Pramipexole Dihydrochloride

Product NDC: 13668-092
11-digit product format: 136680092
Labeler code: 13668
Product ID: 13668-092_f3214c59-f86f-47d6-9ddb-0af985d11a6c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pramipexole Dihydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Torrent Pharmaceuticals Limited
Application: ANDA090865
Marketing category: ANDA
Marketing start: 2010-10-08
Substance: PRAMIPEXOLE DIHYDROCHLORIDE
Active strength: .25 mg/1
Pharmacologic classes: Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PRAMIPEXOLE DIHYDROCHLORIDE	.25 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	3D867NP06J
Rxcui	858625, 859033, 859040, 859044, 859048, 859052

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	SPL version
13668-092-05	Pramipexole Dihydrochloride	500 in 1 BOTTLE	TABLET	500	22
13668-092-30	Pramipexole Dihydrochloride	30 in 1 BOTTLE	TABLET	30	22
13668-092-41	Pramipexole Dihydrochloride	5500 in 1 BOTTLE	TABLET	5500	22
13668-092-90	Pramipexole Dihydrochloride	90 in 1 BOTTLE	TABLET	90	22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
13668-092-05	EA - Each	13668-092	de149ecb-8e97-4e94-b68f-fb31c3d29e26	1	2012-07-24
13668-092-90	EA - Each	13668-092	49e5a018-9681-4c84-99d7-b86da6e19605	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PRAMIPEXOLE DIHYDROCHLORIDE	ACTIVE INGREDIENT	3D867NP06J	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]	1000
PRAMIPEXOLE	ACTIVE MOIETY	83619PEU5T	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]	1000
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]	1000
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]	1000
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]	1000
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]	1000
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]	1000
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]	1000
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]	1000
PRAMIPEXOLE DIHYDROCHLORIDE	ACTIVE INGREDIENT	3D867NP06J	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [TORRENT PHARMACEUTICALS LIMITED]	7
PRAMIPEXOLE	ACTIVE MOIETY	83619PEU5T	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [TORRENT PHARMACEUTICALS LIMITED]	7
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [TORRENT PHARMACEUTICALS LIMITED]	7
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [TORRENT PHARMACEUTICALS LIMITED]	7
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [TORRENT PHARMACEUTICALS LIMITED]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [TORRENT PHARMACEUTICALS LIMITED]	7
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [TORRENT PHARMACEUTICALS LIMITED]	7
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [TORRENT PHARMACEUTICALS LIMITED]	7
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [TORRENT PHARMACEUTICALS LIMITED]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13668-092	PRAMIPEXOLE DIHYDROCHLORIDE TABLET [TORRENT PHARMACEUTICALS LIMITED]	20	Current NDC, Legacy NDC, 4 package rows	20240816_60167d7c-469f-455a-a113-561841af5e59.zip

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
859040	pramipexole dihydrochloride 0.25 MG Oral Tablet	PSN	dd4b4e2a-97b5-417d-bb90-bec692dc359b	1012
859040	pramipexole dihydrochloride 0.25 MG Oral Tablet	SCD	dd4b4e2a-97b5-417d-bb90-bec692dc359b	1012
859040	pramipexole dihydrochloride 0.25 MG (pramipexole 0.18 MG) Oral Tablet	SY	dd4b4e2a-97b5-417d-bb90-bec692dc359b	1012
859033	pramipexole dihydrochloride 0.125 MG Oral Tablet	PSN	60167d7c-469f-455a-a113-561841af5e59	22
859040	pramipexole dihydrochloride 0.25 MG Oral Tablet	PSN	60167d7c-469f-455a-a113-561841af5e59	22
859044	pramipexole dihydrochloride 0.5 MG Oral Tablet	PSN	60167d7c-469f-455a-a113-561841af5e59	22
858625	pramipexole dihydrochloride 0.75 MG Oral Tablet	PSN	60167d7c-469f-455a-a113-561841af5e59	22
859052	pramipexole dihydrochloride 1 MG Oral Tablet	PSN	60167d7c-469f-455a-a113-561841af5e59	22
859048	pramipexole dihydrochloride 1.5 MG Oral Tablet	PSN	60167d7c-469f-455a-a113-561841af5e59	22
859033	pramipexole dihydrochloride 0.125 MG Oral Tablet	SCD	60167d7c-469f-455a-a113-561841af5e59	22
859040	pramipexole dihydrochloride 0.25 MG Oral Tablet	SCD	60167d7c-469f-455a-a113-561841af5e59	22
859044	pramipexole dihydrochloride 0.5 MG Oral Tablet	SCD	60167d7c-469f-455a-a113-561841af5e59	22
858625	pramipexole dihydrochloride 0.75 MG Oral Tablet	SCD	60167d7c-469f-455a-a113-561841af5e59	22
859052	pramipexole dihydrochloride 1 MG Oral Tablet	SCD	60167d7c-469f-455a-a113-561841af5e59	22
859048	pramipexole dihydrochloride 1.5 MG Oral Tablet	SCD	60167d7c-469f-455a-a113-561841af5e59	22
859033	pramipexole dihydrochloride 0.125 MG (pramipexole 0.088 MG) Oral Tablet	SY	60167d7c-469f-455a-a113-561841af5e59	22
859040	pramipexole dihydrochloride 0.25 MG (pramipexole 0.18 MG) Oral Tablet	SY	60167d7c-469f-455a-a113-561841af5e59	22
859044	pramipexole dihydrochloride 0.5 MG (pramipexole 0.35 MG) Oral Tablet	SY	60167d7c-469f-455a-a113-561841af5e59	22
858625	pramipexole dihydrochloride 0.75 MG (pramipexole 0.525 MG) Oral Tablet	SY	60167d7c-469f-455a-a113-561841af5e59	22
859052	pramipexole dihydrochloride 1 MG (pramipexole 0.7 MG) Oral Tablet	SY	60167d7c-469f-455a-a113-561841af5e59	22
859048	pramipexole dihydrochloride 1.5 MG (equivalent to pramipexole 1 MG) Oral Tablet	SY	60167d7c-469f-455a-a113-561841af5e59	22
859040	pramipexole dihydrochloride 0.25 MG Oral Tablet	PSN	978c0e89-35f0-44a2-9302-8bed7e5d60e0	10
859040	pramipexole dihydrochloride 0.25 MG Oral Tablet	SCD	978c0e89-35f0-44a2-9302-8bed7e5d60e0	10
859040	pramipexole dihydrochloride 0.25 MG (pramipexole 0.18 MG) Oral Tablet	SY	978c0e89-35f0-44a2-9302-8bed7e5d60e0	10
859040	pramipexole dihydrochloride 0.25 MG Oral Tablet	PSN	f4d97c2e-f447-4cfe-b9d4-852323f0cfb5	5
859044	pramipexole dihydrochloride 0.5 MG Oral Tablet	PSN	f4d97c2e-f447-4cfe-b9d4-852323f0cfb5	5
859052	pramipexole dihydrochloride 1 MG Oral Tablet	PSN	f4d97c2e-f447-4cfe-b9d4-852323f0cfb5	5
859040	pramipexole dihydrochloride 0.25 MG Oral Tablet	SCD	f4d97c2e-f447-4cfe-b9d4-852323f0cfb5	5
859044	pramipexole dihydrochloride 0.5 MG Oral Tablet	SCD	f4d97c2e-f447-4cfe-b9d4-852323f0cfb5	5
859052	pramipexole dihydrochloride 1 MG Oral Tablet	SCD	f4d97c2e-f447-4cfe-b9d4-852323f0cfb5	5
859040	pramipexole dihydrochloride 0.25 MG (pramipexole 0.18 MG) Oral Tablet	SY	f4d97c2e-f447-4cfe-b9d4-852323f0cfb5	5
859044	pramipexole dihydrochloride 0.5 MG (pramipexole 0.35 MG) Oral Tablet	SY	f4d97c2e-f447-4cfe-b9d4-852323f0cfb5	5
859052	pramipexole dihydrochloride 1 MG (pramipexole 0.7 MG) Oral Tablet	SY	f4d97c2e-f447-4cfe-b9d4-852323f0cfb5	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
13668-092-05	13668009205	500 TABLET in 1 BOTTLE (13668-092-05)	500 tablet	2010-10-08	0000-00-00	No	No	Current
13668-092-30	13668009230	30 TABLET in 1 BOTTLE (13668-092-30)	30 tablet	2010-10-08	0000-00-00	No	No	Current
13668-092-41	13668009241	5500 TABLET in 1 BOTTLE (13668-092-41)	5500 tablet	2010-10-08	0000-00-00	No	No	Current
13668-092-74	13668009274	100 TABLET in 1 CARTON (13668-092-74)	100 tablet	2010-10-08	0000-00-00	No	No	Current
13668-092-90	13668009290	90 TABLET in 1 BOTTLE (13668-092-90)	90 tablet	2010-10-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pramipexole Dihydrochloride	Bryant Ranch Prepack	2026-04-02	HUMAN PRESCRIPTION DRUG LABEL	1012
Pramipexole Dihydrochloride	Torrent Pharmaceuticals Limited \| Torrent Pharma, Inc.	2026-03-31	HUMAN PRESCRIPTION DRUG LABEL	22
Pramipexole Dihydrochloride	American Health Packaging	2026-03-03	HUMAN PRESCRIPTION DRUG LABEL	5
Pramipexole Dihydrochloride	Major Pharmaceuticals	2026-01-21	HUMAN PRESCRIPTION DRUG LABEL	10

Pramipexole Dihydrochloride

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#