FDA.reportPublic FDA data

Lansoprazole

Product NDC
70700-263
11-digit product format
707000263
Labeler code
70700
Product ID
70700-263_ce9167b4-3b92-9cbd-f4f5-a8788ed0d47a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Xiromed LLC
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, 596843

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
d6b97638-59f4-48e2-8959-569628732c46Product name920210622
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70700-263-05Lansoprazole500 in 1 BOTTLECAPSULE, DELAYED RELEASE50022
70700-263-30Lansoprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE3022
70700-263-90Lansoprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE9022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70700-263-05EA - Each70700-263cad90b48-0c0f-40eb-84fa-b2a0ece1294112017-08-11
70700-263-30EA - Each70700-263ffbf39e2-43ec-4ec2-bb95-db79b01c4abb12017-06-15
70700-263-90EA - Each70700-263938097f9-9945-4597-ab42-1e74411fedd412017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70700-263LANSOPRAZOLE CAPSULE, DELAYED RELEASE [XIROMED LLC]22Current NDC, Legacy NDC, 3 package rows20230707_00a574e0-bd03-deea-9f85-b108f78982ba.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 CapsulePSNa612a237-ec17-49f0-8985-44407608adb5102
311277lansoprazole 30 MG Delayed Release Oral CapsulePSN1dc026b6-b521-4a46-9a74-8c1c140d5329102
311277lansoprazole 30 MG Delayed Release Oral CapsulePSN44f07613-35be-4673-98f0-4b2467acce9c102
311277lansoprazole 30 MG Delayed Release Oral CapsuleSCDae03d05b-0a0f-4bae-bbdc-450b7b5f7a92102
311277lansoprazole 30 MG Delayed Release Oral CapsuleSCDa612a237-ec17-49f0-8985-44407608adb5102
311277lansoprazole 30 MG Delayed Release Oral CapsuleSCD1dc026b6-b521-4a46-9a74-8c1c140d5329102
311277lansoprazole 30 MG Delayed Release Oral CapsuleSCD44f07613-35be-4673-98f0-4b2467acce9c102
311277lansoprazole 30 MG Delayed Release Oral CapsulePSNe0299cf2-8a8e-499b-a81e-16e844ea3aff100
311277lansoprazole 30 MG Delayed Release Oral CapsuleSCDe0299cf2-8a8e-499b-a81e-16e844ea3aff100
596843lansoprazole 15 MG Delayed Release Oral CapsulePSN00a574e0-bd03-deea-9f85-b108f78982ba22
311277lansoprazole 30 MG Delayed Release Oral CapsulePSN00a574e0-bd03-deea-9f85-b108f78982ba22
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCD00a574e0-bd03-deea-9f85-b108f78982ba22
311277lansoprazole 30 MG Delayed Release Oral CapsuleSCD00a574e0-bd03-deea-9f85-b108f78982ba22
311277lansoprazole 30 MG Delayed Release Oral CapsulePSNa9dd7e56-1aee-5f0b-e053-2995a90a43bf6
311277lansoprazole 30 MG Delayed Release Oral CapsuleSCDa9dd7e56-1aee-5f0b-e053-2995a90a43bf6
311277lansoprazole 30 MG Delayed Release Oral CapsulePSN3babf7d9-ad83-4e44-8e5d-f6c11b2d76b65
311277lansoprazole 30 MG Delayed Release Oral CapsuleSCD3babf7d9-ad83-4e44-8e5d-f6c11b2d76b65
311277lansoprazole 30 MG Delayed Release Oral CapsulePSNdb42468a-450c-4b12-b2f2-e9a76e976d453
311277lansoprazole 30 MG Delayed Release Oral CapsuleSCDdb42468a-450c-4b12-b2f2-e9a76e976d453
311277lansoprazole 30 MG Delayed Release Oral CapsulePSN37b221ee-b6a4-76e8-e063-6394a90a7e0b1
311277lansoprazole 30 MG Delayed Release Oral CapsulePSN16dc1e02-4679-4d7f-a65b-6e3706655d351
311277lansoprazole 30 MG Delayed Release Oral CapsulePSN11344047-7ed4-61e7-e063-6394a90a332d1
311277lansoprazole 30 MG Delayed Release Oral CapsuleSCD37b221ee-b6a4-76e8-e063-6394a90a7e0b1
311277lansoprazole 30 MG Delayed Release Oral CapsuleSCD16dc1e02-4679-4d7f-a65b-6e3706655d351
311277lansoprazole 30 MG Delayed Release Oral CapsuleSCD11344047-7ed4-61e7-e063-6394a90a332d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70700-263-0570700026305500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70700-263-05) 2018-08-240000-00-00NoNoCurrent
70700-263-307070002633030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70700-263-30) 2018-08-240000-00-00NoNoCurrent
70700-263-907070002639090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70700-263-90) 2018-08-240000-00-00NoNoCurrent