OPANA

Product NDC: 63629-4177
11-digit product format: 636294177
Labeler code: 63629
Product ID: 63629-4177_b8bdd68c-ac5d-4244-b9d9-1818cafa9674
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oxymorphone Hydrochloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: NDA021610
Marketing category: NDA
Marketing start: 2006-06-30
Marketing end: 0000-00-00
Substance: OXYMORPHONE HYDROCHLORIDE
Active strength: 40 mg/1
Pharmacologic classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC]
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	63629-4177		D	Discontinued by firm	2026-08-11
excluded package	package	63629-4177	63629-4177-1	D	Discontinued by firm	2026-08-11
excluded package	package	63629-4177	63629-4177-2	D	Discontinued by firm	2026-08-11
excluded package	package	63629-4177	63629-4177-3	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 · 60 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-4177-3	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-4177-1	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-4177-2	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-4177-3	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-4177-1	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-4177-2	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-4177-3	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-4177-1	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-4177-2	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-4177-3	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-4177-1	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-4177-2	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-4177-3	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-4177-1	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-4177-2	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-4177-3	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-4177-1	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-4177-2	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-4177-3	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-4177-1	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-4177-2	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-4177-3	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-4177-1	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-4177-2	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-4177-3	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-4177-1	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-4177-2	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63629-4177-3	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63629-4177-1	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63629-4177-2	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63629-4177-3	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63629-4177-1	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63629-4177-2	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63629-4177-3	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63629-4177-1	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63629-4177-2	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	63629-4177-2	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	63629-4177-1	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	63629-4177-3	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	63629-4177-2	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	63629-4177-1	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	63629-4177-3	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		I	Inactivated by FDA	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	63629-4177-2	I	Inactivated by FDA	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	63629-4177-1	I	Inactivated by FDA	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	63629-4177-3	I	Inactivated by FDA	`110d247fa046…`	`a55b01930146…`

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…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63629-4177-1	2021-11-17	These highlights do not include all the information needed to use OPANA ER safely and effectively. See full prescribing information for OPANA ER. OPANA ER (Oxymorphone Hydrochloride) Extended-Release Tablets, CII Initial U.S. Approval: 2009 ® ® ®
63629-4177-2	2021-11-17	These highlights do not include all the information needed to use OPANA ER safely and effectively. See full prescribing information for OPANA ER. OPANA ER (Oxymorphone Hydrochloride) Extended-Release Tablets, CII Initial U.S. Approval: 2009 ® ® ®
63629-4177-3	2021-11-17	These highlights do not include all the information needed to use OPANA ER safely and effectively. See full prescribing information for OPANA ER. OPANA ER (Oxymorphone Hydrochloride) Extended-Release Tablets, CII Initial U.S. Approval: 2009 ® ® ®
63629-4177-1	2019-11-27	These highlights do not include all the information needed to use OPANA ER safely and effectively. See full prescribing information for OPANA ER. OPANA ER (Oxymorphone Hydrochloride) Extended-Release Tablets, CII Initial U.S. Approval: 2009 ® ® ®
63629-4177-2	2019-11-27	These highlights do not include all the information needed to use OPANA ER safely and effectively. See full prescribing information for OPANA ER. OPANA ER (Oxymorphone Hydrochloride) Extended-Release Tablets, CII Initial U.S. Approval: 2009 ® ® ®
63629-4177-3	2019-11-27	These highlights do not include all the information needed to use OPANA ER safely and effectively. See full prescribing information for OPANA ER. OPANA ER (Oxymorphone Hydrochloride) Extended-Release Tablets, CII Initial U.S. Approval: 2009 ® ® ®

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OXYMORPHONE HYDROCHLORIDE	ACTIVE INGREDIENT	5Y2EI94NBC	OPANA ER (OXYMORPHONE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]	2
OXYMORPHONE	ACTIVE MOIETY	9VXA968E0C	OPANA ER (OXYMORPHONE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	OPANA ER (OXYMORPHONE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	OPANA ER (OXYMORPHONE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	OPANA ER (OXYMORPHONE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	OPANA ER (OXYMORPHONE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	OPANA ER (OXYMORPHONE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]	2
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	OPANA ER (OXYMORPHONE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OPANA ER (OXYMORPHONE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]	2
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	OPANA ER (OXYMORPHONE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]	2