Bromocriptine Mesylate

Product NDC: 70954-951
11-digit product format: 709540951
Labeler code: 70954
Product ID: 70954-951_45243870-6592-4cdf-a2a1-2e8ea48a47d8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Bromocriptine Mesylate
Dosage form: CAPSULE
Route: ORAL
Labeler: ANI Pharmaceuticals, Inc.
Application: NDA017962
Marketing category: NDA
Marketing start: 2026-04-06
Substance: BROMOCRIPTINE MESYLATE
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

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N017962-001	PARLODEL	BROMOCRIPTINE MESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982
N017962-002	PARLODEL	BROMOCRIPTINE MESYLATE	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD	1982-03-01

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N017962-001	AB
N017962-002	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 3 · 82 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	N017962-001	PARLODEL	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017962-002	PARLODEL	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD	1982-03-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017962-001	PARLODEL	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017962-002	PARLODEL	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD	1982-03-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017962-001	PARLODEL	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017962-002	PARLODEL	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD	1982-03-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017962-001	PARLODEL	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017962-002	PARLODEL	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD	1982-03-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017962-001	PARLODEL	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017962-002	PARLODEL	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD	1982-03-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017962-001	PARLODEL	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017962-002	PARLODEL	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD	1982-03-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017962-001	PARLODEL	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017962-002	PARLODEL	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD	1982-03-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017962-001	PARLODEL	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017962-002	PARLODEL	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD	1982-03-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017962-001	PARLODEL	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017962-002	PARLODEL	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD	1982-03-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017962-001	PARLODEL	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017962-002	PARLODEL	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD	1982-03-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017962-001	PARLODEL	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017962-002	PARLODEL	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD	1982-03-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017962-001	PARLODEL	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017962-002	PARLODEL	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD	1982-03-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017962-001	PARLODEL	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017962-002	PARLODEL	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD	1982-03-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017962-001	PARLODEL	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982		`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N017962-002	PARLODEL	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD	1982-03-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017962-001	PARLODEL	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017962-002	PARLODEL	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD	1982-03-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017962-001	PARLODEL	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N017962-002	PARLODEL	EQ 5MG BASE	CAPSULE / ORAL	AB	RLD	1982-03-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017962-001	PARLODEL	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N017962-002	PARLODEL	EQ 5MG BASE	CAPSULE / ORAL	AB	RLD	1982-03-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017962-001	PARLODEL	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N017962-002	PARLODEL	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	AB	RLD	1982-03-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017962-001	PARLODEL	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N017962-002	PARLODEL	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	AB	RLD	1982-03-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017962-001	PARLODEL	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD, Approved before 1982		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N017962-002	PARLODEL	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	AB	RLD	1982-03-01	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N017962-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017962-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017962-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017962-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017962-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017962-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017962-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017962-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017962-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017962-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017962-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017962-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017962-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017962-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017962-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017962-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017962-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017962-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017962-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017962-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017962-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017962-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017962-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017962-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017962-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017962-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017962-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N017962-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017962-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017962-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017962-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N017962-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017962-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N017962-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017962-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N017962-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017962-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N017962-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017962-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N017962-002	AB	1	`782e0a99824c…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BROMOCRIPTINE MESYLATE	5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
FFP983J3OD	Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
17f3a343-1782-4799-95ba-31dfe93be2cf	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
90f4f2b3-d032-9eaf-93c5-f165b5a4c90e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70954-951-10	Bromocriptine Mesylate	30 in 1 BOTTLE	CAPSULE	30		2
70954-951-20	Bromocriptine Mesylate	100 in 1 BOTTLE	CAPSULE	100		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70954-951-10	EA - Each	70954-951	b020e95d-567a-4b6f-bc0d-de9cdf1125c5	1	2026-05-22

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bromocriptine Mesylate	BROMOCRIPTINE MESYLATE	ANI Pharmaceuticals, Inc.	17f3a343-1782-4799-95ba-31dfe93be2cf	2026-07-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017962 application number: NDA017962 ndc (product): 70954-951
Bromocriptine Mesylate	BROMOCRIPTINE MESYLATE	American Health Packaging	ddd292a5-72af-448f-8b88-cc4fd99ec783	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017962 application number: NDA017962

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
FFP983J3OD	BROMOCRIPTINE MESYLATE	22260-51-1	BROMOCRIPTINE MESYLATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197411	bromocriptine mesylate 2.5 MG Oral Tablet	PSN	17f3a343-1782-4799-95ba-31dfe93be2cf	2
197412	bromocriptine mesylate 5 MG Oral Capsule	PSN	17f3a343-1782-4799-95ba-31dfe93be2cf	2
197411	bromocriptine 2.5 MG Oral Tablet	SCD	17f3a343-1782-4799-95ba-31dfe93be2cf	2
197412	bromocriptine 5 MG Oral Capsule	SCD	17f3a343-1782-4799-95ba-31dfe93be2cf	2
197411	bromocriptine (as bromocriptine mesylate) 2.5 MG Oral Tablet	SY	17f3a343-1782-4799-95ba-31dfe93be2cf	2
197412	bromocriptine 5 MG (as bromocriptine mesylate 5.74 MG) Oral Capsule	SY	17f3a343-1782-4799-95ba-31dfe93be2cf	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70954-951-10	70954095110	30 CAPSULE in 1 BOTTLE (70954-951-10)	30 capsule	2026-04-06	No	No	Current
70954-951-20	70954095120	100 CAPSULE in 1 BOTTLE (70954-951-20)	100 capsule	2026-04-06	No	No	Current