Loratadine

Product NDC
82725-0142
11-digit product format
827250142
Labeler code
82725
Product ID
82725-0142_42292076-863b-8cc2-e063-6294a90ae709
Type
HUMAN OTC DRUG
Nonproprietary name
LORATADINE
Dosage form
TABLET
Route
ORAL
Labeler
Cabinet Health P.B.C.
Application
ANDA214684
Marketing category
ANDA
Marketing start
2025-10-01
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
82725-0142-1Loratadine8000 in 1 BAGTABLET80001
82725-0142-2Loratadine100000 in 1 BAGTABLET1000001
82725-0142-2Loratadine1 in 1 DRUMTABLET11
82725-0142-3Loratadine10000 in 1 BAGTABLET100001
82725-0142-4Loratadine96000 in 1 DRUMTABLET960001
82725-0142-4Loratadine1 in 1 DRUMTABLET11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSN8b090fa2-9535-456c-b14d-187a2873cdf71
311372loratadine 10 MG Oral TabletSCD8b090fa2-9535-456c-b14d-187a2873cdf71
311372loratadine 10 MG 24 HR Oral TabletSY8b090fa2-9535-456c-b14d-187a2873cdf71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82725-0142-1827250142018000 TABLET in 1 BAG (82725-0142-1) 8000 tablet2025-10-01NoNoCurrent
82725-0142-2827250142021 BAG in 1 DRUM (82725-0142-2) / 100000 TABLET in 1 BAG1 bag2025-10-01NoNoCurrent
82725-0142-38272501420310000 TABLET in 1 BAG (82725-0142-3) 10000 tablet2025-10-01NoNoCurrent
82725-0142-4827250142041 DRUM in 1 DRUM (82725-0142-4) / 96000 TABLET in 1 DRUM1 drum2025-10-01NoNoCurrent