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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-3157-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-3157-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-3157-0557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50090-3157-08af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50090-3157-0834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50090-3157-01332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077750-001CABERGOLINECABERGOLINE0.5MGTABLET / ORALAB2007-03-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A077750-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077750-001CABERGOLINE0.5MGTABLET / ORALAB2007-03-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077750-001CABERGOLINE0.5MGTABLET / ORALAB2007-03-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A077750-001CABERGOLINE0.5MGTABLET / ORALAB2007-03-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077750-001CABERGOLINE0.5MGTABLET / ORALAB2007-03-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077750-001CABERGOLINE0.5MGTABLET / ORALAB2007-03-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077750-001CABERGOLINE0.5MGTABLET / ORALAB2007-03-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077750-001CABERGOLINE0.5MGTABLET / ORALAB2007-03-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077750-001CABERGOLINE0.5MGTABLET / ORALAB2007-03-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077750-001CABERGOLINE0.5MGTABLET / ORALAB2007-03-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077750-001CABERGOLINE0.5MGTABLET / ORALAB2007-03-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077750-001CABERGOLINE0.5MGTABLET / ORALAB2007-03-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077750-001CABERGOLINE0.5MGTABLET / ORALAB2007-03-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077750-001CABERGOLINE0.5MGTABLET / ORALAB2007-03-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077750-001CABERGOLINE0.5MGTABLET / ORALAB2007-03-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077750-001CABERGOLINE0.5MGTABLET / ORALAB2007-03-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077750-001CABERGOLINE0.5MGTABLET / ORALAB2007-03-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077750-001CABERGOLINE0.5MGTABLET / ORALAB2007-03-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077750-001CABERGOLINE0.5MGTABLET / ORALAB2007-03-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077750-001CABERGOLINE0.5MGTABLET / ORALAB2007-03-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077750-001CABERGOLINE0.5MGTABLET / ORALAB2007-03-07782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077750-001CABERGOLINE0.5MGTABLET / ORALAB2007-03-0787673890dc5c…
2021-03-12 10:30 UTC2021-03A077750-001CABERGOLINE0.5MGTABLET / ORALAB2007-03-075aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077750-001CABERGOLINE0.5MGTABLET / ORALAB2007-03-078869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077750-001CABERGOLINE0.5MGTABLET / ORALAB2007-03-07c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077750-001CABERGOLINE0.5MGTABLET / ORALAB2007-03-073f01610625f2…
2019-09-15 20:21 UTC2019-09A077750-001CABERGOLINE0.5MGTABLET / ORALAB2007-03-07b00525d2431f…
2019-07-19 19:46 UTC2019-07A077750-001CABERGOLINE0.5MGTABLET / ORALAB2007-03-07ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077750-001CABERGOLINE0.5MGTABLET / ORALAB2007-03-076a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077750-001CABERGOLINE0.5MGTABLET / ORALAB2007-03-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077750-001CABERGOLINE0.5MGTABLET / ORALAB2007-03-07ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077750-001CABERGOLINE0.5MGTABLET / ORALAB2007-03-07a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077750-001CABERGOLINE0.5MGTABLET / ORALAB2007-03-079b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077750-001CABERGOLINE0.5MGTABLET / ORALAB2007-03-07a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077750-001CABERGOLINE0.5MGTABLET / ORALAB2007-03-073f0d92c62455…
2023-05-13 08:27 UTC2023-05A077750-001CABERGOLINE0.5MGTABLET / ORALAB2007-03-07053a50430f4f…
2023-01-26 05:58 UTC2023-01A077750-001CABERGOLINE0.5MGTABLET / ORALAB2007-03-073bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077750-001CABERGOLINE0.5MGTABLET / ORALAB2007-03-073a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077750-001CABERGOLINE0.5MGTABLET / ORALAB2007-03-07f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077750-001CABERGOLINE0.5MGTABLET / ORALAB2007-03-07e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A077750-001CABERGOLINE0.5MGTABLET / ORALAB2007-03-07cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A077750-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077750-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077750-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077750-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077750-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077750-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077750-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077750-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077750-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077750-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077750-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077750-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077750-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077750-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077750-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077750-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077750-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077750-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077750-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077750-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077750-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A077750-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077750-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077750-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077750-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A077750-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A077750-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077750-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077750-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077750-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077750-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077750-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077750-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077750-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A077750-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A077750-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077750-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077750-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077750-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A077750-001AB1cb3db0bc1861…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
LL60K9J05TInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
199703Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c9f0b576-d5e5-4e3e-bb5c-3574d75d9907Available on FDA.report

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#

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CabergolineCABERGOLINEA-S Medication Solutionsc9f0b576-d5e5-4e3e-bb5c-3574d75d99072026-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077750
application number: ANDA077750
ndc (product): 50090-3157
CabergolineCABERGOLINETeva Pharmaceuticals USA, Inc.74b61e8a-7ae9-4996-85ec-df23c56de16f2025-06-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077750
application number: ANDA077750

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