Nucynta

Product NDC: 69865-210
11-digit product format: 698650210
Labeler code: 69865
Product ID: 69865-210_7134a790-af25-4843-bf3f-c768fac42fcf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tapentadol hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Depo NF Sub, LLC
Application: NDA022304
Marketing category: NDA
Marketing start: 2017-06-16
Marketing end: 0000-00-00
Substance: TAPENTADOL HYDROCHLORIDE
Active strength: 50 mg/1
Pharmacologic classes: Opioid Agonist [EPC],Opioid Agonists [MoA]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	69865-210		I	Inactivated by FDA	2026-08-11
excluded package	package	69865-210	69865-210-01	I	Inactivated by FDA	2026-08-11
excluded package	package	69865-210	69865-210-02	I	Inactivated by FDA	2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 57 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69865-210-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69865-210-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69865-210-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69865-210-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69865-210-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69865-210-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69865-210-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69865-210-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69865-210-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69865-210-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69865-210-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69865-210-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69865-210-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69865-210-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69865-210-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69865-210-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69865-210-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69865-210-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69865-210-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69865-210-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69865-210-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69865-210-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69865-210-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69865-210-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	69865-210-02	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	69865-210-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	69865-210-02	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	69865-210-01	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69865-210-02	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69865-210-01	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	69865-210-02	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	69865-210-01	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	69865-210-02	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	69865-210-01	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	69865-210-02	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	69865-210-01	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	69865-210-02	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	69865-210-01	`8dfbde2a14a4…`	`c9ff85d89658…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 123 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
2026-02-19 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…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022304-002	NUCYNTA	EQ 75MG BASE	TABLET / ORAL		RLD	2008-11-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022304-003	NUCYNTA	EQ 100MG BASE	TABLET / ORAL		RLD, RS	2008-11-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022304-001	NUCYNTA	EQ 50MG BASE	TABLET / ORAL		RLD	2008-11-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022304-002	NUCYNTA	EQ 75MG BASE	TABLET / ORAL		RLD	2008-11-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022304-003	NUCYNTA	EQ 100MG BASE	TABLET / ORAL		RLD, RS	2008-11-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022304-001	NUCYNTA	EQ 50MG BASE	TABLET / ORAL		RLD	2008-11-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022304-002	NUCYNTA	EQ 75MG BASE	TABLET / ORAL		RLD	2008-11-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022304-003	NUCYNTA	EQ 100MG BASE	TABLET / ORAL		RLD, RS	2008-11-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022304-001	NUCYNTA	EQ 50MG BASE	TABLET / ORAL		RLD	2008-11-20	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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 1 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
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022304-001	7994364	2025-06-27	U-931	Drug substance, Drug product	2011-09-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022304-001	7994364*PED	2025-12-27		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022304-002	7994364	2025-06-27	U-931	Drug substance, Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022304-002	7994364*PED	2025-12-27		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022304-003	7994364	2025-06-27	U-931	Drug substance, Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022304-003	7994364*PED	2025-12-27		Pediatric extension		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022304-001	7994364	2025-06-27	U-931	Drug substance, Drug product	2011-09-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022304-001	7994364*PED	2025-12-27		Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022304-002	7994364	2025-06-27	U-931	Drug substance, Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022304-002	7994364*PED	2025-12-27		Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022304-003	7994364	2025-06-27	U-931	Drug substance, Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022304-003	7994364*PED	2025-12-27		Pediatric extension		`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022304-001	7994364	2025-06-27	U-931	Drug substance, Drug product	2011-09-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022304-001	7994364*PED	2025-12-27		Pediatric extension		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022304-002	7994364	2025-06-27	U-931	Drug substance, Drug product		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022304-002	7994364*PED	2025-12-27		Pediatric extension		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022304-003	7994364	2025-06-27	U-931	Drug substance, Drug product		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022304-003	7994364*PED	2025-12-27		Pediatric extension		`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022304-001	7994364	2025-06-27	U-931	Drug substance, Drug product	2011-09-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022304-001	7994364*PED	2025-12-27		Pediatric extension		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022304-002	7994364	2025-06-27	U-931	Drug substance, Drug product		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022304-002	7994364*PED	2025-12-27		Pediatric extension		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022304-003	7994364	2025-06-27	U-931	Drug substance, Drug product		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022304-003	7994364*PED	2025-12-27		Pediatric extension		`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022304-001	7994364	2025-06-27	U-931	Drug substance, Drug product	2011-09-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022304-001	7994364*PED	2025-12-27		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022304-002	7994364	2025-06-27	U-931	Drug substance, Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022304-002	7994364*PED	2025-12-27		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022304-003	7994364	2025-06-27	U-931	Drug substance, Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022304-003	7994364*PED	2025-12-27		Pediatric extension		`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022304-001	7994364	2025-06-27	U-931	Drug substance, Drug product	2011-09-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022304-001	7994364*PED	2025-12-27		Pediatric extension		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022304-002	7994364	2025-06-27	U-931	Drug substance, Drug product		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022304-002	7994364*PED	2025-12-27		Pediatric extension		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022304-003	7994364	2025-06-27	U-931	Drug substance, Drug product		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022304-003	7994364*PED	2025-12-27		Pediatric extension		`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022304-001	7994364	2025-06-27	U-931	Drug substance, Drug product	2011-09-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022304-001	7994364*PED	2025-12-27		Pediatric extension		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022304-002	7994364	2025-06-27	U-931	Drug substance, Drug product		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022304-002	7994364*PED	2025-12-27		Pediatric extension		`5bbf6a4d5a75…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 96 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
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…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022304-003	NPP	2026-07-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022304-003	PED	2027-01-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022304-001	NPP	2026-07-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022304-001	PED	2027-01-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022304-002	NPP	2026-07-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022304-002	PED	2027-01-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022304-003	NPP	2026-07-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022304-003	PED	2027-01-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022304-001	NPP	2026-07-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022304-001	PED	2027-01-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022304-002	NPP	2026-07-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022304-002	PED	2027-01-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022304-003	NPP	2026-07-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022304-003	PED	2027-01-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022304-001	NPP	2026-07-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022304-001	PED	2027-01-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022304-002	NPP	2026-07-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022304-002	PED	2027-01-03	`2680178bc6a6…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
279f6ab2-ad0d-a4be-abc3-377fa3441fa2	Product name	1	20140508
41331914-7851-9471-14c3-fea0cf65689e	Product name	1	20140508
7142c439-ef45-40fb-d30b-dd20e4faf1c1	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69865-210-01	2021-01-29	C162847	48780-1	ba0f9c33-0f73-a910-e053-dadaa90a0b85	These highlights do not include all the information needed to use NUCYNTA ® TABLETS safely and effectively. See full prescribing information for NUCYNTA ® TABLETS. NUCYNTA ® (tapentadol) tablets for oral use C-II Initial U.S. Approval: 2008
69865-210-02	2021-01-29	C162847	48780-1	ba0f9c33-0f73-a910-e053-dadaa90a0b85	These highlights do not include all the information needed to use NUCYNTA ® TABLETS safely and effectively. See full prescribing information for NUCYNTA ® TABLETS. NUCYNTA ® (tapentadol) tablets for oral use C-II Initial U.S. Approval: 2008

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69865-210-01	Nucynta	10 in 1 CARTON	TABLET, FILM COATED	10	5
69865-210-01	Nucynta	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	5
69865-210-02	Nucynta	100 in 1 BOTTLE	TABLET, FILM COATED	100	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69865-210-02	EA - Each	69865-210	564485fa-bf8c-4b87-b0df-45ef61f29274	1	2017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69865-210	NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [DEPO NF SUB, LLC]	5	Legacy NDC, 3 package rows	20190223_ad05d6a0-addc-46e9-a5bd-7892b262b090.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 · 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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
71204KII53	TAPENTADOL HYDROCHLORIDE	175591-09-0	TAPENTADOL HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
854140	NUCYNTA 100 MG Oral Tablet	PSN	ad05d6a0-addc-46e9-a5bd-7892b262b090	5
854142	NUCYNTA 50 MG Oral Tablet	PSN	ad05d6a0-addc-46e9-a5bd-7892b262b090	5
854144	NUCYNTA 75 MG Oral Tablet	PSN	ad05d6a0-addc-46e9-a5bd-7892b262b090	5
825409	tapentadol 100 MG Oral Tablet	PSN	ad05d6a0-addc-46e9-a5bd-7892b262b090	5
825411	tapentadol 50 MG Oral Tablet	PSN	ad05d6a0-addc-46e9-a5bd-7892b262b090	5
825413	tapentadol 75 MG Oral Tablet	PSN	ad05d6a0-addc-46e9-a5bd-7892b262b090	5
854140	tapentadol 100 MG Oral Tablet [Nucynta]	SBD	ad05d6a0-addc-46e9-a5bd-7892b262b090	5
854142	tapentadol 50 MG Oral Tablet [Nucynta]	SBD	ad05d6a0-addc-46e9-a5bd-7892b262b090	5
854144	tapentadol 75 MG Oral Tablet [Nucynta]	SBD	ad05d6a0-addc-46e9-a5bd-7892b262b090	5
825409	tapentadol 100 MG Oral Tablet	SCD	ad05d6a0-addc-46e9-a5bd-7892b262b090	5
825411	tapentadol 50 MG Oral Tablet	SCD	ad05d6a0-addc-46e9-a5bd-7892b262b090	5
825413	tapentadol 75 MG Oral Tablet	SCD	ad05d6a0-addc-46e9-a5bd-7892b262b090	5
854140	Nucynta 100 MG Oral Tablet	SY	ad05d6a0-addc-46e9-a5bd-7892b262b090	5
854142	Nucynta 50 MG Oral Tablet	SY	ad05d6a0-addc-46e9-a5bd-7892b262b090	5
854144	Nucynta 75 MG Oral Tablet	SY	ad05d6a0-addc-46e9-a5bd-7892b262b090	5
825409	tapentadol 100 MG (as tapentadol hydrochloride) Oral Tablet	SY	ad05d6a0-addc-46e9-a5bd-7892b262b090	5
825411	tapentadol 50 MG (as tapentadol hydrochloride) Oral Tablet	SY	ad05d6a0-addc-46e9-a5bd-7892b262b090	5
825413	tapentadol 75 MG (as tapentadol hydrochloride) Oral Tablet	SY	ad05d6a0-addc-46e9-a5bd-7892b262b090	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
69865-210-01	69865021001	10 in 1 CARTON	Historical
69865-210-02	69865021002	100 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nucynta	Lake Erie Medical DBA Quality Care Products LLC	2019-03-14	HUMAN PRESCRIPTION DRUG LABEL	2
Nucynta	Depo NF Sub, LLC \| Janssen Pharmaceuticals, Inc. \| Janssen Ortho, LLC	2018-12-07	HUMAN PRESCRIPTION DRUG LABEL	5