NUCYNTA

Product NDC: 21695-069
11-digit product format: 216950069
Labeler code: 21695
Product ID: 21695-069_7997e6da-7e98-4520-9d1b-0b8341bac64a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tapentadol hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Rebel Distributors Corp
Application: NDA022304
Marketing category: NDA
Marketing start: 2009-06-01
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: E
Listing certified through: 2017-12-31
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	21695-069		I	Inactivated by FDA		2026-08-11
excluded package	package	21695-069	21695-069-72	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 · 44 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	21695-069-72	`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	21695-069-72	`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	21695-069-72	`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	21695-069-72	`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	21695-069-72	`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	21695-069-72	`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	21695-069-72	`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	21695-069-72	`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	21695-069-72	`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	21695-069-72	`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	21695-069-72	`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	21695-069-72	`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	21695-069-72	`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	21695-069-72	`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	21695-069-72	`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	21695-069-72	`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	21695-069-72	`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	21695-069-72	`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	21695-069-72	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	21695-069-72	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	21695-069-72	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	21695-069-72	`110d247fa046…`	`a55b01930146…`

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
21695-069-72	2019-09-24	C162847	48780-1	934fe258-4a10-48b1-e053-8cdaa90a720a	These highlights do not include all the information needed to use NUCYNTA ® safely and effectively. See full prescribing information for NUCYNTA ® . NUCYNTA ® (tapentadol) immediate-release oral tablets C-II Initial U.S. Approval: 2008

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-069-72	NUCYNTA	120 in 1 BOTTLE	TABLET, FILM COATED	120		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-069-72	EA - Each	21695-069	b83f4008-f8ac-490f-a87e-19ff09d1b5d9	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
tapentadol hydrochloride	ACTIVE INGREDIENT	71204KII53	NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
tapentadol	ACTIVE MOIETY	H8A007M585	NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
aluminum oxide	INACTIVE INGREDIENT	LMI26O6933	NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
polyethylene glycol	INACTIVE INGREDIENT	3WJQ0SDW1A	NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
polyvinyl alcohol	INACTIVE INGREDIENT	532B59J990	NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
povidone	INACTIVE INGREDIENT	FZ989GH94E	NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
talc	INACTIVE INGREDIENT	7SEV7J4R1U	NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-069	NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 1 package rows	20110805_7997e6da-7e98-4520-9d1b-0b8341bac64a.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
854142	NUCYNTA 50 MG Oral Tablet	PSN	7997e6da-7e98-4520-9d1b-0b8341bac64a	1
825411	tapentadol 50 MG Oral Tablet	PSN	7997e6da-7e98-4520-9d1b-0b8341bac64a	1
854142	tapentadol 50 MG Oral Tablet [Nucynta]	SBD	7997e6da-7e98-4520-9d1b-0b8341bac64a	1
825411	tapentadol 50 MG Oral Tablet	SCD	7997e6da-7e98-4520-9d1b-0b8341bac64a	1
854142	Nucynta 50 MG Oral Tablet	SY	7997e6da-7e98-4520-9d1b-0b8341bac64a	1
825411	tapentadol 50 MG (as tapentadol hydrochloride) Oral Tablet	SY	7997e6da-7e98-4520-9d1b-0b8341bac64a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-069-72	21695006972	120 in 1 BOTTLE	Historical