FDA.reportPublic FDA data

LORATADINE

Product NDC
69452-211
11-digit product format
694520211
Labeler code
69452
Product ID
69452-211_932678d1-e6bf-4154-ac00-b6b9c9fbd16e
Type
HUMAN OTC DRUG
Nonproprietary name
LORATADINE
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Bionpharma Inc.
Application
ANDA202538
Marketing category
ANDA
Marketing start
2019-03-01
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
Rxcui828269

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69452-211-03LORATADINE5 in 1 BOTTLECAPSULE, LIQUID FILLED52
69452-211-03LORATADINE1 in 1 CARTONCAPSULE, LIQUID FILLED12
69452-211-07LORATADINE10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED102
69452-211-07LORATADINE1 in 1 CARTONCAPSULE, LIQUID FILLED12
69452-211-16LORATADINE50 in 1 BOTTLECAPSULE, LIQUID FILLED502
69452-211-16LORATADINE1 in 1 CARTONCAPSULE, LIQUID FILLED12
69452-211-26LORATADINE200 in 1 BOTTLECAPSULE, LIQUID FILLED2002
69452-211-26LORATADINE1 in 1 CARTONCAPSULE, LIQUID FILLED12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69452-211LORATADINE CAPSULE, LIQUID FILLED [BIONPHARMA INC.]2Current NDC, Legacy NDC, 8 package rows20190301_59bebce3-2b82-4521-a796-2d4c83bcf669.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828269loratadine 10 MG 24HR Oral CapsulePSN59bebce3-2b82-4521-a796-2d4c83bcf6692
828269loratadine 10 MG Oral CapsuleSCD59bebce3-2b82-4521-a796-2d4c83bcf6692
828269loratadine 10 MG 24HR Oral CapsuleSY59bebce3-2b82-4521-a796-2d4c83bcf6692

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69452-211-03694520211031 BOTTLE in 1 CARTON (69452-211-03) / 5 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2019-03-010000-00-00NoNoCurrent
69452-211-07694520211071 BLISTER PACK in 1 CARTON (69452-211-07) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK1 blister pack2019-03-010000-00-00NoNoCurrent
69452-211-16694520211161 BOTTLE in 1 CARTON (69452-211-16) / 50 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2019-03-010000-00-00NoNoCurrent
69452-211-26694520211261 BOTTLE in 1 CARTON (69452-211-26) / 200 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2019-03-010000-00-00NoNoCurrent