Pramipexole Dihydrochloride

Product NDC: 69680-146
11-digit product format: 696800146
Labeler code: 69680
Product ID: 69680-146_232ae12c-b9bc-4ca7-982e-d6f43b6c8eec
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pramipexole Dihydrochloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Vitruvias Therapeutics, Inc.
Application: ANDA212797
Marketing category: ANDA
Marketing start: 2021-08-27
Substance: PRAMIPEXOLE DIHYDROCHLORIDE
Active strength: .75 mg/1
Pharmacologic classes: Dopamine Agonists [MoA], Nonergot Dopamine Agonist [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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A212797-001	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG	TABLET, EXTENDED RELEASE / ORAL	AB		2021-06-11
A212797-002	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET, EXTENDED RELEASE / ORAL	AB		2021-06-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212797-001	AB
A212797-002	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 2 · 66 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212797-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212797-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212797-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212797-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212797-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212797-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212797-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212797-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212797-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212797-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212797-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212797-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212797-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212797-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212797-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212797-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212797-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212797-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212797-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212797-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212797-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212797-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212797-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212797-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212797-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212797-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212797-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212797-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212797-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212797-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212797-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212797-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212797-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212797-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-11	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212797-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212797-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212797-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A212797-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-11	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212797-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-11	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212797-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-11	`6a51e52b5d6a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 66 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	A212797-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212797-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212797-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212797-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212797-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212797-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212797-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212797-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212797-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212797-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212797-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212797-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212797-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212797-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212797-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212797-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212797-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212797-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212797-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212797-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212797-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212797-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212797-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212797-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212797-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212797-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212797-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212797-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212797-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212797-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212797-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212797-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212797-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212797-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212797-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212797-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212797-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A212797-002	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212797-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212797-002	AB	1	`6a51e52b5d6a…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PRAMIPEXOLE DIHYDROCHLORIDE	.75 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3D867NP06J	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
901541	Internal RxNorm lookup
901546	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
d07aad1b-e078-4fca-8386-ca2e8e899688	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a67b8488-0225-64b1-be81-5cbe60d285a5	Product name	9	20221116
3863aae0-7028-3427-389e-3f6c8692e587	Product name	3	20190117

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69680-146-30	Pramipexole Dihydrochloride	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69680-146-30	EA - Each	69680-146	f8bd0273-59ce-455e-ab51-2b064f59d238	1	2021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69680-146	PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE (PRAMIPEXOLE DIHYDROCHLORIDE) TABLET, EXTENDED RELEASE PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE [VITRUVIAS THERAPEUTICS, INC.]	4	Current NDC, Legacy NDC, 1 package rows	20240725_d07aad1b-e078-4fca-8386-ca2e8e899688.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pramipexole Dihydrochloride Extended-Release	PRAMIPEXOLE DIHYDROCHLORIDE	Vitruvias Therapeutics, Inc.	d07aad1b-e078-4fca-8386-ca2e8e899688	2024-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212797 application number: ANDA212797 ndc (product): 69680-146
Pramipexole Dihydrochloride Extended-Release	PRAMIPEXOLE DIHYDROCHLORIDE	Xiamen LP Pharmaceutical Co., Ltd.	1cbd8ddf-4fc1-4cd0-906d-a55a4b8b1c3c	2021-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212797 application number: ANDA212797

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3D867NP06J	PRAMIPEXOLE DIHYDROCHLORIDE	191217-81-9	PRAMIPEXOLE DIHYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
901541	pramipexole dihydrochloride 0.375 MG 24HR Extended Release Oral Tablet	PSN	d07aad1b-e078-4fca-8386-ca2e8e899688	4
901546	pramipexole dihydrochloride 0.75 MG 24HR Extended Release Oral Tablet	PSN	d07aad1b-e078-4fca-8386-ca2e8e899688	4
901541	24 HR pramipexole dihydrochloride 0.375 MG Extended Release Oral Tablet	SCD	d07aad1b-e078-4fca-8386-ca2e8e899688	4
901546	24 HR pramipexole dihydrochloride 0.75 MG Extended Release Oral Tablet	SCD	d07aad1b-e078-4fca-8386-ca2e8e899688	4
901541	pramipexole dihydrochloride 0.375 MG 24 HR Extended Release Oral Tablet	SY	d07aad1b-e078-4fca-8386-ca2e8e899688	4
901546	pramipexole dihydrochloride 0.75 MG 24 HR Extended Release Oral Tablet	SY	d07aad1b-e078-4fca-8386-ca2e8e899688	4
901546	pramipexole dihydrochloride 750 MCG 24 HR Extended Release Oral Tablet	SY	d07aad1b-e078-4fca-8386-ca2e8e899688	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
69680-146-30	69680014630	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (69680-146-30)	2021-08-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pramipexole Dihydrochloride Extended-Release	Vitruvias Therapeutics, Inc.	2024-07-23	HUMAN PRESCRIPTION DRUG LABEL	4