Loratadine

Product NDC
63868-151
11-digit product format
638680151
Labeler code
63868
Product ID
63868-151_08f2bf78-eba5-41ce-bcb0-733e2760d44b
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
Chain Drug Marketing Association Inc.
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
63868-151-01Loratadine100 in 1 BOTTLETABLET1002
63868-151-10Loratadine10 in 1 BLISTER PACKTABLET102
63868-151-30Loratadine30 in 1 BLISTER PACKTABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-151-01EA - Each63868-1512c4c2054-3f6a-4480-b142-9b9acb886c8812013-02-13
63868-151-10EA - Each63868-15102979198-ba24-4bde-8e24-cd0fae20aa9a12013-02-13
63868-151-30EA - Each63868-1517a13a994-3214-4a6d-a823-03fb8b4454ba12013-02-13

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-151LORATADINE TABLET [CHAIN DRUG MARKETING ASSOCIATION INC.]2Current NDC, Legacy NDC, 3 package rows20180829_b4edf5b1-398d-405a-8a42-76044b31ebb7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSNb4edf5b1-398d-405a-8a42-76044b31ebb72
311372loratadine 10 MG Oral TabletSCDb4edf5b1-398d-405a-8a42-76044b31ebb72
311372loratadine 10 MG 24 HR Oral TabletSYb4edf5b1-398d-405a-8a42-76044b31ebb72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-151-0163868015101100 TABLET in 1 BOTTLE (63868-151-01) 100 tablet2003-08-190000-00-00NoNoCurrent
63868-151-106386801511010 TABLET in 1 BLISTER PACK (63868-151-10) 10 tablet2003-08-190000-00-00NoNoCurrent
63868-151-306386801513030 TABLET in 1 BLISTER PACK (63868-151-30) 30 tablet2003-08-190000-00-00NoNoCurrent