Application 020281

Type: NDA
Sponsor: JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ULTRAM	TRAMADOL HYDROCHLORIDE	TABLET;ORAL	100MG	No	No
002	ULTRAM	TRAMADOL HYDROCHLORIDE	TABLET;ORAL	50MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020281-001	ULTRAM	TRAMADOL HYDROCHLORIDE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-03-03
N020281-002	ULTRAM	TRAMADOL HYDROCHLORIDE	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-03-03

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 3 · 86 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
2026-09-14 22:38:34	2026-08	N020281-001	ULTRAM	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-03-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020281-002	ULTRAM	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-03-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020281-001	ULTRAM	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-03-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020281-002	ULTRAM	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-03-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020281-001	ULTRAM	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-03-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020281-002	ULTRAM	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-03-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020281-001	ULTRAM	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-03-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020281-002	ULTRAM	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-03-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020281-001	ULTRAM	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-03-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020281-002	ULTRAM	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-03-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020281-001	ULTRAM	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-03-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020281-002	ULTRAM	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-03-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020281-001	ULTRAM	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-03-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020281-002	ULTRAM	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-03-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020281-001	ULTRAM	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-03-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020281-002	ULTRAM	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-03-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020281-001	ULTRAM	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-03-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020281-002	ULTRAM	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-03-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020281-001	ULTRAM	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-03-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020281-002	ULTRAM	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-03-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020281-001	ULTRAM	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-03-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020281-002	ULTRAM	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-03-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020281-001	ULTRAM	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-03-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020281-002	ULTRAM	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-03-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020281-001	ULTRAM	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-03-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020281-002	ULTRAM	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-03-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020281-001	ULTRAM	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-03-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020281-002	ULTRAM	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-03-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020281-001	ULTRAM	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-03-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020281-002	ULTRAM	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-03-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020281-001	ULTRAM	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-03-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020281-002	ULTRAM	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-03-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020281-001	ULTRAM	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL			1995-03-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020281-002	ULTRAM	50MG	TABLET / ORAL	AB	RLD, RS	1995-03-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020281-001	ULTRAM	100MG	TABLET / ORAL			1995-03-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020281-002	ULTRAM	50MG	TABLET / ORAL	AB	RLD, RS	1995-03-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020281-001	ULTRAM	100MG	TABLET / ORAL			1995-03-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020281-002	ULTRAM	50MG	TABLET / ORAL	AB	RLD, RS	1995-03-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020281-001	ULTRAM	100MG	TABLET / ORAL			1995-03-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020281-002	ULTRAM	50MG	TABLET / ORAL	AB	RLD, RS	1995-03-03	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020281-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020281-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020281-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020281-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020281-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020281-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020281-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020281-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020281-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020281-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020281-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020281-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020281-002	AB	1	`ea99ee380514…`
2022-09-29 23:25 UTC	2022-09	N020281-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020281-002	AB	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N020281-001	6339105	2019-10-12	U-435		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020281-001	6339105*PED	2020-04-12		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020281-002	6339105	2019-10-12	U-435		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020281-002	6339105*PED	2020-04-12		Pediatric extension	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N020281-001	6339105*PED	2020-04-12		Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020281-002	6339105*PED	2020-04-12		Pediatric extension	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020281-001	6339105*PED	2020-04-12		Pediatric extension	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020281-002	6339105*PED	2020-04-12		Pediatric extension	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020281-001	6339105	2019-10-12	U-435		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020281-001	6339105*PED	2020-04-12		Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020281-002	6339105	2019-10-12	U-435		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020281-002	6339105*PED	2020-04-12		Pediatric extension	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020281-001	6339105	2019-10-12	U-435		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020281-001	6339105*PED	2020-04-12		Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020281-002	6339105	2019-10-12	U-435		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020281-002	6339105*PED	2020-04-12		Pediatric extension	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020281-001	6339105	2019-10-12	U-435		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020281-001	6339105*PED	2020-04-12		Pediatric extension	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020281-002	6339105	2019-10-12	U-435		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020281-002	6339105*PED	2020-04-12		Pediatric extension	`ea99ee380514…`

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 5 of 5 · 91 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Proficient Rx LP	0bff5535-0239-409e-8a2a-99d5ba38cca3	2022-11-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TRAMADOL HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Proficient Rx LP	00b7f61b-5173-43e6-a3f9-d2efbda40c19	2022-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TRAMADOL HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Asclemed USA, Inc.	dce0d21e-e4c2-4875-a2ce-9d53df190b80	2022-07-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TRAMADOL HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Proficient Rx LP	3c187736-ea96-4e59-9fe6-cb625a619c63	2022-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TRAMADOL HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Proficient Rx LP	27495d02-8641-4c92-b5a3-edf50abc2a6f	2022-05-02	Warnings, Adverse reactions	Name fallback generic name: TRAMADOL HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Proficient Rx LP	68646295-49b2-45ac-bf19-99bb91f7333d	2022-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TRAMADOL HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	Proficient Rx LP	f63facd7-519b-4e2b-b54f-c17fc9ede55f	2022-03-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TRAMADOL HYDROCHLORIDE
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Amneal Pharmaceuticals LLC	58b802cb-2443-4f5b-9718-7d54c6d50cb4	2021-10-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TRAMADOL HYDROCHLORIDE
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	TRUPHARMA LLC	61fb5ba7-6896-4ee4-83de-caee69b06a8e	2021-02-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TRAMADOL HYDROCHLORIDE
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Proficient Rx LP	50f4b752-20af-4ebf-9408-e78f30d2a3cc	2019-11-01	Warnings, Adverse reactions	Name fallback generic name: TRAMADOL HYDROCHLORIDE
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	bbd6c0d4-110c-4bda-9d9f-89ab7ce4c18e	2019-04-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TRAMADOL HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50458-659	ULTRAM	tramadol hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-659	ULTRAM	tramadol hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-659	ULTRAM	tramadol hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-659	ULTRAM	tramadol hydrochloride	Janssen Pharmaceuticals,	NDA	Current
50458-659	ULTRAM	tramadol hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-659	ULTRAM	tramadol hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-659	ULTRAM	tramadol hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76230	ORIG	2023-11-03
73501	SUPPL	2023-02-14
73500	SUPPL	2023-02-14
73491	SUPPL	2023-02-14
68609	SUPPL	2021-09-14
68608	SUPPL	2021-09-13
68607	SUPPL	2021-09-13
66585	SUPPL	2021-03-08
66584	SUPPL	2021-03-08
66506	SUPPL	2021-03-05
60342	SUPPL	2019-10-08
60327	SUPPL	2019-10-08
60326	SUPPL	2019-10-08
58278	SUPPL	2019-04-10
58263	SUPPL	2019-04-09
57644	ORIG	2019-02-15
55875	SUPPL	2018-10-11
55874	SUPPL	2018-10-11
55679	SUPPL	2018-10-01
55678	SUPPL	2018-10-01
49625	SUPPL	2017-08-30
49595	SUPPL	2017-08-30
46386	SUPPL	2016-12-21
46385	SUPPL	2016-12-21
46252	SUPPL	2016-12-20
46251	SUPPL	2016-12-20
24731	SUPPL	2009-11-12
24730	SUPPL	2009-11-12
34472	SUPPL	2009-10-06
12419	SUPPL	2009-10-06
24728	SUPPL	2004-06-29
24727	SUPPL	2004-06-29
34471	SUPPL	2004-05-03
2293	SUPPL	2004-04-20
20585	SUPPL	2003-08-07
20584	SUPPL	2003-08-07
34470	SUPPL	2003-04-22
34469	SUPPL	1999-12-23
24729	SUPPL	1999-12-23