FDA.reportPublic FDA data

LORATADINE

Product NDC
51316-503
11-digit product format
513160503
Labeler code
51316
Product ID
51316-503_0df114fa-ae43-e77d-e063-6294a90a8c36
Type
HUMAN OTC DRUG
Nonproprietary name
LORATADINE
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
CVS PHARMACY, INC
Application
ANDA213294
Marketing category
ANDA
Marketing start
2021-08-08
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
Rxcui311373

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51316-503-012023-02-09C16284748780-1f386c64a-288c-0266-e053-dadaa90a7c1aLoratidine Orally Disintegrating Tablets, USP
51316-503-022023-02-09C16284748780-1f386c64a-288c-0266-e053-dadaa90a7c1aLoratidine Orally Disintegrating Tablets, USP
51316-503-032023-02-09C16284748780-1f386c64a-288c-0266-e053-dadaa90a7c1aLoratidine Orally Disintegrating Tablets, USP
51316-503-042023-02-09C16284748780-1f386c64a-288c-0266-e053-dadaa90a7c1aLoratidine Orally Disintegrating Tablets, USP
51316-503-052023-02-09C16284748780-1f386c64a-288c-0266-e053-dadaa90a7c1aLoratidine Orally Disintegrating Tablets, USP
51316-503-062023-02-09C16284748780-1f386c64a-288c-0266-e053-dadaa90a7c1aLoratidine Orally Disintegrating Tablets, USP
51316-503-012023-01-30C16284748780-1f386c64a-288c-0266-e053-dadaa90a7c1aLoratidine Orally Disintegrating Tablets, USP
51316-503-022023-01-30C16284748780-1f386c64a-288c-0266-e053-dadaa90a7c1aLoratidine Orally Disintegrating Tablets, USP
51316-503-032023-01-30C16284748780-1f386c64a-288c-0266-e053-dadaa90a7c1aLoratidine Orally Disintegrating Tablets, USP
51316-503-042023-01-30C16284748780-1f386c64a-288c-0266-e053-dadaa90a7c1aLoratidine Orally Disintegrating Tablets, USP
51316-503-052023-01-30C16284748780-1f386c64a-288c-0266-e053-dadaa90a7c1aLoratidine Orally Disintegrating Tablets, USP
51316-503-062023-01-30C16284748780-1f386c64a-288c-0266-e053-dadaa90a7c1aLoratidine Orally Disintegrating Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-503-01LORATADINE10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING108
51316-503-01LORATADINE1 in 1 CARTONTABLET, ORALLY DISINTEGRATING18
51316-503-02LORATADINE20 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING208
51316-503-02LORATADINE2 in 1 CARTONTABLET, ORALLY DISINTEGRATING28
51316-503-03LORATADINE3 in 1 CARTONTABLET, ORALLY DISINTEGRATING38
51316-503-03LORATADINE30 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING308
51316-503-04LORATADINE40 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING408
51316-503-04LORATADINE4 in 1 CARTONTABLET, ORALLY DISINTEGRATING48
51316-503-05LORATADINE50 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING508
51316-503-05LORATADINE5 in 1 CARTONTABLET, ORALLY DISINTEGRATING58
51316-503-06LORATADINE6 in 1 CARTONTABLET, ORALLY DISINTEGRATING68
51316-503-06LORATADINE60 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING608

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-503LORATADINE TABLET, ORALLY DISINTEGRATING [CVS PHARMACY, INC]8Current NDC, Legacy NDC, 12 package rows20240102_7ed2aec0-4da7-4edc-9998-b96c67c82738.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311373loratadine 10 MG 24HR Disintegrating Oral TabletPSN7ed2aec0-4da7-4edc-9998-b96c67c827388
311373loratadine 10 MG Disintegrating Oral TabletSCD7ed2aec0-4da7-4edc-9998-b96c67c827388

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51316-503-01513160503011 BLISTER PACK in 1 CARTON (51316-503-01) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK1 blister pack2021-08-080000-00-00NoNoCurrent
51316-503-02513160503022 BLISTER PACK in 1 CARTON (51316-503-02) / 20 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK2 blister pack2021-08-080000-00-00NoNoCurrent
51316-503-03513160503033 BLISTER PACK in 1 CARTON (51316-503-03) / 30 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK3 blister pack2021-08-080000-00-00NoNoCurrent
51316-503-04513160503044 BLISTER PACK in 1 CARTON (51316-503-04) / 40 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK4 blister pack2021-08-080000-00-00NoNoCurrent
51316-503-05513160503055 BLISTER PACK in 1 CARTON (51316-503-05) / 50 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK5 blister pack2021-08-080000-00-00NoNoCurrent
51316-503-06513160503066 BLISTER PACK in 1 CARTON (51316-503-06) / 60 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK6 blister pack2021-08-080000-00-00NoNoCurrent