FDA.reportPublic FDA data

good sense allergy relief

Product NDC
50090-7048
11-digit product format
500907048
Labeler code
50090
Product ID
50090-7048_ffff8b1f-8cb7-4fa3-a795-6b749d09942e
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA076301
Marketing category
ANDA
Marketing start
2004-09-21
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
good sense allergy relief
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
50090-7048-0good sense allergy relief10 in 1 BOTTLETABLET103
50090-7048-4good sense allergy relief30 in 1 BOTTLETABLET303
50090-7048-4good sense allergy relief1 in 1 CARTONTABLET13
50090-7048-5good sense allergy relief90 in 1 BOTTLETABLET903
50090-7048-5good sense allergy relief1 in 1 CARTONTABLET13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7048-0EA - Each50090-7048f04093c9-25ef-43df-81a7-b830f0bcae7212024-05-16
50090-7048-4EA - Each50090-7048d3153e83-bbdb-468b-8028-5a07889f3dcc12024-05-16
50090-7048-5EA - Each50090-7048b0c8c1c5-110b-4681-8114-e5dc720dc4cf12024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7048GOOD SENSE ALLERGY RELIEF (LORATADINE) TABLET [A-S MEDICATION SOLUTIONS]3Current NDC, 5 package rows20240329_c288d849-59c9-4883-aac4-bae54acee8ac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311372loratadine 10 MG 24HR Oral TabletPSNc288d849-59c9-4883-aac4-bae54acee8ac3
311372loratadine 10 MG Oral TabletSCDc288d849-59c9-4883-aac4-bae54acee8ac3
311372loratadine 10 MG 24 HR Oral TabletSYc288d849-59c9-4883-aac4-bae54acee8ac3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7048-05009070480010 TABLET in 1 BOTTLE (50090-7048-0) 10 tablet2024-01-15NoNoHistorical
50090-7048-4500907048041 BOTTLE in 1 CARTON (50090-7048-4) / 30 TABLET in 1 BOTTLE1 bottle2024-01-15NoNoHistorical
50090-7048-5500907048051 BOTTLE in 1 CARTON (50090-7048-5) / 90 TABLET in 1 BOTTLE1 bottle2024-01-15NoNoHistorical