FDA.reportPublic FDA data

Loratadine

Product NDC
21130-526
11-digit product format
211300526
Labeler code
21130
Product ID
21130-526_5ef0c05a-40de-40cb-b52c-3f1ab96a5348
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
SAFEWAY INC.
Application
ANDA076134
Marketing category
ANDA
Marketing start
2009-06-06
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
21130-526-13Loratadine120 in 1 BOTTLETABLET1204
21130-526-13Loratadine1 in 1 CARTONTABLET14
21130-526-31Loratadine3 in 1 CARTONTABLET34
21130-526-31Loratadine10 in 1 BLISTER PACKTABLET104
21130-526-38Loratadine1 in 1 CARTONTABLET14
21130-526-38Loratadine365 in 1 BOTTLETABLET3654
21130-526-43Loratadine45 in 1 BOTTLETABLET454
21130-526-43Loratadine1 in 1 CARTONTABLET14
21130-526-69Loratadine10 in 1 BLISTER PACKTABLET104
21130-526-69Loratadine1 in 1 CARTONTABLET14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LORATADINEACTIVE INGREDIENT7AJO3BO7QNLORATADINE TABLET [SAFEWAY INC.]1
LORATADINEACTIVE MOIETY7AJO3BO7QNLORATADINE TABLET [SAFEWAY INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLORATADINE TABLET [SAFEWAY INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LORATADINE TABLET [SAFEWAY INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLORATADINE TABLET [SAFEWAY INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-526LORATADINE TABLET [SAFEWAY INC.]4Current NDC, Legacy NDC, 10 package rows20211221_1092b8af-25f2-4c25-b3bc-5ffb14e96024.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSN1092b8af-25f2-4c25-b3bc-5ffb14e960244
311372loratadine 10 MG Oral TabletSCD1092b8af-25f2-4c25-b3bc-5ffb14e960244
311372loratadine 10 MG 24 HR Oral TabletSY1092b8af-25f2-4c25-b3bc-5ffb14e960244

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21130-526-13211300526131 BOTTLE in 1 CARTON (21130-526-13) / 120 TABLET in 1 BOTTLE1 bottle2009-06-060000-00-00NoNoCurrent
21130-526-31211300526313 BLISTER PACK in 1 CARTON (21130-526-31) / 10 TABLET in 1 BLISTER PACK3 blister pack2009-06-060000-00-00NoNoCurrent
21130-526-38211300526381 BOTTLE in 1 CARTON (21130-526-38) / 365 TABLET in 1 BOTTLE1 bottle2009-06-060000-00-00NoNoCurrent
21130-526-43211300526431 BOTTLE in 1 CARTON (21130-526-43) / 45 TABLET in 1 BOTTLE1 bottle2009-06-060000-00-00NoNoCurrent
21130-526-69211300526691 BLISTER PACK in 1 CARTON (21130-526-69) / 10 TABLET in 1 BLISTER PACK1 blister pack2009-06-060000-00-00NoNoCurrent