CABERGOLINE

Product NDC
70069-824
11-digit product format
700690824
Labeler code
70069
Product ID
70069-824_999ea838-e592-4769-a702-68d934de3e1d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CABERGOLINE
Dosage form
TABLET
Route
ORAL
Labeler
Somerset Therapeutics, LLC
Application
ANDA218109
Marketing category
ANDA
Marketing start
2024-10-18
Substance
CABERGOLINE
Active strength
.5 mg/1
Pharmacologic classes
Ergolines [CS], Ergot Derivative [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CABERGOLINE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CABERGOLINE.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiLL60K9J05T
Rxcui199703

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
130aac29-e6c6-4d4b-17f4-126c01ca97cfProduct name320250304

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70069-824-08CABERGOLINE8 in 1 BOTTLETABLET84

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70069-824-08EA - Each70069-82432101eac-7779-4de3-81ae-930c05763c1d12024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70069-824CABERGOLINE TABLET [SOMERSET THERAPEUTICS, LLC]4Current NDC, 1 package rows20241116_e0fb5556-de2c-4822-9960-0700e2907890.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199703cabergoline 0.5 MG Oral TabletPSNe0fb5556-de2c-4822-9960-0700e29078904
199703cabergoline 0.5 MG Oral TabletSCDe0fb5556-de2c-4822-9960-0700e29078904

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70069-824-08700690824088 TABLET in 1 BOTTLE (70069-824-08) 8 tablet2024-10-18NoNoCurrent