PRAMIPEXOLE DIHYDROCHLORIDE

Product NDC: 65841-736
11-digit product format: 658410736
Labeler code: 65841
Product ID: 65841-736_45a8b1f5-90da-46df-9f01-2f174331f3e8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PRAMIPEXOLE DIHYDROCHLORIDE
Dosage form: TABLET
Route: ORAL
Labeler: Zydus Lifesciences Limited
Application: ANDA078920
Marketing category: ANDA
Marketing start: 2010-07-10
Marketing end: 0000-00-00
Substance: PRAMIPEXOLE DIHYDROCHLORIDE
Active strength: 1 mg/1
Pharmacologic classes: Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	65841-736		D	Discontinued by firm	2026-10-15
excluded package	package	65841-736	65841-736-05	D	Discontinued by firm	2026-10-15
excluded package	package	65841-736	65841-736-10	D	Discontinued by firm	2026-10-15
excluded package	package	65841-736	65841-736-16	D	Discontinued by firm	2026-10-15

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 · 8 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65841-736-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65841-736-16	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65841-736-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65841-736-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65841-736-16	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65841-736-05	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A078920-001	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	AB	2010-07-06
A078920-002	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	AB	2010-07-06
A078920-003	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	AB	2010-07-06
A078920-004	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	AB	2010-07-06
A078920-005	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	AB	2010-07-06
A078920-006	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	AB	2022-11-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
A078920-001	AB
A078920-002	AB
A078920-003	AB
A078920-004	AB
A078920-005	AB
A078920-006	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 7 · 247 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
2026-10-15 13:18:30	2026-09	A078920-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	AB	2010-07-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078920-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	AB	2010-07-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078920-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	AB	2010-07-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078920-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	AB	2010-07-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078920-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	AB	2010-07-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078920-006	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	AB	2022-11-23	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A078920-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	AB	2010-07-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078920-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	AB	2010-07-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078920-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	AB	2010-07-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078920-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	AB	2010-07-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078920-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	AB	2010-07-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078920-006	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	AB	2022-11-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078920-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	AB	2010-07-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078920-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	AB	2010-07-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078920-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	AB	2010-07-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078920-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	AB	2010-07-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078920-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	AB	2010-07-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078920-006	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	AB	2022-11-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078920-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	AB	2010-07-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078920-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	AB	2010-07-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078920-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	AB	2010-07-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078920-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	AB	2010-07-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078920-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	AB	2010-07-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078920-006	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	AB	2022-11-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078920-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	AB	2010-07-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078920-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	AB	2010-07-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078920-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	AB	2010-07-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078920-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	AB	2010-07-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078920-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	AB	2010-07-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078920-006	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	AB	2022-11-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078920-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	AB	2010-07-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078920-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	AB	2010-07-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078920-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	AB	2010-07-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078920-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	AB	2010-07-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078920-005	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET / ORAL	AB	2010-07-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078920-006	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET / ORAL	AB	2022-11-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078920-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG	TABLET / ORAL	AB	2010-07-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078920-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG	TABLET / ORAL	AB	2010-07-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078920-003	PRAMIPEXOLE DIHYDROCHLORIDE	0.5MG	TABLET / ORAL	AB	2010-07-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078920-004	PRAMIPEXOLE DIHYDROCHLORIDE	1MG	TABLET / ORAL	AB	2010-07-06	`fd3edfee7708…`

Observed Orange Book normalized TE history#

Normalized TE history page 4 of 7 · 247 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A078920-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078920-005	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078920-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078920-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078920-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078920-004	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078920-005	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078920-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078920-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078920-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078920-004	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078920-005	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078920-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078920-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078920-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078920-004	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078920-005	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078920-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078920-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078920-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078920-004	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078920-005	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078920-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078920-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078920-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078920-004	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078920-005	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078920-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078920-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078920-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078920-004	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078920-005	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078920-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078920-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078920-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078920-004	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078920-005	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078920-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078920-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078920-003	AB	1	`b00525d2431f…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PRAMIPEXOLE DIHYDROCHLORIDE	ACTIVE INGREDIENT	3D867NP06J	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [CADILA HEALTHCARE LIMITED]	2
PRAMIPEXOLE	ACTIVE MOIETY	83619PEU5T	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [CADILA HEALTHCARE LIMITED]	2
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [CADILA HEALTHCARE LIMITED]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [CADILA HEALTHCARE LIMITED]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [CADILA HEALTHCARE LIMITED]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [CADILA HEALTHCARE LIMITED]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [CADILA HEALTHCARE LIMITED]	2
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [CADILA HEALTHCARE LIMITED]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [CADILA HEALTHCARE LIMITED]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [CADILA HEALTHCARE LIMITED]	2
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [CADILA HEALTHCARE LIMITED]	2

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65841-736-05	65841073605	500 TABLET in 1 BOTTLE (65841-736-05)	500 tablet	2010-07-10	0000-00-00	No	No	Current
65841-736-10	65841073610	1000 TABLET in 1 BOTTLE (65841-736-10)	1000 tablet	2010-07-10	0000-00-00	No	No	Current
65841-736-16	65841073616	90 TABLET in 1 BOTTLE (65841-736-16)	90 tablet	2010-07-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PRAMIPEXOLE DIHYDROCHLORIDE TABLETS	Zydus Lifesciences Limited	2024-12-03	HUMAN PRESCRIPTION DRUG LABEL	10