Lansoprazole

Product NDC
63629-2341
11-digit product format
636292341
Labeler code
63629
Product ID
63629-2341_220a6897-1676-4ca5-843d-1b9574636ffd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203203
Marketing category
ANDA
Marketing start
2018-08-24
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
Rxcui311277

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
63629-2341-1Lansoprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE90102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2341-1EA - Each63629-2341b3c81692-6cf3-4c70-ac5e-d00ad8baa7a912021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2341LANSOPRAZOLE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 1 package rows20240112_ae03d05b-0a0f-4bae-bbdc-450b7b5f7a92.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311277lansoprazole 30 MG Delayed Release Oral CapsulePSNae03d05b-0a0f-4bae-bbdc-450b7b5f7a92102
311277lansoprazole 30 MG Delayed Release Oral CapsuleSCDae03d05b-0a0f-4bae-bbdc-450b7b5f7a92102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-2341-16362923410190 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63629-2341-1) 2021-04-190000-00-00NoNoCurrent