FDA.reportPublic FDA data

Lansoprazole

Product NDC
31722-571
11-digit product format
317220571
Labeler code
31722
Product ID
31722-571_03b7dceb-2128-4324-b068-7f76a2d9887e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA203083
Marketing category
ANDA
Marketing start
2020-05-18
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, 596843

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
31722-571-01Lansoprazole100 in 1 BOTTLECAPSULE, DELAYED RELEASE1001
31722-571-05Lansoprazole500 in 1 BOTTLECAPSULE, DELAYED RELEASE5001
31722-571-10Lansoprazole1000 in 1 BOTTLECAPSULE, DELAYED RELEASE10001
31722-571-30Lansoprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE301
31722-571-90Lansoprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-571LANSOPRAZOLE CAPSULE, DELAYED RELEASE [CAMBER PHARMACEUTICALS, INC.]1Current NDC, Legacy NDC, 5 package rows20200805_03b7dceb-2128-4324-b068-7f76a2d9887e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596843lansoprazole 15 MG Delayed Release Oral CapsulePSN03b7dceb-2128-4324-b068-7f76a2d9887e1
311277lansoprazole 30 MG Delayed Release Oral CapsulePSN03b7dceb-2128-4324-b068-7f76a2d9887e1
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCD03b7dceb-2128-4324-b068-7f76a2d9887e1
311277lansoprazole 30 MG Delayed Release Oral CapsuleSCD03b7dceb-2128-4324-b068-7f76a2d9887e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
31722-571-0131722057101100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-571-01) 2020-05-180000-00-00NoNoCurrent
31722-571-0531722057105500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-571-05) 2020-05-180000-00-00NoNoCurrent
31722-571-10317220571101000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-571-10) 2020-05-180000-00-00NoNoCurrent
31722-571-303172205713030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-571-30) 2020-05-180000-00-00NoNoCurrent
31722-571-903172205719090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-571-90) 2020-05-180000-00-00NoNoCurrent