Cabergoline

Product NDC: 59762-1005
11-digit product format: 597621005
Labeler code: 59762
Product ID: 59762-1005_754ad7cd-edf5-4792-890d-07f0e4324c07
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: cabergoline
Dosage form: TABLET
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: NDA020664
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2014-09-22
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

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020664-001	DOSTINEX	CABERGOLINE	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1996-12-23

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020664-001	DOSTINEX	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-12-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020664-001	DOSTINEX	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-12-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020664-001	DOSTINEX	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-12-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020664-001	DOSTINEX	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-12-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020664-001	DOSTINEX	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-12-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020664-001	DOSTINEX	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-12-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020664-001	DOSTINEX	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-12-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020664-001	DOSTINEX	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-12-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020664-001	DOSTINEX	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-12-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020664-001	DOSTINEX	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-12-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020664-001	DOSTINEX	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-12-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020664-001	DOSTINEX	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-12-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020664-001	DOSTINEX	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-12-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020664-001	DOSTINEX	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-12-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020664-001	DOSTINEX	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-12-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020664-001	DOSTINEX	0.5MG	TABLET / ORAL	RLD	1996-12-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020664-001	DOSTINEX	0.5MG	TABLET / ORAL	RLD	1996-12-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020664-001	DOSTINEX	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1996-12-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020664-001	DOSTINEX	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-12-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020664-001	DOSTINEX	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1996-12-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020664-001	DOSTINEX	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1996-12-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020664-001	DOSTINEX	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1996-12-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020664-001	DOSTINEX	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1996-12-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020664-001	DOSTINEX	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1996-12-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020664-001	DOSTINEX	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1996-12-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020664-001	DOSTINEX	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1996-12-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020664-001	DOSTINEX	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1996-12-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020664-001	DOSTINEX	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-12-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020664-001	DOSTINEX	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-12-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020664-001	DOSTINEX	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-12-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020664-001	DOSTINEX	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-12-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020664-001	DOSTINEX	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-12-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020664-001	DOSTINEX	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-12-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020664-001	DOSTINEX	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-12-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020664-001	DOSTINEX	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-12-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020664-001	DOSTINEX	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-12-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020664-001	DOSTINEX	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-12-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020664-001	DOSTINEX	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-12-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020664-001	DOSTINEX	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-12-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020664-001	DOSTINEX	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1996-12-23	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CABERGOLINE	.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
LL60K9J05T	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
e497366b-a124-4d7f-bd45-a883c392d4bb	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
130aac29-e6c6-4d4b-17f4-126c01ca97cf	Product name	3	20250304
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59762-1005-1	Cabergoline	8 in 1 BOTTLE	TABLET	8		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59762-1005-1	EA - Each	59762-1005	0d2a8657-0319-491c-b79b-78ca87658539	1	2015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CABERGOLINE	ACTIVE INGREDIENT	LL60K9J05T	CABERGOLINE TABLET [GREENSTONE LLC]	3
CABERGOLINE	ACTIVE MOIETY	LL60K9J05T	CABERGOLINE TABLET [GREENSTONE LLC]	3
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	CABERGOLINE TABLET [GREENSTONE LLC]	3
LEUCINE	INACTIVE INGREDIENT	GMW67QNF9C	CABERGOLINE TABLET [GREENSTONE LLC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59762-1005	CABERGOLINE TABLET [MYLAN PHARMACEUTICALS INC.]	9	Current NDC, Legacy NDC, 1 package rows	20250528_e497366b-a124-4d7f-bd45-a883c392d4bb.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cabergoline	CABERGOLINE	Mylan Pharmaceuticals Inc.	e497366b-a124-4d7f-bd45-a883c392d4bb	2026-06-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020664 application number: NDA020664 ndc (product): 59762-1005

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
LL60K9J05T	CABERGOLINE	81409-90-7	CABERGOLINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
199703	cabergoline 0.5 MG Oral Tablet	PSN	e497366b-a124-4d7f-bd45-a883c392d4bb	11
199703	cabergoline 0.5 MG Oral Tablet	SCD	e497366b-a124-4d7f-bd45-a883c392d4bb	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59762-1005-1	59762100501	8 TABLET in 1 BOTTLE (59762-1005-1)	8 tablet	2014-09-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cabergoline	Mylan Pharmaceuticals Inc. \| Pfizer Inc \| Pfizer Italia S.r.l.	2026-06-30	HUMAN PRESCRIPTION DRUG LABEL	12