Pramipexole dihydrochloride

Product NDC: 55111-613
11-digit product format: 551110613
Labeler code: 55111
Product ID: 55111-613_4dfe5cc9-1281-c6dc-a6dc-6113fd0aed67
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pramipexole dihydrochloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Dr. Reddy's Laboratories Limited
Application: ANDA203354
Marketing category: ANDA
Marketing start: 2015-08-14
Substance: PRAMIPEXOLE DIHYDROCHLORIDE
Active strength: 1.5 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 42.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A203354-001	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2015-08-07
A203354-002	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07
A203354-003	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07
A203354-004	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07
A203354-005	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	4.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A203354-001	AB
A203354-002	AB
A203354-003	AB
A203354-004	AB
A203354-005	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 6 · 210 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
2026-08-18 06:07:40	2026-07	A203354-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2015-08-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203354-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203354-003	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203354-004	PRAMIPEXOLE DIHYDROCHLORIDE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203354-005	PRAMIPEXOLE DIHYDROCHLORIDE	4.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203354-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2015-08-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203354-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203354-003	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203354-004	PRAMIPEXOLE DIHYDROCHLORIDE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203354-005	PRAMIPEXOLE DIHYDROCHLORIDE	4.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203354-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2015-08-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203354-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203354-003	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203354-004	PRAMIPEXOLE DIHYDROCHLORIDE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203354-005	PRAMIPEXOLE DIHYDROCHLORIDE	4.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203354-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2015-08-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203354-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203354-003	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203354-004	PRAMIPEXOLE DIHYDROCHLORIDE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203354-005	PRAMIPEXOLE DIHYDROCHLORIDE	4.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203354-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2015-08-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203354-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203354-003	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203354-004	PRAMIPEXOLE DIHYDROCHLORIDE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203354-005	PRAMIPEXOLE DIHYDROCHLORIDE	4.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203354-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2015-08-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203354-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203354-003	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203354-004	PRAMIPEXOLE DIHYDROCHLORIDE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203354-005	PRAMIPEXOLE DIHYDROCHLORIDE	4.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203354-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2015-08-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203354-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203354-003	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203354-004	PRAMIPEXOLE DIHYDROCHLORIDE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203354-005	PRAMIPEXOLE DIHYDROCHLORIDE	4.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203354-001	PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2015-08-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203354-002	PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203354-003	PRAMIPEXOLE DIHYDROCHLORIDE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203354-004	PRAMIPEXOLE DIHYDROCHLORIDE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203354-005	PRAMIPEXOLE DIHYDROCHLORIDE	4.5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2015-08-07	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 210 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A203354-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203354-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203354-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203354-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203354-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203354-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203354-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203354-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203354-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203354-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203354-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203354-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203354-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203354-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203354-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203354-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203354-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203354-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203354-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203354-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203354-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203354-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203354-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203354-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203354-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203354-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203354-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203354-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203354-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203354-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203354-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203354-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203354-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203354-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203354-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203354-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203354-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203354-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203354-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203354-005	AB	1	`2680178bc6a6…`

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	1.5 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 · 5 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
901534	Internal RxNorm lookup
901541	Internal RxNorm lookup
901546	Internal RxNorm lookup
901550	Internal RxNorm lookup
901555	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
00699692-532a-68fd-8a51-3770a81b2208	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
55111-613-30	Pramipexole dihydrochloride	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30		16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55111-613-30	EA - Each	55111-613	f2eab5bc-1b16-4b08-97b3-fb011e7e303a	1	2015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PRAMIPEXOLE DIHYDROCHLORIDE	ACTIVE INGREDIENT	3D867NP06J	PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE PRAMIPEXOLE DIHYDROCHLORIDE (PRAMIPEXOLE DIHYDROCHLORIDE) TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	7
PRAMIPEXOLE	ACTIVE MOIETY	83619PEU5T	PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE PRAMIPEXOLE DIHYDROCHLORIDE (PRAMIPEXOLE DIHYDROCHLORIDE) TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	7
CARBOMER HOMOPOLYMER TYPE A	INACTIVE INGREDIENT	F68VH75CJC	PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE PRAMIPEXOLE DIHYDROCHLORIDE (PRAMIPEXOLE DIHYDROCHLORIDE) TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	7
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE PRAMIPEXOLE DIHYDROCHLORIDE (PRAMIPEXOLE DIHYDROCHLORIDE) TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	7
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE PRAMIPEXOLE DIHYDROCHLORIDE (PRAMIPEXOLE DIHYDROCHLORIDE) TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE PRAMIPEXOLE DIHYDROCHLORIDE (PRAMIPEXOLE DIHYDROCHLORIDE) TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	7
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE PRAMIPEXOLE DIHYDROCHLORIDE (PRAMIPEXOLE DIHYDROCHLORIDE) TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	7
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE PRAMIPEXOLE DIHYDROCHLORIDE (PRAMIPEXOLE DIHYDROCHLORIDE) TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55111-613	PRAMIPEXOLE DIHYDROCHLORIDE TABLET, EXTENDED RELEASE PRAMIPEXOLE DIHYDROCHLORIDE (PRAMIPEXOLE DIHYDROCHLORIDE) TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	16	Current NDC, Legacy NDC, 1 package rows	20240829_00699692-532a-68fd-8a51-3770a81b2208.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pramipexole dihydrochloride	PRAMIPEXOLE DIHYDROCHLORIDE	Dr. Reddy's Laboratories Limited	00699692-532a-68fd-8a51-3770a81b2208	2021-08-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203354 application number: ANDA203354 ndc (product): 55111-613

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	00699692-532a-68fd-8a51-3770a81b2208	16
901546	pramipexole dihydrochloride 0.75 MG 24HR Extended Release Oral Tablet	PSN	00699692-532a-68fd-8a51-3770a81b2208	16
901550	pramipexole dihydrochloride 1.5 MG 24HR Extended Release Oral Tablet	PSN	00699692-532a-68fd-8a51-3770a81b2208	16
901555	pramipexole dihydrochloride 3 MG 24HR Extended Release Oral Tablet	PSN	00699692-532a-68fd-8a51-3770a81b2208	16
901534	pramipexole dihydrochloride 4.5 MG 24HR Extended Release Oral Tablet	PSN	00699692-532a-68fd-8a51-3770a81b2208	16
901541	24 HR pramipexole dihydrochloride 0.375 MG Extended Release Oral Tablet	SCD	00699692-532a-68fd-8a51-3770a81b2208	16
901546	24 HR pramipexole dihydrochloride 0.75 MG Extended Release Oral Tablet	SCD	00699692-532a-68fd-8a51-3770a81b2208	16
901550	24 HR pramipexole dihydrochloride 1.5 MG Extended Release Oral Tablet	SCD	00699692-532a-68fd-8a51-3770a81b2208	16
901555	24 HR pramipexole dihydrochloride 3 MG Extended Release Oral Tablet	SCD	00699692-532a-68fd-8a51-3770a81b2208	16
901534	24 HR pramipexole dihydrochloride 4.5 MG Extended Release Oral Tablet	SCD	00699692-532a-68fd-8a51-3770a81b2208	16
901541	pramipexole dihydrochloride 0.375 MG 24 HR Extended Release Oral Tablet	SY	00699692-532a-68fd-8a51-3770a81b2208	16
901546	pramipexole dihydrochloride 0.75 MG 24 HR Extended Release Oral Tablet	SY	00699692-532a-68fd-8a51-3770a81b2208	16
901550	pramipexole dihydrochloride 1.5 MG 24 HR Extended Release Oral Tablet	SY	00699692-532a-68fd-8a51-3770a81b2208	16
901555	pramipexole dihydrochloride 3 MG 24 HR Extended Release Oral Tablet	SY	00699692-532a-68fd-8a51-3770a81b2208	16
901534	pramipexole dihydrochloride 4.5 MG 24 HR Extended Release Oral Tablet	SY	00699692-532a-68fd-8a51-3770a81b2208	16
901546	pramipexole dihydrochloride 750 MCG 24 HR Extended Release Oral Tablet	SY	00699692-532a-68fd-8a51-3770a81b2208	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
55111-613-30	55111061330	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (55111-613-30)	2015-08-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pramipexole dihydrochloride	Dr. Reddy's Laboratories Limited \| Dr. Reddy's Laboratories Limited (FTO-III)	2021-08-31	HUMAN PRESCRIPTION DRUG LABEL	16