Lansoprazole

Product NDC
43598-560
11-digit product format
435980560
Labeler code
43598
Product ID
43598-560_dfac78f3-0f72-520c-52cb-d82d84c753be
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lansoprazole
Dosage form
TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
Route
ORAL
Labeler
Dr.Reddys Laboratories Inc
Application
ANDA210465
Marketing category
ANDA
Marketing start
2021-02-01
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

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
43598-560-78Lansoprazole100 in 1 CARTONTABLET, ORALLY DISINTEGRATING, D10011
43598-560-79Lansoprazole10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING, D1011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-560-78EA - Each43598-5604d5297de-6ce0-437d-a6ca-7ebdc6a7df2f12021-03-02
43598-560-79EA - Each43598-560e6913449-db90-464a-8fc1-ca97e9cf5a3012022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-560LANSOPRAZOLE TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [DR.REDDYS LABORATORIES INC]11Legacy NDC, 2 package rows20240612_656bc92a-1f95-047d-cd27-724073e63fe6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351261lansoprazole 15 MG Delayed Release Disintegrating Oral TabletPSN656bc92a-1f95-047d-cd27-724073e63fe611
351260lansoprazole 30 MG Delayed Release Disintegrating Oral TabletPSN656bc92a-1f95-047d-cd27-724073e63fe611
351261lansoprazole 15 MG Disintegrating Oral TabletSCD656bc92a-1f95-047d-cd27-724073e63fe611
351260lansoprazole 30 MG Disintegrating Oral TabletSCD656bc92a-1f95-047d-cd27-724073e63fe611
351261lansoprazole 15 MG Delayed Release Disintegrating Oral TabletSY656bc92a-1f95-047d-cd27-724073e63fe611
351260lansoprazole 30 MG Delayed Release Disintegrating Oral TabletSY656bc92a-1f95-047d-cd27-724073e63fe611

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-560-7843598056078100 BLISTER PACK in 1 CARTON (43598-560-78) > 10 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK (43598-560-79) 100 blister pack2021-02-010000-00-00NoNoCurrent
43598-560-794359805607910 in 1 BLISTER PACKHistorical