Prucalopride

Product NDC: 70954-596
11-digit product format: 709540596
Labeler code: 70954
Product ID: 70954-596_d2e14111-1b54-48f1-974f-37d54a0c2bf5
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: 2027-12-31
Current FDA listing: Yes

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

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
2026-10-15 13:18:30	2026-09	A218492-001	PRUCALOPRIDE SUCCINATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-12-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A218492-002	PRUCALOPRIDE SUCCINATE	EQ 2MG BASE	TABLET / ORAL	AB	2024-12-26	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A218492-001	PRUCALOPRIDE SUCCINATE	EQ 1MG BASE	TABLET / ORAL	AB	2024-12-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218492-002	PRUCALOPRIDE SUCCINATE	EQ 2MG BASE	TABLET / ORAL	AB	2024-12-26	`84e616aacf4f…`
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
2026-10-15 13:18:30	2026-09	A218492-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A218492-002	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A218492-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218492-002	AB	1	`84e616aacf4f…`
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…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

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

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

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	2026-07-22	Human Prescription Drug Label	3