FDA.reportPublic FDA data

Lansoprazole

Product NDC
43598-561
11-digit product format
435980561
Labeler code
43598
Product ID
43598-561_9d1837b8-8381-eef1-3cc8-a1738b66b5d6
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
2026-09-30
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lansoprazole

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
43598-561-78Lansoprazole100 in 1 CARTONTABLET, ORALLY DISINTEGRATING, D10011
43598-561-79Lansoprazole10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING, D1011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-561-78EA - Each43598-56165f2c2d5-aabe-4416-87e4-aea64cc845f712021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-561LANSOPRAZOLE TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [DR.REDDYS LABORATORIES INC]11Current NDC, Legacy 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
43598-561-7843598056178100 BLISTER PACK in 1 CARTON (43598-561-78) / 10 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK (43598-561-79) 100 blister pack2021-02-012026-09-30NoNoCurrent
43598-561-794359805617910 in 1 BLISTER PACKHistorical