FDA.reportPublic FDA data

Desloratadine

Product NDC
62250-619
11-digit product format
622500619
Labeler code
62250
Product ID
62250-619_efd1035a-228c-69c7-e053-2995a90ac3f4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desloratadine
Dosage form
TABLET
Route
ORAL
Labeler
Belcher Pharmaceuticals,LLC
Application
ANDA078355
Marketing category
ANDA
Marketing start
2012-05-15
Marketing end
0000-00-00
Substance
DESLORATADINE
Active strength
5 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
01632a31-f1c5-44ea-aa59-efded68c0797Product name120150716
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
c6d3c427-3d3d-6bcf-7aa8-536d42cf1fd8Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62250-619-012025-07-29C16284748780-13b156c62-2afe-fb37-e063-e6dba90a4e07Desloratadine Tablets These highlights do not include all the information needed to use Desloratadine safely and effectively. See full prescribing information for Desloratadine. Desloratadine (Desloratadine) TABLET for ORAL use. Initial U.S. Approval: 2001
62250-619-022025-07-29C16284748780-13b156c62-2afe-fb37-e063-e6dba90a4e07Desloratadine Tablets These highlights do not include all the information needed to use Desloratadine safely and effectively. See full prescribing information for Desloratadine. Desloratadine (Desloratadine) TABLET for ORAL use. Initial U.S. Approval: 2001
62250-619-082025-07-29C16284748780-13b156c62-2afe-fb37-e063-e6dba90a4e07Desloratadine Tablets These highlights do not include all the information needed to use Desloratadine safely and effectively. See full prescribing information for Desloratadine. Desloratadine (Desloratadine) TABLET for ORAL use. Initial U.S. Approval: 2001

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62250-619-01Desloratadine30 in 1 BOTTLETABLET3012
62250-619-02Desloratadine100 in 1 BOTTLETABLET10012
62250-619-08Desloratadine500 in 1 BOTTLETABLET50012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62250-619-02EA - Each62250-619fba87a80-61a3-46ba-bd35-75438edf5fa212014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DESLORATADINEACTIVE INGREDIENTFVF865388RDESLORATADINE TABLET [BELCHER PHARMACEUTICALS,LLC]3
DESLORATADINEACTIVE MOIETYFVF865388RDESLORATADINE TABLET [BELCHER PHARMACEUTICALS,LLC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDESLORATADINE TABLET [BELCHER PHARMACEUTICALS,LLC]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48DESLORATADINE TABLET [BELCHER PHARMACEUTICALS,LLC]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDESLORATADINE TABLET [BELCHER PHARMACEUTICALS,LLC]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDESLORATADINE TABLET [BELCHER PHARMACEUTICALS,LLC]3
TALCINACTIVE INGREDIENT7SEV7J4R1UDESLORATADINE TABLET [BELCHER PHARMACEUTICALS,LLC]3
ZINC STEARATEINACTIVE INGREDIENTH92E6QA4FVDESLORATADINE TABLET [BELCHER PHARMACEUTICALS,LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62250-619DESLORATADINE TABLET [BELCHER PHARMACEUTICALS,LLC]12Legacy NDC, 3 package rows20231006_dbb8e695-f00b-4c67-bd49-09a1ae5bb669.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349420desloratadine 5 MG Oral TabletPSNdbb8e695-f00b-4c67-bd49-09a1ae5bb66912
349420desloratadine 5 MG Oral TabletSCDdbb8e695-f00b-4c67-bd49-09a1ae5bb66912

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62250-619-016225006190130 TABLET in 1 BOTTLE (62250-619-01) 30 tablet2012-12-280000-00-00NoNoCurrent
62250-619-0262250061902100 TABLET in 1 BOTTLE (62250-619-02) 100 tablet2012-12-280000-00-00NoNoCurrent
62250-619-0862250061908500 TABLET in 1 BOTTLE (62250-619-08) 500 tablet2018-12-280000-00-00NoNoCurrent