Application 021611

Type: NDA
Sponsor: ENDO PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OPANA	OXYMORPHONE HYDROCHLORIDE	TABLET;ORAL	5MG	Yes	No
002	OPANA	OXYMORPHONE HYDROCHLORIDE	TABLET;ORAL	10MG	Yes	No

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

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
N021611-001	OPANA	OXYMORPHONE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-06-22
N021611-002	OPANA	OXYMORPHONE HYDROCHLORIDE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-06-22

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 · 82 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2026-02-19 14:30 UTC	2026-02	N021611-001	OPANA	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-06-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021611-002	OPANA	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-06-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021611-001	OPANA	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-06-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021611-002	OPANA	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-06-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021611-001	OPANA	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-06-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021611-002	OPANA	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-06-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021611-001	OPANA	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-06-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021611-002	OPANA	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-06-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021611-001	OPANA	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-06-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021611-002	OPANA	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-06-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021611-001	OPANA	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-06-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021611-002	OPANA	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-06-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021611-001	OPANA	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-06-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021611-002	OPANA	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-06-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021611-001	OPANA	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-06-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021611-002	OPANA	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-06-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021611-001	OPANA	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-06-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021611-002	OPANA	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-06-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021611-001	OPANA	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-06-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021611-002	OPANA	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-06-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021611-001	OPANA	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-06-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021611-002	OPANA	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-06-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021611-001	OPANA	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-06-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021611-002	OPANA	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-06-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021611-001	OPANA	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-06-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021611-002	OPANA	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-06-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021611-001	OPANA	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-06-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021611-002	OPANA	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-06-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021611-001	OPANA	5MG	TABLET / ORAL		RLD	2006-06-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021611-002	OPANA	10MG	TABLET / ORAL		RLD	2006-06-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021611-001	OPANA	5MG	TABLET / ORAL		RLD	2006-06-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021611-002	OPANA	10MG	TABLET / ORAL		RLD	2006-06-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021611-001	OPANA	5MG	TABLET / ORAL		RLD	2006-06-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021611-002	OPANA	10MG	TABLET / ORAL		RLD	2006-06-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021611-001	OPANA	5MG	TABLET / ORAL	AB	RLD	2006-06-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021611-002	OPANA	10MG	TABLET / ORAL	AB	RLD, RS	2006-06-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021611-001	OPANA	5MG	TABLET / ORAL		RLD	2006-06-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021611-002	OPANA	10MG	TABLET / ORAL		RLD	2006-06-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021611-001	OPANA	5MG	TABLET / ORAL		RLD	2006-06-22	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021611-002	OPANA	10MG	TABLET / ORAL		RLD	2006-06-22	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021611-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021611-002	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N021611-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021611-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021611-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021611-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021611-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021611-002	AB	1	`ea99ee380514…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021611-001	M-14	2022-10-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021611-002	M-14	2022-10-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021611-001	M-14	2022-10-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021611-002	M-14	2022-10-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021611-001	M-14	2022-10-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021611-002	M-14	2022-10-25	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N021611-001	M-14	2022-10-25	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021611-002	M-14	2022-10-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021611-001	M-14	2022-10-25	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021611-002	M-14	2022-10-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021611-001	M-14	2022-10-25	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021611-002	M-14	2022-10-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021611-001	M-14	2022-10-25	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021611-002	M-14	2022-10-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021611-001	M-14	2022-10-25	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021611-002	M-14	2022-10-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021611-001	M-14	2022-10-25	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021611-002	M-14	2022-10-25	`c0c555d07b60…`
2023-01-26 05:58 UTC	2023-01	N021611-001	M-14	2022-10-25	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N021611-002	M-14	2022-10-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021611-001	M-14	2022-10-25	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021611-002	M-14	2022-10-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021611-001	M-14	2022-10-25	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N021611-002	M-14	2022-10-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021611-001	M-14	2022-10-25	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N021611-002	M-14	2022-10-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021611-001	M-14	2022-10-25	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021611-002	M-14	2022-10-25	`cb3db0bc1861…`

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxymorphone Hydrochloride	OXYMORPHONE HYDROCHLORIDE	Aurolife Pharma, LLC	22c7652a-aa16-4fa8-89d9-517e69059068	2026-06-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OXYMORPHONE HYDROCHLORIDE
Oxymorphone Hydrochloride	OXYMORPHONE HYDROCHLORIDE	KVK-Tech, Inc.	dcb5b5d2-7d0a-497a-8f1e-3b96fd43320b	2026-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OXYMORPHONE HYDROCHLORIDE
Oxymorphone hydrochloride	OXYMORPHONE HYDROCHLORIDE	Amneal Pharmaceuticals LLC	3f4e703a-e398-42fd-8759-e398c79955f1	2026-01-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OXYMORPHONE HYDROCHLORIDE
Oxymorphone Hydrochloride	OXYMORPHONE HYDROCHLORIDE	Epic Pharma, LLC	95804e72-232d-425d-b23d-a66f43bdf0c6	2025-12-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OXYMORPHONE HYDROCHLORIDE
Oxymorphone Hydrochloride	OXYMORPHONE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	3eb971cf-ab82-49f3-a46c-4d76a8ce599e	2025-12-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OXYMORPHONE HYDROCHLORIDE
OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE	Camber Pharmaceuticals, Inc	06af7dff-c261-4c03-9cd9-0605c42507fa	2025-08-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OXYMORPHONE HYDROCHLORIDE
Oxymorphone hydrochloride	OXYMORPHONE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	557e9610-62d7-42bf-90c1-44215bd8c1f8	2024-01-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OXYMORPHONE HYDROCHLORIDE
OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE	Bryant Ranch Prepack	560e9425-dfcb-4fb4-a759-b1e3f8f40fdb	2024-01-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OXYMORPHONE HYDROCHLORIDE
OXYMORPHONE HYDROCHLORIDE	OXYMORPHONE HYDROCHLORIDE	XLCare Pharmaceuticals, Inc.	1a1d5061-b62a-49fa-a5b2-4970f51416ae	2020-05-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OXYMORPHONE HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
60951-794	Oxymorphone Hydrochloride	Oxymorphone Hydrochloride	Par Pharmaceutical	NDA AUTHORIZED GENERIC	Current
60951-794	Oxymorphone Hydrochloride	Oxymorphone Hydrochloride	Par Pharmaceutical	NDA AUTHORIZED GENERIC	Current
60951-795	Oxymorphone Hydrochloride	Oxymorphone Hydrochloride	Par Pharmaceutical	NDA AUTHORIZED GENERIC	Current
60951-795	Oxymorphone Hydrochloride	Oxymorphone Hydrochloride	Par Pharmaceutical	NDA AUTHORIZED GENERIC	Current
63481-612	OPANA	Oxymorphone Hydrochloride	Endo Pharmaceuticals, Inc.	NDA	Current
63481-612	OPANA	Oxymorphone Hydrochloride	Endo Pharmaceuticals Inc.	NDA	Current
63481-612	OPANA	Oxymorphone Hydrochloride	Endo Pharmaceuticals Inc.	NDA	Current
63481-612	OPANA	Oxymorphone Hydrochloride	Endo Pharmaceuticals, Inc.	NDA	Current
63481-613	OPANA	Oxymorphone Hydrochloride	Endo Pharmaceuticals, Inc.	NDA	Current
63481-613	OPANA	Oxymorphone Hydrochloride	Endo Pharmaceuticals Inc.	NDA	Current
63481-613	OPANA	Oxymorphone Hydrochloride	Endo Pharmaceuticals Inc.	NDA	Current
63481-613	OPANA	Oxymorphone Hydrochloride	Endo Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76234	ORIG	2023-11-03
60693	SUPPL	2019-10-29
60685	SUPPL	2019-10-28
60684	SUPPL	2019-10-28
60361	SUPPL	2019-10-08
60358	SUPPL	2019-10-08
55991	SUPPL	2018-10-17
55990	SUPPL	2018-10-17
55683	SUPPL	2018-10-01
55682	SUPPL	2018-10-01
46353	SUPPL	2016-12-21
46287	SUPPL	2016-12-20
15873	SUPPL	2014-05-14
5852	SUPPL	2012-07-11
5851	SUPPL	2011-02-10
37337	SUPPL	2011-02-09
5850	SUPPL	2010-04-22
42232	ORIG	2008-10-03
28244	SUPPL	2006-08-07
37336	SUPPL	2006-08-04
15872	ORIG	2006-06-28
5849	ORIG	2006-06-28
63214	SUPPL	1900-01-01
63213	SUPPL	1900-01-01