Loratadine

Product NDC
51079-246
11-digit product format
510790246
Labeler code
51079
Product ID
51079-246_3a865b90-4189-3e83-e063-6394a90aba53
Type
HUMAN OTC DRUG
Nonproprietary name
loratadine
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Institutional Inc.
Application
ANDA076154
Marketing category
ANDA
Marketing start
2013-04-30
Substance
LORATADINE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Loratadine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORATADINE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7AJO3BO7QN
Rxcui311372

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51079-246-01Loratadine1 in 1 BLISTER PACKTABLET111
51079-246-20Loratadine100 in 1 BOX, UNIT-DOSETABLET10011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51079-246-01EA - Each51079-246adff317d-19f8-443c-9a3c-2aaa0c60c9f612013-06-04
51079-246-20EA - Each51079-246ee862795-d632-44eb-96af-f9374f529e9712013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LORATADINEACTIVE INGREDIENT7AJO3BO7QNLORATADINE TABLET [MYLAN INSTITUTIONAL INC.]3
LORATADINEACTIVE MOIETY7AJO3BO7QNLORATADINE TABLET [MYLAN INSTITUTIONAL INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLORATADINE TABLET [MYLAN INSTITUTIONAL INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LORATADINE TABLET [MYLAN INSTITUTIONAL INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLORATADINE TABLET [MYLAN INSTITUTIONAL INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51079-246LORATADINE TABLET [MYLAN INSTITUTIONAL INC.]10Current NDC, Legacy NDC, 2 package rows20240927_1fc9ddd1-393d-4fe2-a9e0-d192df7331db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSN1fc9ddd1-393d-4fe2-a9e0-d192df7331db11
311372loratadine 10 MG Oral TabletSCD1fc9ddd1-393d-4fe2-a9e0-d192df7331db11
311372loratadine 10 MG 24 HR Oral TabletSY1fc9ddd1-393d-4fe2-a9e0-d192df7331db11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51079-246-01510790246011 in 1 BLISTER PACKHistorical
51079-246-2051079024620100 BLISTER PACK in 1 BOX, UNIT-DOSE (51079-246-20) / 1 TABLET in 1 BLISTER PACK (51079-246-01) 100 blister pack2013-04-302030-01-31NoNoCurrent