Nucynta

Product NDC: 69865-250
11-digit product format: 698650250
Labeler code: 69865
Product ID: 69865-250_48a5c0ae-e4e1-47ad-bfc5-3d56558e0cba
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tapentadol hydrochloride
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Depo NF Sub, LLC
Application: NDA200533
Marketing category: NDA
Marketing start: 2017-06-16
Marketing end: 0000-00-00
Substance: TAPENTADOL HYDROCHLORIDE
Active strength: 150 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	69865-250		I	Inactivated by FDA	2026-08-11
excluded package	package	69865-250	69865-250-01	I	Inactivated by FDA	2026-08-11
excluded package	package	69865-250	69865-250-02	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	69865-250-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69865-250-02	`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	69865-250-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69865-250-02	`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	69865-250-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69865-250-02	`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	69865-250-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69865-250-02	`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	69865-250-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69865-250-02	`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	69865-250-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69865-250-02	`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	69865-250-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69865-250-02	`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	69865-250-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69865-250-02	`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	69865-250-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69865-250-02	`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	69865-250-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69865-250-02	`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	69865-250-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69865-250-02	`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	69865-250-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69865-250-02	`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	69865-250-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	69865-250-02	`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	69865-250-01	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	69865-250-02	`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	69865-250-01	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69865-250-02	`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	69865-250-02	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	69865-250-01	`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	69865-250-02	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	69865-250-01	`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	69865-250-02	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	69865-250-01	`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	69865-250-02	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	69865-250-01	`8dfbde2a14a4…`	`c9ff85d89658…`

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N200533-001	NUCYNTA ER	TAPENTADOL HYDROCHLORIDE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25
N200533-002	NUCYNTA ER	TAPENTADOL HYDROCHLORIDE	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25
N200533-003	NUCYNTA ER	TAPENTADOL HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25
N200533-004	NUCYNTA ER	TAPENTADOL HYDROCHLORIDE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25
N200533-005	NUCYNTA ER	TAPENTADOL HYDROCHLORIDE	EQ 250MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-08-25

Orange Book patents#

Current patent rows page 1 of 1 · 25 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N200533-001	11344512	2028-04-21	U-3391		2022-06-29
N200533-001	11344512	2028-04-21	U-3392		2022-06-29
N200533-001	8536130	2028-09-22	U-1276
N200533-001	11344512*PED	2028-10-21		Pediatric extension
N200533-001	8536130*PED	2029-03-22		Pediatric extension
N200533-002	11344512	2028-04-21	U-3391		2022-06-29
N200533-002	11344512	2028-04-21	U-3392		2022-06-29
N200533-002	8536130	2028-09-22	U-1276
N200533-002	11344512*PED	2028-10-21		Pediatric extension
N200533-002	8536130*PED	2029-03-22		Pediatric extension
N200533-003	11344512	2028-04-21	U-3391		2022-06-29
N200533-003	11344512	2028-04-21	U-3392		2022-06-29
N200533-003	8536130	2028-09-22	U-1276
N200533-003	11344512*PED	2028-10-21		Pediatric extension
N200533-003	8536130*PED	2029-03-22		Pediatric extension
N200533-004	11344512	2028-04-21	U-3391		2022-06-29
N200533-004	11344512	2028-04-21	U-3392		2022-06-29
N200533-004	8536130	2028-09-22	U-1276
N200533-004	11344512*PED	2028-10-21		Pediatric extension
N200533-004	8536130*PED	2029-03-22		Pediatric extension
N200533-005	11344512	2028-04-21	U-3391		2022-06-29
N200533-005	11344512	2028-04-21	U-3392		2022-06-29
N200533-005	8536130	2028-09-22	U-1276
N200533-005	11344512*PED	2028-10-21		Pediatric extension
N200533-005	8536130*PED	2029-03-22		Pediatric extension

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 · 205 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N200533-001	NUCYNTA ER	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-002	NUCYNTA ER	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-003	NUCYNTA ER	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-004	NUCYNTA ER	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-005	NUCYNTA ER	EQ 250MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-08-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200533-001	NUCYNTA ER	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200533-002	NUCYNTA ER	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200533-003	NUCYNTA ER	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200533-004	NUCYNTA ER	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200533-005	NUCYNTA ER	EQ 250MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-08-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N200533-001	NUCYNTA ER	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200533-002	NUCYNTA ER	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200533-003	NUCYNTA ER	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200533-004	NUCYNTA ER	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200533-005	NUCYNTA ER	EQ 250MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-08-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200533-001	NUCYNTA ER	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200533-002	NUCYNTA ER	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200533-003	NUCYNTA ER	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200533-004	NUCYNTA ER	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200533-005	NUCYNTA ER	EQ 250MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-08-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200533-001	NUCYNTA ER	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200533-002	NUCYNTA ER	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200533-003	NUCYNTA ER	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200533-004	NUCYNTA ER	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200533-005	NUCYNTA ER	EQ 250MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-08-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200533-001	NUCYNTA ER	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200533-002	NUCYNTA ER	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200533-003	NUCYNTA ER	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200533-004	NUCYNTA ER	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200533-005	NUCYNTA ER	EQ 250MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-08-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200533-001	NUCYNTA ER	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200533-002	NUCYNTA ER	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200533-003	NUCYNTA ER	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200533-004	NUCYNTA ER	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200533-005	NUCYNTA ER	EQ 250MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-08-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200533-001	NUCYNTA ER	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200533-002	NUCYNTA ER	EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200533-003	NUCYNTA ER	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200533-004	NUCYNTA ER	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-08-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200533-005	NUCYNTA ER	EQ 250MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-08-25	`5bbf6a4d5a75…`

Observed Orange Book patent history#

Patent history page 1 of 50 · 1,980 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N200533-001	11344512	2028-04-21	U-3391		2022-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-001	11344512	2028-04-21	U-3392		2022-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-001	8536130	2028-09-22	U-1276			`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-001	11344512*PED	2028-10-21		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-001	8536130*PED	2029-03-22		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-002	11344512	2028-04-21	U-3392		2022-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-002	11344512	2028-04-21	U-3391		2022-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-002	8536130	2028-09-22	U-1276			`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-002	11344512*PED	2028-10-21		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-002	8536130*PED	2029-03-22		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-003	11344512	2028-04-21	U-3392		2022-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-003	11344512	2028-04-21	U-3391		2022-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-003	8536130	2028-09-22	U-1276			`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-003	11344512*PED	2028-10-21		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-003	8536130*PED	2029-03-22		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-004	11344512	2028-04-21	U-3392		2022-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-004	11344512	2028-04-21	U-3391		2022-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-004	8536130	2028-09-22	U-1276			`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-004	11344512*PED	2028-10-21		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-004	8536130*PED	2029-03-22		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-005	11344512	2028-04-21	U-3392		2022-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-005	11344512	2028-04-21	U-3391		2022-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-005	8536130	2028-09-22	U-1276			`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-005	11344512*PED	2028-10-21		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200533-005	8536130*PED	2029-03-22		Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200533-001	7994364	2025-06-27	U-1276	Drug substance, Drug product	2011-09-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200533-001	7994364	2025-06-27	U-1178	Drug substance, Drug product	2011-09-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200533-001	7994364*PED	2025-12-27		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200533-001	11344512	2028-04-21	U-3391		2022-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200533-001	11344512	2028-04-21	U-3392		2022-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200533-001	8536130	2028-09-22	U-1276			`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200533-001	11344512*PED	2028-10-21		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200533-001	8536130*PED	2029-03-22		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200533-002	7994364	2025-06-27	U-1178	Drug substance, Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200533-002	7994364	2025-06-27	U-1276	Drug substance, Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200533-002	7994364*PED	2025-12-27		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200533-002	11344512	2028-04-21	U-3392		2022-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200533-002	11344512	2028-04-21	U-3391		2022-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200533-002	8536130	2028-09-22	U-1276			`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200533-002	11344512*PED	2028-10-21		Pediatric extension		`31067a03dcf5…`

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
69865-250-01	2021-01-29	C162847	48780-1	ba0f9c33-4df9-a910-e053-dadaa90a0b85	These highlights do not include all the information needed to use NUCYNTA ® ER safely and effectively. See full prescribing information for NUCYNTA ® ER NUCYNTA ® ER (tapentadol) extended-release tablets for oral use C-II Initial U.S. Approval: 2008
69865-250-02	2021-01-29	C162847	48780-1	ba0f9c33-4df9-a910-e053-dadaa90a0b85	These highlights do not include all the information needed to use NUCYNTA ® ER safely and effectively. See full prescribing information for NUCYNTA ® ER NUCYNTA ® ER (tapentadol) extended-release 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
69865-250-01	NucyntaER	10 in 1 CARTON	TABLET, FILM COATED, EXTENDED RE	10	5
69865-250-01	NucyntaER	10 in 1 BLISTER PACK	TABLET, FILM COATED, EXTENDED RE	10	5
69865-250-02	NucyntaER	60 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	60	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69865-250-02	EA - Each	69865-250	c61dc3ac-45dc-4b28-a3de-b03f75721aa1	1	2017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69865-250	NUCYNTA ER (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DEPO NF SUB, LLC]	5	Legacy NDC, 3 package rows	20190223_40671852-846e-4bc1-8e15-1f71add24414.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.	38de863e-56ff-4c43-9ab8-9b3e1ba82858	2026-02-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 200533 application number: NDA200533
Nucynta ER	TAPENTADOL HYDROCHLORIDE	Collegium Pharmaceutical, Inc.	c3d04d70-0155-4147-9ce4-a3b1fad4b373	2025-12-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 200533 application number: NDA200533

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
1149367	Nucynta ER 100 MG 12HR Extended Release Oral Tablet	PSN	40671852-846e-4bc1-8e15-1f71add24414	5
1149370	Nucynta ER 150 MG 12HR Extended Release Oral Tablet	PSN	40671852-846e-4bc1-8e15-1f71add24414	5
1149373	Nucynta ER 200 MG 12HR Extended Release Oral Tablet	PSN	40671852-846e-4bc1-8e15-1f71add24414	5
1149376	Nucynta ER 250 MG 12HR Extended Release Oral Tablet	PSN	40671852-846e-4bc1-8e15-1f71add24414	5
1149378	Nucynta ER 50 MG 12HR Extended Release Oral Tablet	PSN	40671852-846e-4bc1-8e15-1f71add24414	5
1148797	tapentadol 100 MG 12HR Extended Release Oral Tablet	PSN	40671852-846e-4bc1-8e15-1f71add24414	5
1148800	tapentadol 150 MG 12HR Extended Release Oral Tablet	PSN	40671852-846e-4bc1-8e15-1f71add24414	5
1148803	tapentadol 200 MG 12HR Extended Release Oral Tablet	PSN	40671852-846e-4bc1-8e15-1f71add24414	5
1148807	tapentadol 250 MG 12HR Extended Release Oral Tablet	PSN	40671852-846e-4bc1-8e15-1f71add24414	5
1148809	tapentadol 50 MG 12HR Extended Release Oral Tablet	PSN	40671852-846e-4bc1-8e15-1f71add24414	5
1149367	12 HR tapentadol 100 MG Extended Release Oral Tablet [Nucynta]	SBD	40671852-846e-4bc1-8e15-1f71add24414	5
1149370	12 HR tapentadol 150 MG Extended Release Oral Tablet [Nucynta]	SBD	40671852-846e-4bc1-8e15-1f71add24414	5
1149373	12 HR tapentadol 200 MG Extended Release Oral Tablet [Nucynta]	SBD	40671852-846e-4bc1-8e15-1f71add24414	5
1149376	12 HR tapentadol 250 MG Extended Release Oral Tablet [Nucynta]	SBD	40671852-846e-4bc1-8e15-1f71add24414	5
1149378	12 HR tapentadol 50 MG Extended Release Oral Tablet [Nucynta]	SBD	40671852-846e-4bc1-8e15-1f71add24414	5
1148797	12 HR tapentadol 100 MG Extended Release Oral Tablet	SCD	40671852-846e-4bc1-8e15-1f71add24414	5
1148800	12 HR tapentadol 150 MG Extended Release Oral Tablet	SCD	40671852-846e-4bc1-8e15-1f71add24414	5
1148803	12 HR tapentadol 200 MG Extended Release Oral Tablet	SCD	40671852-846e-4bc1-8e15-1f71add24414	5
1148807	12 HR tapentadol 250 MG Extended Release Oral Tablet	SCD	40671852-846e-4bc1-8e15-1f71add24414	5
1148809	12 HR tapentadol 50 MG Extended Release Oral Tablet	SCD	40671852-846e-4bc1-8e15-1f71add24414	5
1149367	12 HR Nucynta 100 MG Extended Release Oral Tablet	SY	40671852-846e-4bc1-8e15-1f71add24414	5
1149370	12 HR Nucynta 150 MG Extended Release Oral Tablet	SY	40671852-846e-4bc1-8e15-1f71add24414	5
1149373	12 HR Nucynta 200 MG Extended Release Oral Tablet	SY	40671852-846e-4bc1-8e15-1f71add24414	5
1149376	12 HR Nucynta 250 MG Extended Release Oral Tablet	SY	40671852-846e-4bc1-8e15-1f71add24414	5
1149378	12 HR Nucynta 50 MG Extended Release Oral Tablet	SY	40671852-846e-4bc1-8e15-1f71add24414	5
1149367	Nucynta 100 MG (tapentadol hydrochloride 116.48 MG) 12 HR Extended Release Oral Tablet	SY	40671852-846e-4bc1-8e15-1f71add24414	5
1149370	Nucynta 150 MG (tapentadol hydrochloride 174.72 MG) 12 HR Extended Release Oral Tablet	SY	40671852-846e-4bc1-8e15-1f71add24414	5
1149373	Nucynta 200 MG (tapentadol hydrochloride 232.96 MG) 12 HR Extended Release Oral Tablet	SY	40671852-846e-4bc1-8e15-1f71add24414	5
1149376	Nucynta 250 MG (tapentadol hydrochloride 291.20 MG) 12 HR Extended Release Oral Tablet	SY	40671852-846e-4bc1-8e15-1f71add24414	5
1149378	Nucynta 50 MG (tapentadol hydrochloride 58.24 MG) 12 HR Extended Release Oral Tablet	SY	40671852-846e-4bc1-8e15-1f71add24414	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
69865-250-01	69865025001	10 in 1 CARTON	Historical
69865-250-02	69865025002	60 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nucynta ER	Depo NF Sub, LLC \| Janssen Pharmaceuticals, Inc. \| Janssen Ortho, LLC	2018-10-22	HUMAN PRESCRIPTION DRUG LABEL	5