Sunmark

Product NDC
49348-636
11-digit product format
493480636
Labeler code
49348
Product ID
49348-636_29a2cbbe-88da-1498-e063-6394a90ac36c
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
SOLUTION
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
ANDA076805
Marketing category
ANDA
Marketing start
2004-08-20
Substance
LORATADINE
Active strength
5 mg/5mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sunmark
Brand name suffix
childrens loratadine
Listing expiration
2026-12-31

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
49348-636-34Sunmark childrens loratadine120 mL in 1 BOTTLESOLUTION1203
49348-636-34Sunmark childrens loratadine1 in 1 CARTONSOLUTION13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-636-34ML - Milliliter49348-636334abf37-de89-426b-8c08-54950b51548412013-02-13

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49348-636SUNMARK CHILDRENS LORATADINE (LORATADINE) SOLUTION [STRATEGIC SOURCING SERVICES LLC]3Current NDC, Legacy NDC, 2 package rows20241222_ed94cba7-c2c4-4cbe-9021-f554a51d51f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
692783loratadine 5 MG in 5 mL Oral SolutionPSNed94cba7-c2c4-4cbe-9021-f554a51d51f23
692783loratadine 1 MG/ML Oral SolutionSCDed94cba7-c2c4-4cbe-9021-f554a51d51f23
692783loratadine 5 MG per 5 ML Oral SolutionSYed94cba7-c2c4-4cbe-9021-f554a51d51f23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49348-636-34493480636341 BOTTLE in 1 CARTON (49348-636-34) / 120 mL in 1 BOTTLE1 bottle2012-11-140000-00-00NoNoCurrent