FDA.reportPublic FDA data

good neighbor pharmacy lansoprazole

Product NDC
46122-698
11-digit product format
461220698
Labeler code
46122
Product ID
46122-698_60acf569-acd7-4f31-8136-1e89d260ae7f
Type
HUMAN OTC DRUG
Nonproprietary name
Lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Amerisource Bergen
Application
ANDA202319
Marketing category
ANDA
Marketing start
2021-07-09
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
good neighbor pharmacy 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
46122-698-04good neighbor pharmacy lansoprazole3 in 1 CARTONCAPSULE, DELAYED RELEASE33
46122-698-04good neighbor pharmacy lansoprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE143
46122-698-74good neighbor pharmacy lansoprazole1 in 1 CARTONCAPSULE, DELAYED RELEASE13
46122-698-74good neighbor pharmacy lansoprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE143

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-698-04EA - Each46122-698622d1ebb-588c-4483-a937-170ee885c66112023-04-07
46122-698-74EA - Each46122-698643c0bcc-76f1-456a-908f-ef6bfe4d24ee12023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-698GOOD NEIGHBOR PHARMACY LANSOPRAZOLE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [AMERISOURCE BERGEN]2Current NDC, Legacy NDC, 4 package rows20220811_a4ee8db4-8f8e-4326-bd32-43abd53be8e4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596843lansoprazole 15 MG Delayed Release Oral CapsulePSNa4ee8db4-8f8e-4326-bd32-43abd53be8e43
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCDa4ee8db4-8f8e-4326-bd32-43abd53be8e43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46122-698-04461220698043 BOTTLE in 1 CARTON (46122-698-04) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2021-07-090000-00-00NoNoCurrent
46122-698-74461220698741 BOTTLE in 1 CARTON (46122-698-74) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2021-07-090000-00-00NoNoCurrent