FDA.reportPublic FDA data

Lansoprazole

Product NDC
72603-313
11-digit product format
726030313
Labeler code
72603
Product ID
72603-313_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
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
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
72603-313-01Lansoprazole10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING, D101
72603-313-10Lansoprazole10 in 1 CARTONTABLET, ORALLY DISINTEGRATING, D101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-313-01EA - Each72603-31301a4d3f8-7c8a-4a06-9b63-2c54fb50f96212025-02-10
72603-313-10EA - Each72603-313566ce292-033b-4f15-89b4-c7779b7f898c12025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-313LANSOPRAZOLE 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
72603-313-017260303130110 in 1 BLISTER PACKHistorical
72603-313-107260303131010 BLISTER PACK in 1 CARTON (72603-313-10) / 10 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK (72603-313-01) 10 blister pack2023-03-28NoNoCurrent