Nucynta

Product NDC: 55700-797
11-digit product format: 557000797
Labeler code: 55700
Product ID: 55700-797_df84549d-352e-483f-b5f5-0e50e09c762e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tapentadol hydrochloride
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Quality Care Products, LLC
Application: NDA200533
Marketing category: NDA
Marketing start: 2019-09-27
Marketing end: 0000-00-00
Substance: TAPENTADOL HYDROCHLORIDE
Active strength: 100 mg/1
Pharmacologic classes: Opioid Agonist [EPC],Opioid Agonists [MoA]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	55700-797		D	Discontinued by firm		2026-08-11
excluded package	package	55700-797	55700-797-60	D	Discontinued by firm		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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55700-797-60	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55700-797-60	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55700-797-60	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55700-797-60	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55700-797-60	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55700-797-60	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55700-797-60	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55700-797-60	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55700-797-60	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55700-797-60	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55700-797-60	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55700-797-60	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	55700-797-60	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	55700-797-60	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	55700-797-60	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

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…`

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2025-01-08	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
2023-01-30	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
2021-06-04	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
2021-01-29	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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55700-797-60	EA - Each	55700-797	e494c61a-96f8-48db-b6f9-b614277a7012	1	2019-11-12

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
55700-797-60	55700079760	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55700-797-60)	2019-09-27	0000-00-00	No	No	Current