Loratadine

Product NDC
63941-526
11-digit product format
639410526
Labeler code
63941
Product ID
63941-526_bc05aca7-4224-4b42-93b7-d28fbf18c0b1
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
Valu Merchandisers Company
Application
ANDA076134
Marketing category
ANDA
Marketing start
2003-08-19
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
63941-526-31Loratadine30 in 1 BLISTER PACKTABLET302
63941-526-60Loratadine60 in 1 BOTTLETABLET602
63941-526-69Loratadine10 in 1 BLISTER PACKTABLET102

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LORATADINEACTIVE INGREDIENT7AJO3BO7QNLORATADINE TABLET [VALU MERCHANDISERS COMPANY]1
LORATADINEACTIVE MOIETY7AJO3BO7QNLORATADINE TABLET [VALU MERCHANDISERS COMPANY]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLORATADINE TABLET [VALU MERCHANDISERS COMPANY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LORATADINE TABLET [VALU MERCHANDISERS COMPANY]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLORATADINE TABLET [VALU MERCHANDISERS COMPANY]1
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJLORATADINE TABLET [VALU MERCHANDISERS COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63941-526LORATADINE TABLET [VALU MERCHANDISERS COMPANY]2Current NDC, Legacy NDC, 3 package rows20180829_0cd920b4-b15a-4ca9-87e2-4dd523c6d1f8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSN0cd920b4-b15a-4ca9-87e2-4dd523c6d1f82
311372loratadine 10 MG Oral TabletSCD0cd920b4-b15a-4ca9-87e2-4dd523c6d1f82
311372loratadine 10 MG 24 HR Oral TabletSY0cd920b4-b15a-4ca9-87e2-4dd523c6d1f82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63941-526-316394105263130 TABLET in 1 BLISTER PACK (63941-526-31) 30 tablet2003-08-190000-00-00NoNoCurrent
63941-526-606394105266060 TABLET in 1 BOTTLE (63941-526-60) 60 tablet2003-08-190000-00-00NoNoCurrent
63941-526-696394105266910 TABLET in 1 BLISTER PACK (63941-526-69) 10 tablet2003-08-190000-00-00NoNoCurrent