Application 021610

Type: NDA
Sponsor: ENDO PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OPANA ER	OXYMORPHONE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No
002	OPANA ER	OXYMORPHONE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No
003	OPANA ER	OXYMORPHONE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No
004	OPANA ER	OXYMORPHONE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	40MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No
005	OPANA ER	OXYMORPHONE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No
006	OPANA ER	OXYMORPHONE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	15MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No
007	OPANA ER	OXYMORPHONE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	30MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N021610-001	OPANA ER	OXYMORPHONE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-06-22
N021610-002	OPANA ER	OXYMORPHONE HYDROCHLORIDE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-06-22
N021610-003	OPANA ER	OXYMORPHONE HYDROCHLORIDE	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-06-22
N021610-004	OPANA ER	OXYMORPHONE HYDROCHLORIDE	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-06-22
N021610-005	OPANA ER	OXYMORPHONE HYDROCHLORIDE	7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-02-29
N021610-006	OPANA ER	OXYMORPHONE HYDROCHLORIDE	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-02-29
N021610-007	OPANA ER	OXYMORPHONE HYDROCHLORIDE	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-02-29

Orange Book patents#

Current patent rows page 1 of 1 · 14 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N021610-001	8808737	2027-06-21	U-3085		2021-03-18
N021610-001	8871779	2029-11-22		Drug substance	2021-03-18
N021610-002	8808737	2027-06-21	U-3085		2021-03-18
N021610-002	8871779	2029-11-22		Drug substance	2021-03-18
N021610-003	8808737	2027-06-21	U-3085		2021-03-18
N021610-003	8871779	2029-11-22		Drug substance	2021-03-18
N021610-004	8808737	2027-06-21	U-3085		2021-03-18
N021610-004	8871779	2029-11-22		Drug substance	2021-03-18
N021610-005	8808737	2027-06-21	U-3085		2021-03-18
N021610-005	8871779	2029-11-22		Drug substance	2021-03-18
N021610-006	8808737	2027-06-21	U-3085		2021-03-18
N021610-006	8871779	2029-11-22		Drug substance	2021-03-18
N021610-007	8808737	2027-06-21	U-3085		2021-03-18
N021610-007	8871779	2029-11-22		Drug substance	2021-03-18

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 8 · 287 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	N021610-001	OPANA ER	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-06-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021610-002	OPANA ER	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-06-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021610-003	OPANA ER	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-06-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021610-004	OPANA ER	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-06-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021610-005	OPANA ER	7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-02-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021610-006	OPANA ER	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-02-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021610-007	OPANA ER	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-02-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021610-001	OPANA ER	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-06-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021610-002	OPANA ER	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-06-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021610-003	OPANA ER	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-06-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021610-004	OPANA ER	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-06-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021610-005	OPANA ER	7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-02-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021610-006	OPANA ER	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-02-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021610-007	OPANA ER	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-02-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021610-001	OPANA ER	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-06-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021610-002	OPANA ER	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-06-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021610-003	OPANA ER	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-06-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021610-004	OPANA ER	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-06-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021610-005	OPANA ER	7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-02-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021610-006	OPANA ER	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-02-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021610-007	OPANA ER	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-02-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021610-001	OPANA ER	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-06-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021610-002	OPANA ER	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-06-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021610-003	OPANA ER	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-06-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021610-004	OPANA ER	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-06-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021610-005	OPANA ER	7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-02-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021610-006	OPANA ER	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-02-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021610-007	OPANA ER	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-02-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021610-001	OPANA ER	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-06-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021610-002	OPANA ER	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-06-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021610-003	OPANA ER	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-06-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021610-004	OPANA ER	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-06-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021610-005	OPANA ER	7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-02-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021610-006	OPANA ER	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-02-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021610-007	OPANA ER	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-02-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021610-001	OPANA ER	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-06-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021610-002	OPANA ER	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-06-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021610-003	OPANA ER	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-06-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021610-004	OPANA ER	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2006-06-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021610-005	OPANA ER	7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-02-29	`03ed91905a0d…`

Observed Orange Book patent history#

Patent history page 1 of 23 · 882 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	N021610-001	8808737	2027-06-21	U-3085		2021-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021610-001	8871779	2029-11-22		Drug substance	2021-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021610-002	8808737	2027-06-21	U-3085		2021-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021610-002	8871779	2029-11-22		Drug substance	2021-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021610-003	8808737	2027-06-21	U-3085		2021-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021610-003	8871779	2029-11-22		Drug substance	2021-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021610-004	8808737	2027-06-21	U-3085		2021-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021610-004	8871779	2029-11-22		Drug substance	2021-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021610-005	8808737	2027-06-21	U-3085		2021-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021610-005	8871779	2029-11-22		Drug substance	2021-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021610-006	8808737	2027-06-21	U-3085		2021-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021610-006	8871779	2029-11-22		Drug substance	2021-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021610-007	8808737	2027-06-21	U-3085		2021-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021610-007	8871779	2029-11-22		Drug substance	2021-03-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021610-001	8808737	2027-06-21	U-3085		2021-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021610-001	8871779	2029-11-22		Drug substance	2021-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021610-002	8808737	2027-06-21	U-3085		2021-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021610-002	8871779	2029-11-22		Drug substance	2021-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021610-003	8808737	2027-06-21	U-3085		2021-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021610-003	8871779	2029-11-22		Drug substance	2021-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021610-004	8808737	2027-06-21	U-3085		2021-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021610-004	8871779	2029-11-22		Drug substance	2021-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021610-005	8808737	2027-06-21	U-3085		2021-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021610-005	8871779	2029-11-22		Drug substance	2021-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021610-006	8808737	2027-06-21	U-3085		2021-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021610-006	8871779	2029-11-22		Drug substance	2021-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021610-007	8808737	2027-06-21	U-3085		2021-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021610-007	8871779	2029-11-22		Drug substance	2021-03-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021610-001	8808737	2027-06-21	U-3085		2021-03-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021610-001	8871779	2029-11-22		Drug substance	2021-03-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021610-002	8808737	2027-06-21	U-3085		2021-03-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021610-002	8871779	2029-11-22		Drug substance	2021-03-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021610-003	8808737	2027-06-21	U-3085		2021-03-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021610-003	8871779	2029-11-22		Drug substance	2021-03-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021610-004	8808737	2027-06-21	U-3085		2021-03-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021610-004	8871779	2029-11-22		Drug substance	2021-03-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021610-005	8808737	2027-06-21	U-3085		2021-03-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021610-005	8871779	2029-11-22		Drug substance	2021-03-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021610-006	8808737	2027-06-21	U-3085		2021-03-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021610-006	8871779	2029-11-22		Drug substance	2021-03-18	`6a471c1ec25d…`

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
21695-948	OPANA ER	Oxymorphone Hydrochloride	Rebel Distributors Corp	NDA	Current
21695-949	OPANA ER	Oxymorphone Hydrochloride	Rebel Distributors Corp	NDA	Current
63629-4174	Opana ER	OXYMORPHONE HYDROCHLORIDE	Bryant Ranch Prepack	NDA	Current
63629-4177	OPANA	Oxymorphone Hydrochloride	Bryant Ranch Prepack	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80070	SUPPL	2024-11-04
77003	SUPPL	2023-12-19
76909	SUPPL	2023-12-18
76908	SUPPL	2023-12-18
70881	SUPPL	2022-05-02
70850	SUPPL	2022-04-29
70849	SUPPL	2022-04-29
66623	SUPPL	2021-03-08
66622	SUPPL	2021-03-08
66552	SUPPL	2021-03-05
60359	SUPPL	2019-10-08
60352	SUPPL	2019-10-08
60351	SUPPL	2019-10-08
55987	SUPPL	2018-10-17
55986	SUPPL	2018-10-17
55734	SUPPL	2018-10-01
55733	SUPPL	2018-10-01
48565	SUPPL	2017-05-30
46354	SUPPL	2016-12-21
46284	SUPPL	2016-12-20
45465	SUPPL	2016-10-04
28243	SUPPL	2016-04-22
5848	SUPPL	2015-07-06
5847	SUPPL	2014-08-20
5846	SUPPL	2014-04-17
37335	SUPPL	2014-04-16
44481	ORIG	2013-05-31
28242	SUPPL	2013-04-18
28241	SUPPL	2012-07-13
15871	SUPPL	2012-07-13
15870	SUPPL	2012-07-12
5845	SUPPL	2012-07-11
28240	SUPPL	2010-10-12
37334	SUPPL	2010-10-04
15869	SUPPL	2008-03-05
5844	SUPPL	2008-03-05
15868	SUPPL	2008-01-18
5843	SUPPL	2008-01-18
28239	SUPPL	2007-07-16
15867	SUPPL	2007-07-10
5842	SUPPL	2006-08-07
15866	SUPPL	2006-08-04