Roxybond

Product NDC: 65597-503
11-digit product format: 655970503
Labeler code: 65597
Product ID: 65597-503_eb44aa7a-4db6-42ab-9141-8dbf3742be60
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: oxycodone hydrochloride
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Daiichi Sankyo Inc.
Application: NDA209777
Marketing category: NDA
Marketing start: 2017-04-20
Marketing end: 0000-00-00
Substance: OXYCODONE HYDROCHLORIDE
Active strength: 30 mg/1
Pharmacologic classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2020-12-31
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	65597-503		D	Discontinued by firm		2026-10-05
excluded package	package	65597-503	65597-503-10	D	Discontinued by firm		2026-10-05

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 · 24 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	65597-503-10	`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	65597-503-10	`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	65597-503-10	`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	65597-503-10	`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	65597-503-10	`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	65597-503-10	`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	65597-503-10	`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	65597-503-10	`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	65597-503-10	`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	65597-503-10	`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	65597-503-10	`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	65597-503-10	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
N209777-001	ROXYBOND	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	2017-04-20
N209777-002	ROXYBOND	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	2017-04-20
N209777-003	ROXYBOND	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	2017-04-20
N209777-004	ROXYBOND	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	2024-09-05

Orange Book patents#

Current patent rows page 1 of 1 · 8 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N209777-001	10314788	2028-08-12	Drug product	2019-07-10
N209777-001	7955619	2028-08-12	Drug product	2017-05-19
N209777-002	10314788	2028-08-12	Drug product	2019-07-10
N209777-002	7955619	2028-08-12	Drug product	2017-05-19
N209777-003	10314788	2028-08-12	Drug product	2019-07-10
N209777-003	7955619	2028-08-12	Drug product	2017-05-19
N209777-004	10314788	2028-08-12	Drug product	2024-10-04
N209777-004	7955619	2028-08-12	Drug product	2024-10-04

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 · 141 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N209777-001	ROXYBOND	5MG	TABLET / ORAL	2017-04-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209777-002	ROXYBOND	15MG	TABLET / ORAL	2017-04-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209777-003	ROXYBOND	30MG	TABLET / ORAL	2017-04-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209777-004	ROXYBOND	10MG	TABLET / ORAL	2024-09-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209777-001	ROXYBOND	5MG	TABLET / ORAL	2017-04-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209777-002	ROXYBOND	15MG	TABLET / ORAL	2017-04-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209777-003	ROXYBOND	30MG	TABLET / ORAL	2017-04-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209777-004	ROXYBOND	10MG	TABLET / ORAL	2024-09-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209777-001	ROXYBOND	5MG	TABLET / ORAL	2017-04-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209777-002	ROXYBOND	15MG	TABLET / ORAL	2017-04-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209777-003	ROXYBOND	30MG	TABLET / ORAL	2017-04-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209777-004	ROXYBOND	10MG	TABLET / ORAL	2024-09-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209777-001	ROXYBOND	5MG	TABLET / ORAL	2017-04-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209777-002	ROXYBOND	15MG	TABLET / ORAL	2017-04-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209777-003	ROXYBOND	30MG	TABLET / ORAL	2017-04-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209777-004	ROXYBOND	10MG	TABLET / ORAL	2024-09-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209777-001	ROXYBOND	5MG	TABLET / ORAL	2017-04-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209777-002	ROXYBOND	15MG	TABLET / ORAL	2017-04-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209777-003	ROXYBOND	30MG	TABLET / ORAL	2017-04-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209777-004	ROXYBOND	10MG	TABLET / ORAL	2024-09-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209777-001	ROXYBOND	5MG	TABLET / ORAL	2017-04-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209777-002	ROXYBOND	15MG	TABLET / ORAL	2017-04-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209777-003	ROXYBOND	30MG	TABLET / ORAL	2017-04-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209777-004	ROXYBOND	10MG	TABLET / ORAL	2024-09-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209777-001	ROXYBOND	5MG	TABLET / ORAL	2017-04-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209777-002	ROXYBOND	15MG	TABLET / ORAL	2017-04-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209777-003	ROXYBOND	30MG	TABLET / ORAL	2017-04-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209777-004	ROXYBOND	10MG	TABLET / ORAL	2024-09-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209777-001	ROXYBOND	5MG	TABLET / ORAL	2017-04-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209777-002	ROXYBOND	15MG	TABLET / ORAL	2017-04-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209777-003	ROXYBOND	30MG	TABLET / ORAL	2017-04-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209777-004	ROXYBOND	10MG	TABLET / ORAL	2024-09-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209777-001	ROXYBOND	5MG	TABLET / ORAL	2017-04-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209777-002	ROXYBOND	15MG	TABLET / ORAL	2017-04-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209777-003	ROXYBOND	30MG	TABLET / ORAL	2017-04-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209777-004	ROXYBOND	10MG	TABLET / ORAL	2024-09-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209777-001	ROXYBOND	5MG	TABLET / ORAL	2017-04-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209777-002	ROXYBOND	15MG	TABLET / ORAL	2017-04-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209777-003	ROXYBOND	30MG	TABLET / ORAL	2017-04-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209777-001	ROXYBOND	5MG	TABLET / ORAL	2017-04-20	`d8e5a09893c0…`

Observed Orange Book patent history#

Patent history page 1 of 8 · 282 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N209777-001	10314788	2028-08-12	Drug product	2019-07-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209777-001	7955619	2028-08-12	Drug product	2017-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209777-002	10314788	2028-08-12	Drug product	2019-07-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209777-002	7955619	2028-08-12	Drug product	2017-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209777-003	10314788	2028-08-12	Drug product	2019-07-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209777-003	7955619	2028-08-12	Drug product	2017-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209777-004	10314788	2028-08-12	Drug product	2024-10-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209777-004	7955619	2028-08-12	Drug product	2024-10-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209777-001	10314788	2028-08-12	Drug product	2019-07-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209777-001	7955619	2028-08-12	Drug product	2017-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209777-002	10314788	2028-08-12	Drug product	2019-07-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209777-002	7955619	2028-08-12	Drug product	2017-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209777-003	10314788	2028-08-12	Drug product	2019-07-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209777-003	7955619	2028-08-12	Drug product	2017-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209777-004	10314788	2028-08-12	Drug product	2024-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209777-004	7955619	2028-08-12	Drug product	2024-10-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209777-001	10314788	2028-08-12	Drug product	2019-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209777-001	7955619	2028-08-12	Drug product	2017-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209777-002	10314788	2028-08-12	Drug product	2019-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209777-002	7955619	2028-08-12	Drug product	2017-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209777-003	10314788	2028-08-12	Drug product	2019-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209777-003	7955619	2028-08-12	Drug product	2017-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209777-004	10314788	2028-08-12	Drug product	2024-10-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209777-004	7955619	2028-08-12	Drug product	2024-10-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209777-001	10314788	2028-08-12	Drug product	2019-07-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209777-001	7955619	2028-08-12	Drug product	2017-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209777-002	10314788	2028-08-12	Drug product	2019-07-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209777-002	7955619	2028-08-12	Drug product	2017-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209777-003	10314788	2028-08-12	Drug product	2019-07-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209777-003	7955619	2028-08-12	Drug product	2017-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209777-004	10314788	2028-08-12	Drug product	2024-10-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209777-004	7955619	2028-08-12	Drug product	2024-10-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209777-001	10314788	2028-08-12	Drug product	2019-07-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209777-001	7955619	2028-08-12	Drug product	2017-05-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209777-002	10314788	2028-08-12	Drug product	2019-07-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209777-002	7955619	2028-08-12	Drug product	2017-05-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209777-003	10314788	2028-08-12	Drug product	2019-07-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209777-003	7955619	2028-08-12	Drug product	2017-05-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209777-004	10314788	2028-08-12	Drug product	2024-10-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209777-004	7955619	2028-08-12	Drug product	2024-10-04	`6a471c1ec25d…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N209777-001	NP	2020-04-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209777-002	NP	2020-04-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209777-003	NP	2020-04-20	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N209777-001	NP	2020-04-20	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N209777-002	NP	2020-04-20	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N209777-003	NP	2020-04-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209777-001	NP	2020-04-20	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N209777-002	NP	2020-04-20	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N209777-003	NP	2020-04-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209777-001	NP	2020-04-20	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N209777-002	NP	2020-04-20	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N209777-003	NP	2020-04-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209777-001	NP	2020-04-20	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N209777-002	NP	2020-04-20	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N209777-003	NP	2020-04-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209777-001	NP	2020-04-20	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N209777-002	NP	2020-04-20	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N209777-003	NP	2020-04-20	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65597-503-10	EA - Each	65597-503	cc73981e-586f-43ee-84c8-02b7c81c2eb7	1	2018-07-03

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
RoxyBond	OXYCODONE HYDROCHLORIDE	Protega Pharmaceuticals Inc	72398542-8e0a-47b2-afeb-9ca5a1f15083	2026-01-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 209777 application number: NDA209777