Loratadine

Product NDC
69230-322
11-digit product format
692300322
Labeler code
69230
Product ID
69230-322_4f169a54-c021-23db-e063-6294a90a422e
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
SOLUTION
Route
ORAL
Labeler
Camber Consumer Care Inc
Application
ANDA210409
Marketing category
ANDA
Marketing start
2021-05-07
Substance
LORATADINE
Active strength
5 mg/5mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Loratadine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORATADINE5 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7AJO3BO7QN
Rxcui692783

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69230-322-12Loratadine1 in 1 CARTONSOLUTION12
69230-322-12Loratadine120 mL in 1 BOTTLESOLUTION1202
69230-322-24Loratadine240 mL in 1 BOTTLESOLUTION2402
69230-322-24Loratadine1 in 1 CARTONSOLUTION12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69230-322-12ML - Milliliter69230-32259566099-159a-4c72-9444-88d5eba3b2b912021-11-09
69230-322-24ML - Milliliter69230-3225cc969d4-5d89-4fc0-ae5e-55c3a6f3db4d12021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69230-322LORATADINE (LORATADINE) SOLUTION [CAMBER CONSUMER CARE INC]1Current NDC, Legacy NDC, 4 package rows20210529_4dec6d48-78e0-48a4-9274-25f6cbf26a2c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
692783loratadine 5 MG in 5 mL Oral SolutionPSN4dec6d48-78e0-48a4-9274-25f6cbf26a2c2
692783loratadine 1 MG/ML Oral SolutionSCD4dec6d48-78e0-48a4-9274-25f6cbf26a2c2
692783loratadine 5 MG per 5 ML Oral SolutionSY4dec6d48-78e0-48a4-9274-25f6cbf26a2c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69230-322-12692300322121 BOTTLE in 1 CARTON (69230-322-12) / 120 mL in 1 BOTTLE1 bottle2021-05-070000-00-00NoNoCurrent
69230-322-24692300322241 BOTTLE in 1 CARTON (69230-322-24) / 240 mL in 1 BOTTLE1 bottle2021-05-070000-00-00NoNoCurrent