Cabergoline

Product NDC: 64380-202
Requested package NDC: 64380-202-01
11-digit product format: 643800202
Labeler code: 64380
Product ID: 64380-202_6d882cc3-a1a6-48dd-8200-af57b67d5cea
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cabergoline
Dosage form: TABLET
Route: ORAL
Labeler: Strides Pharma Science Limited
Application: ANDA076310
Marketing category: ANDA
Marketing start: 2024-02-27
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

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	64380-202	64380-202-01	U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`1332a3947898…`	`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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076310-001	CABERGOLINE	CABERGOLINE	0.5MG	TABLET / ORAL	AB		2005-12-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076310-001	AB

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076310-001	CABERGOLINE	0.5MG	TABLET / ORAL	AB		2005-12-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076310-001	CABERGOLINE	0.5MG	TABLET / ORAL	AB		2005-12-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076310-001	CABERGOLINE	0.5MG	TABLET / ORAL	AB		2005-12-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076310-001	CABERGOLINE	0.5MG	TABLET / ORAL	AB		2005-12-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076310-001	CABERGOLINE	0.5MG	TABLET / ORAL	AB		2005-12-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076310-001	CABERGOLINE	0.5MG	TABLET / ORAL	AB		2005-12-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076310-001	CABERGOLINE	0.5MG	TABLET / ORAL	AB		2005-12-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076310-001	CABERGOLINE	0.5MG	TABLET / ORAL	AB		2005-12-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076310-001	CABERGOLINE	0.5MG	TABLET / ORAL	AB		2005-12-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076310-001	CABERGOLINE	0.5MG	TABLET / ORAL	AB		2005-12-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076310-001	CABERGOLINE	0.5MG	TABLET / ORAL	AB		2005-12-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076310-001	CABERGOLINE	0.5MG	TABLET / ORAL	AB		2005-12-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076310-001	CABERGOLINE	0.5MG	TABLET / ORAL	AB		2005-12-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076310-001	CABERGOLINE	0.5MG	TABLET / ORAL	AB		2005-12-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076310-001	CABERGOLINE	0.5MG	TABLET / ORAL	AB		2005-12-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076310-001	CABERGOLINE	0.5MG	TABLET / ORAL	AB		2005-12-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076310-001	CABERGOLINE	0.5MG	TABLET / ORAL			2005-12-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076310-001	CABERGOLINE	0.5MG	TABLET / ORAL	AB	RS	2005-12-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076310-001	CABERGOLINE	0.5MG	TABLET / ORAL			2005-12-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076310-001	CABERGOLINE	0.5MG	TABLET / ORAL			2005-12-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076310-001	CABERGOLINE	0.5MG	TABLET / ORAL			2005-12-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076310-001	CABERGOLINE	0.5MG	TABLET / ORAL			2005-12-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076310-001	CABERGOLINE	0.5MG	TABLET / ORAL			2005-12-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076310-001	CABERGOLINE	0.5MG	TABLET / ORAL	AB	RS	2005-12-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076310-001	CABERGOLINE	0.5MG	TABLET / ORAL	AB	RS	2005-12-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076310-001	CABERGOLINE	0.5MG	TABLET / ORAL	AB	RS	2005-12-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076310-001	CABERGOLINE	0.5MG	TABLET / ORAL	AB	RS	2005-12-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076310-001	CABERGOLINE	0.5MG	TABLET / ORAL	AB		2005-12-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076310-001	CABERGOLINE	0.5MG	TABLET / ORAL	AB		2005-12-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076310-001	CABERGOLINE	0.5MG	TABLET / ORAL	AB		2005-12-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076310-001	CABERGOLINE	0.5MG	TABLET / ORAL	AB		2005-12-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076310-001	CABERGOLINE	0.5MG	TABLET / ORAL	AB		2005-12-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076310-001	CABERGOLINE	0.5MG	TABLET / ORAL	AB		2005-12-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076310-001	CABERGOLINE	0.5MG	TABLET / ORAL	AB		2005-12-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076310-001	CABERGOLINE	0.5MG	TABLET / ORAL	AB		2005-12-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076310-001	CABERGOLINE	0.5MG	TABLET / ORAL	AB		2005-12-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076310-001	CABERGOLINE	0.5MG	TABLET / ORAL	AB		2005-12-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076310-001	CABERGOLINE	0.5MG	TABLET / ORAL	AB		2005-12-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076310-001	CABERGOLINE	0.5MG	TABLET / ORAL	AB		2005-12-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076310-001	CABERGOLINE	0.5MG	TABLET / ORAL	AB		2005-12-29	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076310-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076310-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076310-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076310-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076310-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076310-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076310-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076310-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076310-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076310-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076310-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076310-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076310-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076310-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076310-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076310-001	AB	1	`5d02ea3f76ae…`
2019-12-13 00:20 UTC	2019-12	A076310-001	AB	1	`74a2ff9319b5…`
2020-11-12 02:37 UTC	2020-11	A076310-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076310-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076310-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076310-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076310-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076310-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076310-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076310-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076310-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076310-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076310-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076310-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076310-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076310-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076310-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076310-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076310-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A076310-001	AB	1	`a50c72e98297…`

Additional Listing Data#

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

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
518d43ee-8d33-4abd-96a5-1b6890e59b08	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
64380-202-01	Cabergoline	8 in 1 BOTTLE	TABLET	8		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64380-202	CABERGOLINE TABLET [STRIDES PHARMA SCIENCE LIMITED]	5	Current NDC, 1 package rows	20250403_518d43ee-8d33-4abd-96a5-1b6890e59b08.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cabergoline	CABERGOLINE	SOLA Pharmaceuticals, LLC	275a6a25-c3c9-4258-a610-0b00752517f7	2025-12-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076310 application number: ANDA076310
Cabergoline	CABERGOLINE	Strides Pharma Science Limited	518d43ee-8d33-4abd-96a5-1b6890e59b08	2025-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076310 application number: ANDA076310 ndc (package): 64380-202-01 ndc (product): 64380-202 ndc11 (package): 64380020201
Cabergoline	CABERGOLINE	A-S Medication Solutions	7699d938-3f62-4e13-9b33-3e581310b9f3	2023-08-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076310 application number: ANDA076310
Cabergoline	CABERGOLINE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	bc44d11b-b3f0-4e3d-9da3-4f8852d11734	2023-07-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076310 application number: ANDA076310

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	518d43ee-8d33-4abd-96a5-1b6890e59b08	5
199703	cabergoline 0.5 MG Oral Tablet	SCD	518d43ee-8d33-4abd-96a5-1b6890e59b08	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
64380-202-01	64380020201	8 TABLET in 1 BOTTLE (64380-202-01)	8 tablet	2024-02-27	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CABERGOLINE TABLETS, USP Rx only	Strides Pharma Science Limited \| Strides Pharma Global Pte. Ltd. \| Strides Pharma, Inc	2025-04-01	HUMAN PRESCRIPTION DRUG LABEL	5