NUCYNTA

Product NDC: 35356-611
11-digit product format: 353560611
Labeler code: 35356
Product ID: 35356-611_e51890f2-dee6-42e7-9f8f-546865922a8d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tapentadol hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Lake Erie Medical DBA Quality Care Products LLC
Application: NDA022304
Marketing category: NDA
Marketing start: 2009-06-01
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: 2019-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	35356-611		D	Discontinued by firm	2026-08-11
excluded package	package	35356-611	35356-611-30	D	Discontinued by firm	2026-08-11
excluded package	package	35356-611	35356-611-60	D	Discontinued by firm	2026-08-11
excluded package	package	35356-611	35356-611-90	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 · 48 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	35356-611-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	35356-611-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	35356-611-30	`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	35356-611-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	35356-611-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	35356-611-30	`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	35356-611-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	35356-611-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	35356-611-30	`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	35356-611-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	35356-611-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	35356-611-30	`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	35356-611-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	35356-611-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	35356-611-30	`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	35356-611-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	35356-611-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	35356-611-30	`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	35356-611-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	35356-611-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	35356-611-30	`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	35356-611-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	35356-611-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	35356-611-30	`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	35356-611-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	35356-611-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	35356-611-30	`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	35356-611-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	35356-611-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	35356-611-30	`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	35356-611-60	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	35356-611-90	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	35356-611-30	`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	35356-611-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	35356-611-90	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	35356-611-30	`557ba5c1ecfa…`	`9c80585c8c6e…`

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
35356-611-30	EA - Each	35356-611	75607ebb-5bdc-4c18-b14e-f79a928baa31	1	2013-02-13
35356-611-60	EA - Each	35356-611	35ca51d1-fa93-4cdd-b23b-56e99a865935	1	2013-02-13
35356-611-90	EA - Each	35356-611	77c2bfad-deab-4894-9f50-701d0aeef954	1	2013-02-13

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