FDA.reportPublic FDA data

Loratadine

Product NDC
10544-455
11-digit product format
105440455
Labeler code
10544
Product ID
10544-455_0fc465dc-f0d9-06dc-e054-00144ff8d46c
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA076471
Marketing category
ANDA
Marketing start
2014-02-09
Marketing end
0000-00-00
Substance
LORATADINE
Active strength
10 mg/1
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10544-455-302020-01-31C16284748780-19d75b9d0-597a-f424-e053-dadaa90a57ceLoratadine Tablet 10 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-455-30Loratadine30 in 1 BOTTLETABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-455-30EA - Each10544-4551204894b-9f3f-4ec6-8730-5ef0bf0c262a12015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LORATADINEACTIVE INGREDIENT7AJO3BO7QNLORATADINE TABLET [BLENHEIM PHARMACAL, INC.]1
LORATADINEACTIVE MOIETY7AJO3BO7QNLORATADINE TABLET [BLENHEIM PHARMACAL, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULORATADINE TABLET [BLENHEIM PHARMACAL, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LORATADINE TABLET [BLENHEIM PHARMACAL, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLORATADINE TABLET [BLENHEIM PHARMACAL, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LORATADINE TABLET [BLENHEIM PHARMACAL, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LORATADINE TABLET [BLENHEIM PHARMACAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-455LORATADINE TABLET [BLENHEIM PHARMACAL, INC.]1Legacy NDC, 1 package rows20150223_0fc465dc-f0d8-06dc-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSN0fc465dc-f0d8-06dc-e054-00144ff8d46c1
311372loratadine 10 MG Oral TabletSCD0fc465dc-f0d8-06dc-e054-00144ff8d46c1
311372loratadine 10 MG 24 HR Oral TabletSY0fc465dc-f0d8-06dc-e054-00144ff8d46c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-455-301054404553030 in 1 BOTTLEHistorical