FDA.reportPublic FDA data

Cabergoline

Product NDC
50090-3157
11-digit product format
500903157
Labeler code
50090
Product ID
50090-3157_9cfd8ff7-be0f-4956-b637-63d68606b856
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cabergoline
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA077750
Marketing category
ANDA
Marketing start
2007-03-07
Substance
CABERGOLINE
Active strength
.5 mg/1
Pharmacologic classes
Ergolines [CS], Ergot Derivative [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

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
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-3157-02024-12-19C16284748780-1f386c64a-3787-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CABERGOLINE TABLETS safely and effectively. See full prescribing information for CABERGOLINE TABLETS. CABERGOLINE tablets, for oral use Initial U.S. Approval: 1996
50090-3157-02023-01-30C16284748780-1f386c64a-3787-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CABERGOLINE TABLETS safely and effectively. See full prescribing information for CABERGOLINE TABLETS. CABERGOLINE tablets, for oral use Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3157-0Cabergoline8 in 1 BOTTLETABLET810
50090-3157-0Cabergoline1 in 1 CARTONTABLET110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3157-0EA - Each50090-3157f962b2ee-fd1e-47e1-9697-2726cc3320c812019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3157CABERGOLINE TABLET [A-S MEDICATION SOLUTIONS]8Current NDC, Legacy NDC, 2 package rows20241222_c9f0b576-d5e5-4e3e-bb5c-3574d75d9907.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199703cabergoline 0.5 MG Oral TabletPSNc9f0b576-d5e5-4e3e-bb5c-3574d75d990710
199703cabergoline 0.5 MG Oral TabletSCDc9f0b576-d5e5-4e3e-bb5c-3574d75d990710

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3157-0500903157001 BOTTLE in 1 CARTON (50090-3157-0) / 8 TABLET in 1 BOTTLE1 bottle2017-10-060000-00-00NoNoCurrent