Prucalopride

Product NDC: 70954-596
11-digit product format: 709540596
Labeler code: 70954
Product ID: 70954-596_a33b876a-c96e-4f3d-a1b8-56c4daa46892
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Prucalopride
Dosage form: TABLET
Route: ORAL
Labeler: ANI Pharmaceuticals, Inc.
Application: ANDA218492
Marketing category: ANDA
Marketing start: 2024-12-26
Substance: PRUCALOPRIDE SUCCINATE
Active strength: 1 mg/1
Pharmacologic classes: Serotonin 4 Receptor Agonists [MoA], Serotonin-4 Receptor 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A218492-001	PRUCALOPRIDE SUCCINATE	PRUCALOPRIDE SUCCINATE	EQ 1MG BASE	TABLET / ORAL	AB		2024-12-26
A218492-002	PRUCALOPRIDE SUCCINATE	PRUCALOPRIDE SUCCINATE	EQ 2MG BASE	TABLET / ORAL	AB		2024-12-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A218492-001	AB
A218492-002	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A218492-001	PRUCALOPRIDE SUCCINATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-12-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218492-002	PRUCALOPRIDE SUCCINATE	EQ 2MG BASE	TABLET / ORAL	AB	2024-12-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218492-001	PRUCALOPRIDE SUCCINATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-12-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218492-002	PRUCALOPRIDE SUCCINATE	EQ 2MG BASE	TABLET / ORAL	AB	2024-12-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218492-001	PRUCALOPRIDE SUCCINATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-12-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218492-002	PRUCALOPRIDE SUCCINATE	EQ 2MG BASE	TABLET / ORAL	AB	2024-12-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218492-001	PRUCALOPRIDE SUCCINATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-12-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218492-002	PRUCALOPRIDE SUCCINATE	EQ 2MG BASE	TABLET / ORAL	AB	2024-12-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218492-001	PRUCALOPRIDE SUCCINATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-12-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218492-002	PRUCALOPRIDE SUCCINATE	EQ 2MG BASE	TABLET / ORAL	AB	2024-12-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218492-001	PRUCALOPRIDE SUCCINATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-12-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218492-002	PRUCALOPRIDE SUCCINATE	EQ 2MG BASE	TABLET / ORAL	AB	2024-12-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218492-001	PRUCALOPRIDE SUCCINATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-12-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218492-002	PRUCALOPRIDE SUCCINATE	EQ 2MG BASE	TABLET / ORAL	AB	2024-12-26	`03ed91905a0d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218492-001	PRUCALOPRIDE SUCCINATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-12-26	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218492-002	PRUCALOPRIDE SUCCINATE	EQ 2MG BASE	TABLET / ORAL	AB	2024-12-26	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A218492-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218492-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218492-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218492-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218492-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218492-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218492-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218492-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218492-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218492-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218492-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218492-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218492-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218492-002	AB	1	`03ed91905a0d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218492-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218492-002	AB	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218492-001	CGT	2025-06-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218492-002	CGT	2025-06-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218492-001	CGT	2025-06-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218492-002	CGT	2025-06-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218492-001	CGT	2025-06-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218492-002	CGT	2025-06-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218492-001	CGT	2025-06-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218492-002	CGT	2025-06-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218492-001	CGT	2025-06-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218492-002	CGT	2025-06-24	`03ed91905a0d…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PRUCALOPRIDE SUCCINATE	1 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4V2G75E1CK	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2107345	Internal RxNorm lookup
2107353	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
6d82dfbd-f171-4045-9f7a-268e189a658a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c75476a7-e531-4d47-9c48-19159bd43a92	Product name	2	20251024

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70954-596-10	Prucalopride	30 in 1 BOTTLE	TABLET	30		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70954-596-10	EA - Each	70954-596	1db08e65-9034-498a-aba3-2dd2f3738e23	1	2025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70954-596	PRUCALOPRIDE TABLET [ANI PHARMACEUTICALS, INC.]	1	Current NDC, 1 package rows	20241229_6d82dfbd-f171-4045-9f7a-268e189a658a.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
Prucalopride	PRUCALOPRIDE	ANI Pharmaceuticals, Inc.	6d82dfbd-f171-4045-9f7a-268e189a658a	2025-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218492 application number: ANDA218492 ndc (product): 70954-596

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4V2G75E1CK	PRUCALOPRIDE SUCCINATE	179474-85-2	PRUCALOPRIDE SUCCINATE
0A09IUW5TP	PRUCALOPRIDE	179474-81-8	Prucalopride

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2107345	prucalopride 1 MG Oral Tablet	PSN	6d82dfbd-f171-4045-9f7a-268e189a658a	2
2107353	prucalopride 2 MG Oral Tablet	PSN	6d82dfbd-f171-4045-9f7a-268e189a658a	2
2107345	prucalopride 1 MG Oral Tablet	SCD	6d82dfbd-f171-4045-9f7a-268e189a658a	2
2107353	prucalopride 2 MG Oral Tablet	SCD	6d82dfbd-f171-4045-9f7a-268e189a658a	2
2107345	prucalopride 1 MG (equivalent to prucalopride succinate 1.32 MG) Oral Tablet	SY	6d82dfbd-f171-4045-9f7a-268e189a658a	2
2107353	prucalopride 2 MG (equivalent to prucalopride succinate 2.64 MG) Oral Tablet	SY	6d82dfbd-f171-4045-9f7a-268e189a658a	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70954-596-10	70954059610	30 TABLET in 1 BOTTLE (70954-596-10)	30 tablet	2024-12-26	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Prucalopride	ANI Pharmaceuticals, Inc. \| Novitium Pharma LLC	2025-12-05	Human Prescription Drug Label	2