (70000-0612-1) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2022-10-260000-00-00NoNoCurrent
70000-0612-2700000612022 BOTTLE in 1 CARTON (70000-0612-2) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE2 bottle2022-10-260000-00-00NoNoCurrent
70000-0612-3700000612033 BOTTLE in 1 CARTON (70000-0612-3) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2022-10-260000-00-00NoNoCurrent