Cabergoline

Product NDC
69238-2693
11-digit product format
692382693
Labeler code
69238
Product ID
69238-2693_3e2ff3e8-fa09-469e-b545-68ab6b168de7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cabergoline
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA218618
Marketing category
ANDA
Marketing start
2024-10-03
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
69238-2693-1Cabergoline8 in 1 BOTTLETABLET81

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-2693-1EA - Each69238-2693bfd578bb-77ac-448d-9efc-157288a548d812025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-2693CABERGOLINE TABLET [AMNEAL PHARMACEUTICALS NY LLC]1Current NDC, 1 package rows20241004_a246b015-e19c-4b4f-9089-aea1108687ba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199703cabergoline 0.5 MG Oral TabletPSN9405c116-4a77-4e14-9ab8-25e899595cdf1
199703cabergoline 0.5 MG Oral TabletPSNa246b015-e19c-4b4f-9089-aea1108687ba1
199703cabergoline 0.5 MG Oral TabletSCD9405c116-4a77-4e14-9ab8-25e899595cdf1
199703cabergoline 0.5 MG Oral TabletSCDa246b015-e19c-4b4f-9089-aea1108687ba1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69238-2693-1692382693018 TABLET in 1 BOTTLE (69238-2693-1) 8 tablet2024-10-03NoNoHistorical