Lansoprazole

Product NDC
21695-652
11-digit product format
216950652
Labeler code
21695
Product ID
21695-652_c119ed19-5dc6-4c03-b705-2616c65ef041
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Rebel Distributors Corp
Application
NDA020406
Marketing category
NDA
Marketing start
2009-11-11
Marketing end
0000-00-00
Substance
LANSOPRAZOLE
Active strength
30 mg/1
Pharmacologic classes
Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d6b97638-59f4-48e2-8959-569628732c46Product name920210622
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-652-30Lansoprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-652-30EA - Each21695-65261b61828-31ab-45ef-b544-8a56c021fdb012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LansoprazoleACTIVE INGREDIENT0K5C5T2QPGLANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
LansoprazoleACTIVE MOIETY0K5C5T2QPGLANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
D&C Red No. 28INACTIVE INGREDIENT767IP0Y5NHLANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDLANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
FD&C Green No. 3INACTIVE INGREDIENT3P3ONR6O1SLANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOALANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
hydroxypropyl celluloseINACTIVE INGREDIENTRFW2ET671PLANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
hydroxypropyl cellulose, low substitutedINACTIVE INGREDIENT2165RE0K14LANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
magnesium carbonateINACTIVE INGREDIENT0E53J927NALANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
methacrylic acid - ethyl acrylate copolymer (1:1) type aINACTIVE INGREDIENTNX76LV5T8JLANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
polyethylene glycolINACTIVE INGREDIENT3WJQ0SDW1ALANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HLANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4LANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
starch, cornINACTIVE INGREDIENTO8232NY3SJLANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
sucroseINACTIVE INGREDIENTC151H8M554LANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
talcINACTIVE INGREDIENT7SEV7J4R1ULANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPLANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-652LANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20101119_c119ed19-5dc6-4c03-b705-2616c65ef041.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596843lansoprazole 15 MG Delayed Release Oral CapsulePSNc119ed19-5dc6-4c03-b705-2616c65ef0411
311277lansoprazole 30 MG Delayed Release Oral CapsulePSNc119ed19-5dc6-4c03-b705-2616c65ef0411
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCDc119ed19-5dc6-4c03-b705-2616c65ef0411
311277lansoprazole 30 MG Delayed Release Oral CapsuleSCDc119ed19-5dc6-4c03-b705-2616c65ef0411

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-652-302169506523030 in 1 BOTTLEHistorical