Lansoprazole

Product NDC
82461-713
11-digit product format
824610713
Labeler code
82461
Product ID
82461-713_1d65f51d-0c4e-4344-8669-691f5223e4c5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Medcore LLC
Application
ANDA207394
Marketing category
ANDA
Marketing start
2026-01-11
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lansoprazole
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LANSOPRAZOLE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K5C5T2QPG
Rxcui311277

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
d6b97638-59f4-48e2-8959-569628732c46Product name920210622
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82461-713-30Lansoprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82461-713-30EA - Each82461-713f410137a-af2b-4fcd-9423-4449e47df8bf12026-02-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311277lansoprazole 30 MG Delayed Release Oral CapsulePSN18b4020f-d7e6-42f8-838d-2b5da152530e1
311277lansoprazole 30 MG Delayed Release Oral CapsuleSCD18b4020f-d7e6-42f8-838d-2b5da152530e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82461-713-308246107133030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (82461-713-30) 2026-01-11NoNoCurrent