Childrens Loratadine Oral

Product NDC
17856-6767
11-digit product format
178566767
Labeler code
17856
Product ID
17856-6767_4a1a6858-a837-261e-e063-6394a90a3923
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
SOLUTION
Route
ORAL
Labeler
Atlantic Biologicals
Application
ANDA075728
Marketing category
ANDA
Marketing start
2019-02-12
Substance
LORATADINE
Active strength
5 mg/5mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Childrens Loratadine Oral
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORATADINE5 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7AJO3BO7QN
Rxcui692783

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-6767-1Childrens Loratadine Oral72 in 1 CASESOLUTION721
17856-6767-1Childrens Loratadine Oral5 mL in 1 CUP, UNIT-DOSESOLUTION51

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
692783loratadine 5 MG in 5 mL Oral SolutionPSN4a1a6981-133c-d45b-e063-6294a90a4a091
692783loratadine 1 MG/ML Oral SolutionSCD4a1a6981-133c-d45b-e063-6294a90a4a091
692783loratadine 5 MG per 5 ML Oral SolutionSY4a1a6981-133c-d45b-e063-6294a90a4a091

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
17856-6767-11785667670172 CUP, UNIT-DOSE in 1 CASE (17856-6767-1) / 5 mL in 1 CUP, UNIT-DOSE2026-02-05NoNoHistorical