FDA.reportPublic FDA data

LANSOPRAZOLE

Product NDC
61919-245
11-digit product format
619190245
Labeler code
61919
Product ID
61919-245_94908284-aad8-7b83-e053-2995a90a12c7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LANSOPRAZOLE
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
DIRECT RX
Application
ANDA091269
Marketing category
ANDA
Marketing start
2014-01-01
Marketing end
0000-00-00
Substance
LANSOPRAZOLE
Active strength
15 mg/1
Pharmacologic classes
Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE]
NDC exclude flag
No
Listing certified through
2020-12-31
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-245-302023-01-30C16284748780-1f386c649-adea-0266-e053-dadaa90a7c1aLANSOPRAZOLE
61919-245-602023-01-30C16284748780-1f386c649-adea-0266-e053-dadaa90a7c1aLANSOPRAZOLE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-245-30LANSOPRAZOLE30 in 1 BOTTLECAPSULE, DELAYED RELEASE305
61919-245-60LANSOPRAZOLE60 in 1 BOTTLECAPSULE, DELAYED RELEASE605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-245-30EA - Each61919-245550d363e-2cad-4b16-8c4e-ff2ae163a78a12015-08-04
61919-245-60EA - Each61919-2451d0bb0b7-b901-4f33-b0e4-7d558c8461d712019-12-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
lansoprazoleACTIVE INGREDIENT0K5C5T2QPGLANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]1
LANSOPRAZOLEACTIVE MOIETY0K5C5T2QPGLANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]1
ammoniaINACTIVE INGREDIENT5138Q19F1XLANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]1
ferric oxide redINACTIVE INGREDIENT1K09F3G675LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]1
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTLANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]1
gelatinINACTIVE INGREDIENT2G86QN327LLANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]1
Hydroxypropyl Cellulose (Type H)INACTIVE INGREDIENTRFW2ET671PLANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]1
hydroxypropyl cellulose, low substitutedINACTIVE INGREDIENT2165RE0K14LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]1
magnesium carbonateINACTIVE INGREDIENT0E53J927NALANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]1
methacrylic acid - ethyl acrylate copolymer (1:1) Type AINACTIVE INGREDIENTNX76LV5T8JLANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]1
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1ALANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]1
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HLANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]1
raw sugarINACTIVE INGREDIENT8M707QY5GHLANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]1
shellacINACTIVE INGREDIENT46N107B71OLANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]1
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JLANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]1
starch, cornINACTIVE INGREDIENTO8232NY3SJLANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]1
sucroseINACTIVE INGREDIENTC151H8M554LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]1
talcINACTIVE INGREDIENT7SEV7J4R1ULANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPLANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-245LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]5Legacy NDC, 2 package rows20191126_e55d3f85-a6f2-42ff-a83d-645743c7cc6b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596843lansoprazole 15 MG Delayed Release Oral CapsulePSNe55d3f85-a6f2-42ff-a83d-645743c7cc6b5
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCDe55d3f85-a6f2-42ff-a83d-645743c7cc6b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-245-306191902453030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (61919-245-30) 2014-01-010000-00-00NoNoCurrent
61919-245-606191902456060 CAPSULE, DELAYED RELEASE in 1 BOTTLE (61919-245-60) 2014-01-010000-00-00NoNoCurrent