Lansoprazole

Product NDC
46122-744
11-digit product format
461220744
Labeler code
46122
Product ID
46122-744_756f298d-53bd-cd28-216c-4e7d886fdee3
Type
HUMAN OTC DRUG
Nonproprietary name
Lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
AMERISOURCEBERGEN DRUG CORPORATION
Application
ANDA202194
Marketing category
ANDA
Marketing start
2022-04-12
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lansoprazole
Listing expiration
2027-12-31

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
46122-744LANSOPRAZOLE CAPSULE, DELAYED RELEASE [AMERISOURCEBERGEN DRUG CORPORATION]2Current NDC20241203_accb92e8-dd14-b87b-c20a-6c4803815bc2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596843lansoprazole 15 MG Delayed Release Oral CapsulePSNaccb92e8-dd14-b87b-c20a-6c4803815bc24
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCDaccb92e8-dd14-b87b-c20a-6c4803815bc24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46122-744-04461220744043 BOTTLE in 1 CARTON (46122-744-04) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2023-08-30NoNoCurrent
46122-744-74461220744741 BOTTLE in 1 CARTON (46122-744-74) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2023-08-302026-08-31NoNoHistorical