FDA.reportPublic FDA data

Lansoprazole

Product NDC
72603-314
11-digit product format
726030314
Labeler code
72603
Product ID
72603-314_ac051296-6fe3-4ab5-a001-cc3e06199a22
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lansoprazole
Dosage form
TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
Route
ORAL
Labeler
NorthStar Rx LLC
Application
ANDA207167
Marketing category
ANDA
Marketing start
2023-03-28
Substance
LANSOPRAZOLE
Active strength
30 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
LANSOPRAZOLE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K5C5T2QPG
Rxcui351260, 351261

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
72603-314-01Lansoprazole10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING, D101
72603-314-10Lansoprazole10 in 1 CARTONTABLET, ORALLY DISINTEGRATING, D101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-314-01EA - Each72603-314df13fce1-d86f-415e-a4ec-0a04bda23b2512025-02-10
72603-314-10EA - Each72603-314af9d9c84-1500-4875-a714-cad96573e9ca12025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-314LANSOPRAZOLE TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [NORTHSTAR RX LLC]1Current NDC, 2 package rows20240810_ac051296-6fe3-4ab5-a001-cc3e06199a22.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351261lansoprazole 15 MG Delayed Release Disintegrating Oral TabletPSNac051296-6fe3-4ab5-a001-cc3e06199a221
351260lansoprazole 30 MG Delayed Release Disintegrating Oral TabletPSNac051296-6fe3-4ab5-a001-cc3e06199a221
351261lansoprazole 15 MG Disintegrating Oral TabletSCDac051296-6fe3-4ab5-a001-cc3e06199a221
351260lansoprazole 30 MG Disintegrating Oral TabletSCDac051296-6fe3-4ab5-a001-cc3e06199a221
351261lansoprazole 15 MG Delayed Release Disintegrating Oral TabletSYac051296-6fe3-4ab5-a001-cc3e06199a221
351260lansoprazole 30 MG Delayed Release Disintegrating Oral TabletSYac051296-6fe3-4ab5-a001-cc3e06199a221

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72603-314-017260303140110 in 1 BLISTER PACKHistorical
72603-314-107260303141010 BLISTER PACK in 1 CARTON (72603-314-10) / 10 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK (72603-314-01) 10 blister pack2023-03-28NoNoCurrent