equaline lansoprazole

Product NDC
41163-150
11-digit product format
411630150
Labeler code
41163
Product ID
41163-150_3ff35fd3-1add-4850-9bed-8a954fe29f91
Type
HUMAN OTC DRUG
Nonproprietary name
Lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
United Natural Foods, Inc. dba UNFI
Application
ANDA202319
Marketing category
ANDA
Marketing start
2021-09-02
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
equaline 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
41163-150-01equaline lansoprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE144
41163-150-01equaline lansoprazole1 in 1 CARTONCAPSULE, DELAYED RELEASE14
41163-150-03equaline lansoprazole3 in 1 CARTONCAPSULE, DELAYED RELEASE34
41163-150-03equaline lansoprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE144

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-150EQUALINE LANSOPRAZOLE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [UNITED NATURAL FOODS, INC. DBA UNFI]4Current NDC, Legacy NDC, 4 package rows20250221_bf8c337c-4a45-46e6-ae8e-46df80ca66e3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596843lansoprazole 15 MG Delayed Release Oral CapsulePSNbf8c337c-4a45-46e6-ae8e-46df80ca66e34
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCDbf8c337c-4a45-46e6-ae8e-46df80ca66e34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41163-150-01411630150011 BOTTLE in 1 CARTON (41163-150-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2021-09-020000-00-00NoNoCurrent
41163-150-03411630150033 BOTTLE in 1 CARTON (41163-150-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2021-09-280000-00-00NoNoCurrent