Members Mark Lansoprazole

Product NDC
68196-279
11-digit product format
681960279
Labeler code
68196
Product ID
68196-279_f560a1f1-8534-491c-9ab9-b517d7498270
Type
HUMAN OTC DRUG
Nonproprietary name
Lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Sam's West Inc
Application
ANDA202319
Marketing category
ANDA
Marketing start
2024-07-15
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
Members Mark 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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68196-279-01Members Mark Lansoprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE142
68196-279-03Members Mark Lansoprazole3 in 1 PACKAGECAPSULE, DELAYED RELEASE32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68196-279MEMBERS MARK LANSOPRAZOLE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [SAM'S WEST INC]2Current NDC, 2 package rows20240718_fee84ce3-a884-4944-a32b-72e69a1229d4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596843lansoprazole 15 MG Delayed Release Oral CapsulePSNfee84ce3-a884-4944-a32b-72e69a1229d42
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCDfee84ce3-a884-4944-a32b-72e69a1229d42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68196-279-016819602790114 in 1 BOTTLEHistorical
68196-279-03681960279033 BOTTLE in 1 PACKAGE (68196-279-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68196-279-01) 3 bottle2024-07-15NoNoCurrent