Childrens Loratadine

Product NDC
70677-1058
11-digit product format
706771058
Labeler code
70677
Product ID
70677-1058_3b2753a7-17e4-fdd7-e063-6294a90afc86
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
SOLUTION
Route
ORAL
Labeler
STRATEGIC SOURCING SERVICES LLC
Application
ANDA076805
Marketing category
ANDA
Marketing start
2023-07-19
Substance
LORATADINE
Active strength
5 mg/5mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Childrens Loratadine
Brand name suffix
Sugar Free
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORATADINE5 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7AJO3BO7QN
Rxcui692783

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70677-1058-12025-07-30C16284748780-13b156c62-27ac-fb37-e063-e6dba90a4e07Loratadine Oral Solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70677-1058-1Childrens Loratadine Sugar Free1 in 1 CARTONSOLUTION12
70677-1058-1Childrens Loratadine Sugar Free120 mL in 1 BOTTLESOLUTION1202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1058-1ML - Milliliter70677-1058ea3f1023-07bb-4f55-994f-21d9e0aa229f12024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1058CHILDRENS LORATADINE SUGAR FREE (LORATADINE) SOLUTION [STRATEGIC SOURCING SERVICES LLC]1Current NDC, 2 package rows20230805_809456dc-1d1c-42a7-b17f-e43dacde927f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
692783loratadine 5 MG in 5 mL Oral SolutionPSN809456dc-1d1c-42a7-b17f-e43dacde927f2
692783loratadine 1 MG/ML Oral SolutionSCD809456dc-1d1c-42a7-b17f-e43dacde927f2
692783loratadine 5 MG per 5 ML Oral SolutionSY809456dc-1d1c-42a7-b17f-e43dacde927f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70677-1058-1706771058011 BOTTLE in 1 CARTON (70677-1058-1) / 120 mL in 1 BOTTLE1 bottle2023-07-19NoNoHistorical