FDA.reportPublic FDA data

Lansoprazole

Product NDC
67877-275
11-digit product format
678770275
Labeler code
67877
Product ID
67877-275_4d50f130-c94b-412a-8a34-0c582a79af73
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA207394
Marketing category
ANDA
Marketing start
2019-01-20
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
d6b97638-59f4-48e2-8959-569628732c46Product name920210622
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67877-275-05Lansoprazole500 in 1 BOTTLECAPSULE, DELAYED RELEASE50020
67877-275-30Lansoprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE3020
67877-275-90Lansoprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE9020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-275-05EA - Each67877-275b17fcd9c-e172-4a0f-a851-239e3a737f8512023-02-06
67877-275-30EA - Each67877-275b1940aed-345c-419f-950a-c1009a587db712019-11-12
67877-275-90EA - Each67877-275649b4053-c9ee-4af5-9624-25d0b14e72a112019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-275LANSOPRAZOLE CAPSULE, DELAYED RELEASE [ASCEND LABORATORIES, LLC]19Current NDC, Legacy NDC, 3 package rows20240612_9e246e79-2737-4cbb-ad5d-4e76893da3be.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596843lansoprazole 15 MG Delayed Release Oral CapsulePSN9e246e79-2737-4cbb-ad5d-4e76893da3be20
311277lansoprazole 30 MG Delayed Release Oral CapsulePSN9e246e79-2737-4cbb-ad5d-4e76893da3be20
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCD9e246e79-2737-4cbb-ad5d-4e76893da3be20
311277lansoprazole 30 MG Delayed Release Oral CapsuleSCD9e246e79-2737-4cbb-ad5d-4e76893da3be20
311277lansoprazole 30 MG Delayed Release Oral CapsulePSN8bbc3af5-faa1-4af1-94e9-9df4aae242ab7
311277lansoprazole 30 MG Delayed Release Oral CapsuleSCD8bbc3af5-faa1-4af1-94e9-9df4aae242ab7
311277lansoprazole 30 MG Delayed Release Oral CapsulePSN71be1129-8562-476e-9d9b-99a21cbf52ec2
311277lansoprazole 30 MG Delayed Release Oral CapsuleSCD71be1129-8562-476e-9d9b-99a21cbf52ec2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67877-275-0567877027505500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-275-05) 2021-06-01NoNoCurrent
67877-275-306787702753030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-275-30) 2019-01-200000-00-00NoNoCurrent
67877-275-906787702759090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-275-90) 2019-01-200000-00-00NoNoCurrent