DYE-FREE LORATADINE

Product NDC
51660-755
11-digit product format
516600755
Labeler code
51660
Product ID
51660-755_51156462-921d-facf-e063-6294a90a89fe
Type
HUMAN OTC DRUG
Nonproprietary name
LORATADINE
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Ohm Laboratories Inc.
Application
ANDA210088
Marketing category
ANDA
Marketing start
2025-12-02
Substance
LORATADINE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DYE-FREE LORATADINE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORATADINE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7AJO3BO7QN
Rxcui2265266

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51660-755-02DYE-FREE LORATADINE8 in 1 BLISTER PACKTABLET, CHEWABLE82
51660-755-02DYE-FREE LORATADINE3 in 1 CARTONTABLET, CHEWABLE32
51660-755-03DYE-FREE LORATADINE8 in 1 BLISTER PACKTABLET, CHEWABLE82
51660-755-03DYE-FREE LORATADINE6 in 1 CARTONTABLET, CHEWABLE62

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51660-755-02EA - Each51660-755b193283a-6934-4fb8-9ee2-a06688418c7012026-05-22
51660-755-03EA - Each51660-75569c9fecf-5589-449f-a6d0-19c28d9cda6c12026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2265266loratadine 10 MG Chewable TabletPSN48744daa-7079-283d-e063-6394a90a2c9a2
2265266loratadine 10 MG Chewable TabletSCD48744daa-7079-283d-e063-6394a90a2c9a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51660-755-02516600755023 BLISTER PACK in 1 CARTON (51660-755-02) / 8 TABLET, CHEWABLE in 1 BLISTER PACK3 blister pack2025-12-02NoNoCurrent
51660-755-03516600755036 BLISTER PACK in 1 CARTON (51660-755-03) / 8 TABLET, CHEWABLE in 1 BLISTER PACK6 blister pack2025-12-02NoNoCurrent