Application 022304

Type: NDA
Sponsor: COLLEGIUM PHARM INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NUCYNTA	TAPENTADOL HYDROCHLORIDE	TABLET;ORAL	EQ 50MG BASE	Yes	No
002	NUCYNTA	TAPENTADOL HYDROCHLORIDE	TABLET;ORAL	EQ 75MG BASE	Yes	No
003	NUCYNTA	TAPENTADOL HYDROCHLORIDE	TABLET;ORAL	EQ 100MG BASE	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022304-001	NUCYNTA	TAPENTADOL HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	RLD	2008-11-20
N022304-002	NUCYNTA	TAPENTADOL HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB	RLD	2008-11-20
N022304-003	NUCYNTA	TAPENTADOL HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	RLD, RS	2008-11-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N022304-001	AB
N022304-002	AB
N022304-003	AB

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N022304-001	NPP	2026-07-03
N022304-001	PED	2027-01-03
N022304-002	NPP	2026-07-03
N022304-002	PED	2027-01-03
N022304-003	NPP	2026-07-03
N022304-003	PED	2027-01-03

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 4 · 132 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
2026-10-15 13:18:30	2026-09	N022304-001	NUCYNTA	EQ 50MG BASE	TABLET / ORAL	AB	RLD	2008-11-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022304-002	NUCYNTA	EQ 75MG BASE	TABLET / ORAL	AB	RLD	2008-11-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022304-003	NUCYNTA	EQ 100MG BASE	TABLET / ORAL	AB	RLD, RS	2008-11-20	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N022304-001	NUCYNTA	EQ 50MG BASE	TABLET / ORAL	AB	RLD	2008-11-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022304-002	NUCYNTA	EQ 75MG BASE	TABLET / ORAL	AB	RLD	2008-11-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022304-003	NUCYNTA	EQ 100MG BASE	TABLET / ORAL	AB	RLD, RS	2008-11-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022304-001	NUCYNTA	EQ 50MG BASE	TABLET / ORAL	AB	RLD	2008-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022304-002	NUCYNTA	EQ 75MG BASE	TABLET / ORAL	AB	RLD	2008-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022304-003	NUCYNTA	EQ 100MG BASE	TABLET / ORAL	AB	RLD, RS	2008-11-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022304-001	NUCYNTA	EQ 50MG BASE	TABLET / ORAL	AB	RLD	2008-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022304-002	NUCYNTA	EQ 75MG BASE	TABLET / ORAL	AB	RLD	2008-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022304-003	NUCYNTA	EQ 100MG BASE	TABLET / ORAL	AB	RLD, RS	2008-11-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022304-001	NUCYNTA	EQ 50MG BASE	TABLET / ORAL		RLD	2008-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022304-002	NUCYNTA	EQ 75MG BASE	TABLET / ORAL		RLD	2008-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022304-003	NUCYNTA	EQ 100MG BASE	TABLET / ORAL		RLD, RS	2008-11-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022304-001	NUCYNTA	EQ 50MG BASE	TABLET / ORAL		RLD	2008-11-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022304-002	NUCYNTA	EQ 75MG BASE	TABLET / ORAL		RLD	2008-11-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022304-003	NUCYNTA	EQ 100MG BASE	TABLET / ORAL		RLD, RS	2008-11-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022304-001	NUCYNTA	EQ 50MG BASE	TABLET / ORAL		RLD	2008-11-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022304-002	NUCYNTA	EQ 75MG BASE	TABLET / ORAL		RLD	2008-11-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022304-003	NUCYNTA	EQ 100MG BASE	TABLET / ORAL		RLD, RS	2008-11-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022304-001	NUCYNTA	EQ 50MG BASE	TABLET / ORAL		RLD	2008-11-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022304-002	NUCYNTA	EQ 75MG BASE	TABLET / ORAL		RLD	2008-11-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022304-003	NUCYNTA	EQ 100MG BASE	TABLET / ORAL		RLD, RS	2008-11-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022304-001	NUCYNTA	EQ 50MG BASE	TABLET / ORAL		RLD	2008-11-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022304-002	NUCYNTA	EQ 75MG BASE	TABLET / ORAL		RLD	2008-11-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022304-003	NUCYNTA	EQ 100MG BASE	TABLET / ORAL		RLD, RS	2008-11-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022304-001	NUCYNTA	EQ 50MG BASE	TABLET / ORAL		RLD	2008-11-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022304-002	NUCYNTA	EQ 75MG BASE	TABLET / ORAL		RLD	2008-11-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022304-003	NUCYNTA	EQ 100MG BASE	TABLET / ORAL		RLD, RS	2008-11-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022304-001	NUCYNTA	EQ 50MG BASE	TABLET / ORAL		RLD	2008-11-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022304-002	NUCYNTA	EQ 75MG BASE	TABLET / ORAL		RLD	2008-11-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022304-003	NUCYNTA	EQ 100MG BASE	TABLET / ORAL		RLD, RS	2008-11-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022304-001	NUCYNTA	EQ 50MG BASE	TABLET / ORAL		RLD	2008-11-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022304-002	NUCYNTA	EQ 75MG BASE	TABLET / ORAL		RLD	2008-11-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022304-003	NUCYNTA	EQ 100MG BASE	TABLET / ORAL		RLD, RS	2008-11-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022304-001	NUCYNTA	EQ 50MG BASE	TABLET / ORAL		RLD	2008-11-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022304-002	NUCYNTA	EQ 75MG BASE	TABLET / ORAL		RLD	2008-11-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022304-003	NUCYNTA	EQ 100MG BASE	TABLET / ORAL		RLD, RS	2008-11-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022304-001	NUCYNTA	EQ 50MG BASE	TABLET / ORAL		RLD	2008-11-20	`79d66fd596c7…`

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	N022304-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022304-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022304-003	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N022304-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022304-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022304-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022304-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022304-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022304-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022304-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022304-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022304-003	AB	1	`011fe1cb6892…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022304-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022304-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022304-003	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 2 of 6 · 201 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022304-003	7994364	2025-06-27	U-931	Drug substance, Drug product		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022304-003	7994364*PED	2025-12-27		Pediatric extension		`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022304-001	7994364	2025-06-27	U-931	Drug substance, Drug product	2011-09-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022304-001	7994364*PED	2025-12-27		Pediatric extension		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022304-002	7994364	2025-06-27	U-931	Drug substance, Drug product		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022304-002	7994364*PED	2025-12-27		Pediatric extension		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022304-003	7994364	2025-06-27	U-931	Drug substance, Drug product		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022304-003	7994364*PED	2025-12-27		Pediatric extension		`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022304-001	7994364	2025-06-27	U-931	Drug substance, Drug product	2011-09-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022304-001	7994364*PED	2025-12-27		Pediatric extension		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022304-002	7994364	2025-06-27	U-931	Drug substance, Drug product		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022304-002	7994364*PED	2025-12-27		Pediatric extension		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022304-003	7994364	2025-06-27	U-931	Drug substance, Drug product		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022304-003	7994364*PED	2025-12-27		Pediatric extension		`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022304-001	7994364	2025-06-27	U-931	Drug substance, Drug product	2011-09-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022304-001	7994364*PED	2025-12-27		Pediatric extension		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022304-002	7994364	2025-06-27	U-931	Drug substance, Drug product		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022304-002	7994364*PED	2025-12-27		Pediatric extension		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022304-003	7994364	2025-06-27	U-931	Drug substance, Drug product		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022304-003	7994364*PED	2025-12-27		Pediatric extension		`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022304-001	7994364	2025-06-27	U-931	Drug substance, Drug product	2011-09-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022304-002	7994364	2025-06-27	U-931	Drug substance, Drug product		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022304-003	7994364	2025-06-27	U-931	Drug substance, Drug product		`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022304-001	7994364	2025-06-27	U-931	Drug substance, Drug product	2011-09-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022304-002	7994364	2025-06-27	U-931	Drug substance, Drug product		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022304-003	7994364	2025-06-27	U-931	Drug substance, Drug product		`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022304-001	7994364	2025-06-27	U-931	Drug substance, Drug product	2011-09-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022304-002	7994364	2025-06-27	U-931	Drug substance, Drug product		`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022304-003	7994364	2025-06-27	U-931	Drug substance, Drug product		`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022304-001	RE39593	2022-08-05	U-931	Drug substance, Drug product	2011-07-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022304-001	7994364	2025-06-27	U-931	Drug substance, Drug product	2011-09-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022304-002	RE39593	2022-08-05	U-931	Drug substance, Drug product	2011-07-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022304-002	7994364	2025-06-27	U-931	Drug substance, Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022304-003	RE39593	2022-08-05	U-931	Drug substance, Drug product	2011-07-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022304-003	7994364	2025-06-27	U-931	Drug substance, Drug product		`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022304-001	RE39593	2022-08-05	U-931	Drug substance, Drug product	2011-07-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022304-001	7994364	2025-06-27	U-931	Drug substance, Drug product	2011-09-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022304-002	RE39593	2022-08-05	U-931	Drug substance, Drug product	2011-07-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022304-002	7994364	2025-06-27	U-931	Drug substance, Drug product		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022304-003	RE39593	2022-08-05	U-931	Drug substance, Drug product	2011-07-21	`5d02ea3f76ae…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 114 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-10-15 13:18:30	2026-09	N022304-001	NPP	2026-07-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022304-001	PED	2027-01-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022304-002	NPP	2026-07-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022304-002	PED	2027-01-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022304-003	NPP	2026-07-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022304-003	PED	2027-01-03	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N022304-001	NPP	2026-07-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022304-001	PED	2027-01-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022304-002	NPP	2026-07-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022304-002	PED	2027-01-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022304-003	NPP	2026-07-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022304-003	PED	2027-01-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022304-001	NPP	2026-07-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022304-001	PED	2027-01-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022304-002	NPP	2026-07-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022304-002	PED	2027-01-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022304-003	NPP	2026-07-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022304-003	PED	2027-01-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022304-001	NPP	2026-07-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022304-001	PED	2027-01-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022304-002	NPP	2026-07-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022304-002	PED	2027-01-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022304-003	NPP	2026-07-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022304-003	PED	2027-01-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022304-001	NPP	2026-07-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022304-001	PED	2027-01-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022304-002	NPP	2026-07-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022304-002	PED	2027-01-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022304-003	NPP	2026-07-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022304-003	PED	2027-01-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022304-001	NPP	2026-07-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022304-001	PED	2027-01-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022304-002	NPP	2026-07-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022304-002	PED	2027-01-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022304-003	NPP	2026-07-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022304-003	PED	2027-01-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022304-001	NPP	2026-07-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022304-001	PED	2027-01-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022304-002	NPP	2026-07-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022304-002	PED	2027-01-03	`fd3edfee7708…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TAPENTADOL	TAPENTADOL HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	863f3fd3-1e8d-41b0-855f-8f9a29237cda	2026-02-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022304 application number: NDA022304
Nucynta	TAPENTADOL HYDROCHLORIDE	Collegium Pharmaceutical, Inc.	80938c30-9fe3-4c7d-9d9c-5476638cfb2d	2025-12-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022304 application number: NDA022304 ndc (product): 24510-050 ndc (product): 24510-075 ndc (product): 24510-100

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
21695-069	NUCYNTA	tapentadol hydrochloride	Rebel Distributors Corp	NDA	Current
24510-050	Nucynta	tapentadol hydrochloride	Collegium Pharmaceutical, Inc.	NDA	Current
24510-050	Nucynta	tapentadol hydrochloride	Collegium Pharmaceutical, Inc.	NDA	Current
24510-050	Nucynta	tapentadol hydrochloride	Collegium Pharmaceutical, Inc.	NDA	Current
24510-075	Nucynta	tapentadol hydrochloride	Collegium Pharmaceutical, Inc.	NDA	Current
24510-075	Nucynta	tapentadol hydrochloride	Collegium Pharmaceutical, Inc.	NDA	Current
24510-075	Nucynta	tapentadol hydrochloride	Collegium Pharmaceutical, Inc.	NDA	Current
24510-100	Nucynta	tapentadol hydrochloride	Collegium Pharmaceutical, Inc.	NDA	Current
24510-100	Nucynta	tapentadol hydrochloride	Collegium Pharmaceutical, Inc.	NDA	Current
24510-100	Nucynta	tapentadol hydrochloride	Collegium Pharmaceutical, Inc.	NDA	Current
35356-525	Nucynta	Tapentadol hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	NDA	Current
35356-593	NUCYNTA	tapentadol hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	NDA	Current
35356-611	NUCYNTA	tapentadol hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	NDA	Current
50458-820	NUCYNTA	tapentadol hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-830	NUCYNTA	tapentadol hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-840	NUCYNTA	tapentadol hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
55700-606	Nucynta	tapentadol hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	NDA	Current
55700-792	Nucynta	tapentadol hydrochloride	Quality Care Products, LLC	NDA	Current
69865-210	Nucynta	tapentadol hydrochloride	Depo NF Sub, LLC	NDA	Current
69865-220	Nucynta	tapentadol hydrochloride	Depo NF Sub, LLC	NDA	Current
69865-230	Nucynta	tapentadol hydrochloride	Depo NF Sub, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84532	SUPPL	2025-12-31
84526	SUPPL	2025-12-23
80075	SUPPL	2024-11-04
78827	SUPPL	2024-06-18
78826	SUPPL	2024-06-18
78810	SUPPL	2024-06-18
77032	SUPPL	2023-12-19
76939	SUPPL	2023-12-18
76237	ORIG	2023-11-03
74694	SUPPL	2023-07-06
74689	SUPPL	2023-07-05
66631	SUPPL	2021-03-08
66630	SUPPL	2021-03-08
66559	SUPPL	2021-03-05
60388	SUPPL	2019-10-08
60384	SUPPL	2019-10-08
60383	SUPPL	2019-10-08
55773	SUPPL	2018-10-01
55772	SUPPL	2018-10-01
55771	SUPPL	2018-10-01
55685	SUPPL	2018-10-01
55684	SUPPL	2018-10-01
46624	SUPPL	2016-12-30
46340	SUPPL	2016-12-21
46331	SUPPL	2016-12-21
29557	SUPPL	2013-11-06
7206	SUPPL	2013-11-06
38537	SUPPL	2013-11-01
17218	SUPPL	2013-11-01
38536	SUPPL	2013-07-12
38535	SUPPL	2013-07-12
38534	SUPPL	2013-07-12
29556	SUPPL	2013-07-12
29555	SUPPL	2013-07-12
29554	SUPPL	2013-07-12
17217	SUPPL	2013-07-12
17216	SUPPL	2013-07-12
7205	SUPPL	2013-07-12
7204	SUPPL	2013-07-12
29553	SUPPL	2010-11-04
7203	SUPPL	2010-11-04
38533	SUPPL	2010-11-01
17215	SUPPL	2010-11-01
29552	SUPPL	2010-01-20
38532	SUPPL	2009-11-16
17214	ORIG	2009-02-04
29551	ORIG	2009-01-25
24278	ORIG	2009-01-25
21988	ORIG	2009-01-25