LORATADINE

Product NDC
69230-328
11-digit product format
692300328
Labeler code
69230
Product ID
69230-328_ef239f47-2514-8b93-e053-2a95a90a4b71
Type
HUMAN OTC DRUG
Nonproprietary name
LORATADINE
Dosage form
TABLET
Route
ORAL
Labeler
Camber Consumer Care Inc
Application
ANDA210722
Marketing category
ANDA
Marketing start
2022-07-31
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
69230-328-01LORATADINE100 in 1 BOTTLETABLET1002
69230-328-01LORATADINE1 in 1 CARTONTABLET12
69230-328-03LORATADINE300 in 1 BOTTLETABLET3002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69230-328-01EA - Each69230-328f9c7a71e-e962-4f5c-9b02-18cd124e24c412022-12-07
69230-328-03EA - Each69230-328bbad58fa-1a32-4fef-9309-6e1bc1e8245512022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69230-328LORATADINE (LORATADINE) TABLET [CAMBER CONSUMER CARE INC]2Current NDC, Legacy NDC, 3 package rows20221207_1e92f77f-d4ba-4f34-96f9-daf878b4ea6a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSNf98ebe1f-c3cc-ce98-e053-6394a90aeb0b3
311372loratadine 10 MG Oral TabletSCDf98ebe1f-c3cc-ce98-e053-6394a90aeb0b3
311372loratadine 10 MG 24 HR Oral TabletSYf98ebe1f-c3cc-ce98-e053-6394a90aeb0b3
311372loratadine 10 MG 24HR Oral TabletPSN1e92f77f-d4ba-4f34-96f9-daf878b4ea6a2
311372loratadine 10 MG Oral TabletSCD1e92f77f-d4ba-4f34-96f9-daf878b4ea6a2
311372loratadine 10 MG 24 HR Oral TabletSY1e92f77f-d4ba-4f34-96f9-daf878b4ea6a2
311372loratadine 10 MG 24HR Oral TabletPSN0cca8170-dd10-3840-e063-6394a90ab2431
311372loratadine 10 MG Oral TabletSCD0cca8170-dd10-3840-e063-6394a90ab2431
311372loratadine 10 MG 24 HR Oral TabletSY0cca8170-dd10-3840-e063-6394a90ab2431

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69230-328-01692300328011 BOTTLE in 1 CARTON (69230-328-01) / 100 TABLET in 1 BOTTLE1 bottle2022-07-310000-00-00NoNoCurrent
69230-328-0369230032803300 TABLET in 1 BOTTLE (69230-328-03) 300 tablet2022-07-310000-00-00NoNoCurrent