FDA.reportPublic FDA data

lansoprazole

Product NDC
45802-878
11-digit product format
458020878
Labeler code
45802
Product ID
45802-878_5032a392-a20a-4246-b2cb-54d7e3a441f8
Type
HUMAN OTC DRUG
Nonproprietary name
Lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA202319
Marketing category
ANDA
Marketing start
2021-07-29
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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-878-01lansoprazole1 in 1 CARTONCAPSULE, DELAYED RELEASE15
45802-878-01lansoprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE145
45802-878-02lansoprazole2 in 1 CARTONCAPSULE, DELAYED RELEASE25
45802-878-02lansoprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE145
45802-878-03lansoprazole3 in 1 CARTONCAPSULE, DELAYED RELEASE35
45802-878-03lansoprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE145

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-878-01EA - Each45802-878793cd136-09b4-44ca-9e06-4e2e1d349c0912022-10-06
45802-878-02EA - Each45802-878b971c20a-c585-441f-83fb-db3d9eeec40a12022-10-06
45802-878-03EA - Each45802-8780a851aed-56dc-423c-bb4f-de3bc7ddd04512022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-878LANSOPRAZOLE CAPSULE, DELAYED RELEASE [PADAGIS ISRAEL PHARMACEUTICALS LTD]5Current NDC, Legacy NDC, 6 package rows20250331_17f41872-f3d1-4b02-b6ce-0e731139495a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596843lansoprazole 15 MG Delayed Release Oral CapsulePSNbd278054-875e-4877-991c-cbdf3975f93e102
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCDbd278054-875e-4877-991c-cbdf3975f93e102
596843lansoprazole 15 MG Delayed Release Oral CapsulePSN17f41872-f3d1-4b02-b6ce-0e731139495a5
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCD17f41872-f3d1-4b02-b6ce-0e731139495a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-878-01458020878011 BOTTLE in 1 CARTON (45802-878-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2021-07-290000-00-00NoNoCurrent
45802-878-02458020878022 BOTTLE in 1 CARTON (45802-878-02) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE2 bottle2021-07-290000-00-00NoNoCurrent
45802-878-03458020878033 BOTTLE in 1 CARTON (45802-878-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2021-07-290000-00-00NoNoCurrent