Dye-Free Childrens Loratadine

Product NDC
51660-112
11-digit product format
516600112
Labeler code
51660
Product ID
51660-112_10b4bbcb-dcd3-acc9-e063-6394a90a5daf
Type
HUMAN OTC DRUG
Nonproprietary name
LORATADINE
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Ohm Laboratories Inc.
Application
ANDA210088
Marketing category
ANDA
Marketing start
2020-08-19
Substance
LORATADINE
Active strength
5 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
Dye-Free Childrens Loratadine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORATADINE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7AJO3BO7QN
Rxcui665078

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51660-112-31Dye-Free Childrens Loratadine10 in 1 BLISTER PACKTABLET, CHEWABLE103
51660-112-31Dye-Free Childrens Loratadine3 in 1 CARTONTABLET, CHEWABLE33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51660-112DYE-FREE CHILDRENS LORATADINE (LORATADINE) TABLET, CHEWABLE [OHM LABORATORIES INC.]3Current NDC, Legacy NDC, 2 package rows20240315_9e9b2e1c-f565-42ef-9ec4-43bcebc549b7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
665078loratadine 5 MG 24HR Chewable TabletPSN9e9b2e1c-f565-42ef-9ec4-43bcebc549b73
665078loratadine 5 MG Chewable TabletSCD9e9b2e1c-f565-42ef-9ec4-43bcebc549b73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51660-112-31516600112313 BLISTER PACK in 1 CARTON (51660-112-31) / 10 TABLET, CHEWABLE in 1 BLISTER PACK3 blister pack2020-08-190000-00-00NoNoCurrent