OXYCODONE HYDROCHLORIDE

Product NDC: 67296-1376
11-digit product format: 672961376
Labeler code: 67296
Product ID: 67296-1376_d61fb856-cf5a-4500-e053-2995a90ad417
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: OXYCODONE HYDROCHLORIDE
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: RedPharm Drug, Inc.
Application: NDA022272
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2016-02-22
Marketing end: 0000-00-00
Substance: OXYCODONE HYDROCHLORIDE
Active strength: 10 mg/1
Pharmacologic classes: Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2023-12-31
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	67296-1376		I	Inactivated by FDA		2026-10-05
excluded package	package	67296-1376	67296-1376-2	I	Inactivated by FDA		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 · 32 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		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67296-1376-2	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67296-1376-2	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67296-1376-2	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67296-1376-2	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67296-1376-2	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67296-1376-2	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67296-1376-2	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67296-1376-2	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67296-1376-2	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	67296-1376-2	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	67296-1376-2	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67296-1376-2	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	67296-1376-2	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	67296-1376-2	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67296-1376-2	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	67296-1376-2	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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

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
N022272-001	OXYCONTIN	OXYCODONE HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-04-05
N022272-002	OXYCONTIN	OXYCODONE HYDROCHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-04-05
N022272-003	OXYCONTIN	OXYCODONE HYDROCHLORIDE	20MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-04-05
N022272-004	OXYCONTIN	OXYCODONE HYDROCHLORIDE	30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-04-05
N022272-005	OXYCONTIN	OXYCODONE HYDROCHLORIDE	40MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2010-04-05
N022272-006	OXYCONTIN	OXYCODONE HYDROCHLORIDE	60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-04-05
N022272-007	OXYCONTIN	OXYCODONE HYDROCHLORIDE	80MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-04-05

Orange Book patents#

Current patent rows page 1 of 2 · 102 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022272-001	11304908	2027-08-24		Drug product	2022-04-21
N022272-001	11304909	2027-08-24	U-1556		2022-04-21
N022272-001	11964056	2027-08-24		Drug product	2024-04-25
N022272-001	12246094	2027-08-24		Drug product	2025-03-14
N022272-001	12280152	2027-08-24		Drug product	2025-05-22
N022272-001	8808741	2027-08-24	U-1556		2014-08-19
N022272-001	8894988	2027-08-24		Drug product	2014-11-25
N022272-001	9492389	2027-08-24		Drug product	2016-11-16
N022272-001	9492391	2027-08-24	U-1556		2016-11-16
N022272-001	9492392	2027-08-24		Drug product	2016-11-16
N022272-001	9492393	2027-08-24	U-1556		2016-11-16
N022272-001	9763933	2027-08-24		Drug product	2017-09-19
N022272-001	9770416	2027-08-24		Drug product	2017-09-27
N022272-001	9775808	2027-08-24		Drug product	2017-10-04
N022272-001	8894987	2030-03-29		Drug product	2014-11-25
N022272-002	11304908	2027-08-24		Drug product	2022-04-21
N022272-002	11304909	2027-08-24	U-1556		2022-04-21
N022272-002	11964056	2027-08-24		Drug product	2024-04-25
N022272-002	12246094	2027-08-24		Drug product	2025-03-14
N022272-002	12280152	2027-08-24		Drug product	2025-05-22
N022272-002	8808741	2027-08-24	U-1556		2014-08-19
N022272-002	8894988	2027-08-24		Drug product	2014-11-25
N022272-002	9492389	2027-08-24		Drug product	2016-11-16
N022272-002	9492391	2027-08-24	U-1556		2016-11-16
N022272-002	9492392	2027-08-24		Drug product	2016-11-16
N022272-002	9492393	2027-08-24	U-1556		2016-11-16
N022272-002	9763933	2027-08-24		Drug product	2017-09-19
N022272-002	9770416	2027-08-24		Drug product	2017-09-27
N022272-002	9775808	2027-08-24		Drug product	2017-10-04
N022272-002	8894987	2030-03-29		Drug product	2014-11-25
N022272-003	11304908	2027-08-24		Drug product	2022-04-21
N022272-003	11304909	2027-08-24	U-1556		2022-04-21
N022272-003	11964056	2027-08-24		Drug product	2024-04-25
N022272-003	12246094	2027-08-24		Drug product	2025-03-14
N022272-003	12280152	2027-08-24		Drug product	2025-05-22
N022272-003	8808741	2027-08-24	U-1556		2014-08-19
N022272-003	8894988	2027-08-24		Drug product	2014-11-25
N022272-003	9492389	2027-08-24		Drug product	2016-11-16
N022272-003	9492391	2027-08-24	U-1556		2016-11-16
N022272-003	9492392	2027-08-24		Drug product	2016-11-16
N022272-003	9492393	2027-08-24	U-1556		2016-11-16
N022272-003	9763933	2027-08-24		Drug product	2017-09-19
N022272-003	9770416	2027-08-24		Drug product	2017-09-27
N022272-003	9775808	2027-08-24		Drug product	2017-10-04
N022272-003	8894987	2030-03-29		Drug product	2014-11-25
N022272-004	11304908	2027-08-24		Drug product	2022-04-21
N022272-004	11304909	2027-08-24	U-1556		2022-04-21
N022272-004	11964056	2027-08-24		Drug product	2024-04-25
N022272-004	12246094	2027-08-24		Drug product	2025-03-14
N022272-004	12280152	2027-08-24		Drug product	2025-05-22
N022272-004	8808741	2027-08-24	U-1556		2014-08-19
N022272-004	8894988	2027-08-24		Drug product	2014-11-25
N022272-004	9492389	2027-08-24		Drug product	2016-11-16
N022272-004	9492391	2027-08-24	U-1556		2016-11-16
N022272-004	9492392	2027-08-24		Drug product	2016-11-16
N022272-004	9492393	2027-08-24	U-1556		2016-11-16
N022272-004	9763933	2027-08-24		Drug product	2017-09-19
N022272-004	9770416	2027-08-24		Drug product	2017-09-27
N022272-004	9775808	2027-08-24		Drug product	2017-10-04
N022272-004	8894987	2030-03-29		Drug product	2014-11-25
N022272-005	11304908	2027-08-24		Drug product	2022-04-21
N022272-005	11304909	2027-08-24	U-1556		2022-04-21
N022272-005	11964056	2027-08-24		Drug product	2024-04-25
N022272-005	12246094	2027-08-24		Drug product	2025-03-14
N022272-005	12280152	2027-08-24		Drug product	2025-05-22
N022272-005	8808741	2027-08-24	U-1556		2014-08-19
N022272-005	8894988	2027-08-24		Drug product	2014-11-25
N022272-005	9492389	2027-08-24		Drug product	2016-11-16
N022272-005	9492391	2027-08-24	U-1556		2016-11-16
N022272-005	9492392	2027-08-24		Drug product	2016-11-16
N022272-005	9492393	2027-08-24	U-1556		2016-11-16
N022272-005	9763933	2027-08-24		Drug product	2017-09-19
N022272-005	9770416	2027-08-24		Drug product	2017-09-27
N022272-005	9775808	2027-08-24		Drug product	2017-10-04
N022272-006	11304908	2027-08-24		Drug product	2022-04-21
N022272-006	11304909	2027-08-24	U-1556		2022-04-21
N022272-006	11964056	2027-08-24		Drug product	2024-04-25
N022272-006	12246094	2027-08-24		Drug product	2025-03-14
N022272-006	12280152	2027-08-24		Drug product	2025-05-22
N022272-006	8808741	2027-08-24	U-1556		2014-08-19

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 · 301 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N022272-001	OXYCONTIN	10MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-04-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022272-002	OXYCONTIN	15MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-04-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022272-003	OXYCONTIN	20MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-04-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022272-004	OXYCONTIN	30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-04-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022272-005	OXYCONTIN	40MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2010-04-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022272-006	OXYCONTIN	60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-04-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022272-007	OXYCONTIN	80MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-04-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022272-001	OXYCONTIN	10MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022272-002	OXYCONTIN	15MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022272-003	OXYCONTIN	20MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022272-004	OXYCONTIN	30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022272-005	OXYCONTIN	40MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2010-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022272-006	OXYCONTIN	60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-04-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022272-007	OXYCONTIN	80MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-04-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022272-001	OXYCONTIN	10MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022272-002	OXYCONTIN	15MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022272-003	OXYCONTIN	20MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022272-004	OXYCONTIN	30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022272-005	OXYCONTIN	40MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2010-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022272-006	OXYCONTIN	60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022272-007	OXYCONTIN	80MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-04-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022272-001	OXYCONTIN	10MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-04-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022272-002	OXYCONTIN	15MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-04-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022272-003	OXYCONTIN	20MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-04-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022272-004	OXYCONTIN	30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-04-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022272-005	OXYCONTIN	40MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2010-04-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022272-006	OXYCONTIN	60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-04-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022272-007	OXYCONTIN	80MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-04-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022272-001	OXYCONTIN	10MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-04-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022272-002	OXYCONTIN	15MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-04-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022272-003	OXYCONTIN	20MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-04-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022272-004	OXYCONTIN	30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-04-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022272-005	OXYCONTIN	40MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2010-04-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022272-006	OXYCONTIN	60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-04-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022272-007	OXYCONTIN	80MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-04-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022272-001	OXYCONTIN	10MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-04-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022272-002	OXYCONTIN	15MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-04-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022272-003	OXYCONTIN	20MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-04-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022272-004	OXYCONTIN	30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-04-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022272-005	OXYCONTIN	40MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2010-04-05	`fd3edfee7708…`

Observed Orange Book patent history#

Patent history page 1 of 139 · 5,544 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N022272-001	11304908	2027-08-24		Drug product	2022-04-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022272-001	11304909	2027-08-24	U-1556		2022-04-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022272-001	11964056	2027-08-24		Drug product	2024-04-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022272-001	12246094	2027-08-24		Drug product	2025-03-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022272-001	12280152	2027-08-24		Drug product	2025-05-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022272-001	8808741	2027-08-24	U-1556		2014-08-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022272-001	8894988	2027-08-24		Drug product	2014-11-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022272-001	9492389	2027-08-24		Drug product	2016-11-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022272-001	9492391	2027-08-24	U-1556		2016-11-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022272-001	9492392	2027-08-24		Drug product	2016-11-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022272-001	9492393	2027-08-24	U-1556		2016-11-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022272-001	9763933	2027-08-24		Drug product	2017-09-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022272-001	9770416	2027-08-24		Drug product	2017-09-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022272-001	9775808	2027-08-24		Drug product	2017-10-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022272-001	8894987	2030-03-29		Drug product	2014-11-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022272-002	11304908	2027-08-24		Drug product	2022-04-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022272-002	11304909	2027-08-24	U-1556		2022-04-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022272-002	11964056	2027-08-24		Drug product	2024-04-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022272-002	12246094	2027-08-24		Drug product	2025-03-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022272-002	12280152	2027-08-24		Drug product	2025-05-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022272-002	8808741	2027-08-24	U-1556		2014-08-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022272-002	8894988	2027-08-24		Drug product	2014-11-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022272-002	9492389	2027-08-24		Drug product	2016-11-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022272-002	9492391	2027-08-24	U-1556		2016-11-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022272-002	9492392	2027-08-24		Drug product	2016-11-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022272-002	9492393	2027-08-24	U-1556		2016-11-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022272-002	9763933	2027-08-24		Drug product	2017-09-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022272-002	9770416	2027-08-24		Drug product	2017-09-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022272-002	9775808	2027-08-24		Drug product	2017-10-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022272-002	8894987	2030-03-29		Drug product	2014-11-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022272-003	11304908	2027-08-24		Drug product	2022-04-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022272-003	11304909	2027-08-24	U-1556		2022-04-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022272-003	11964056	2027-08-24		Drug product	2024-04-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022272-003	12246094	2027-08-24		Drug product	2025-03-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022272-003	12280152	2027-08-24		Drug product	2025-05-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022272-003	8808741	2027-08-24	U-1556		2014-08-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022272-003	8894988	2027-08-24		Drug product	2014-11-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022272-003	9492389	2027-08-24		Drug product	2016-11-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022272-003	9492391	2027-08-24	U-1556		2016-11-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022272-003	9492392	2027-08-24		Drug product	2016-11-16	`84e616aacf4f…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
92ead9ae-674d-4eee-a492-c385d496891f	Product name	3	20220308
b8cd3792-f010-440e-ac63-7713119fde04	Product name	9	20220110
bde672ba-4805-28d0-1986-73543d41b412	Product name	2	20210201
b8497372-efe9-9dde-fa2d-59be9761aa64	Product name	9	20200428
ac683e31-73f8-f1cd-ff51-87d7b0d20ab3	Product name	9	20190611
2a0c98e1-033f-4e0d-a0da-b5291ffbe880	Product name	1	20190320
b7a189a6-82e9-f884-a16b-8cdc7e7d1556	Product name	6	20170913
5da64f4c-1e90-423d-af7a-5a52bb3e823e	Product name	4	20170726
334cd9e0-ccc1-4fe7-b3a9-7d5942867ee6	Product name	1	20170628
8e48b6b8-3a2f-4e0d-b7c9-38d70393b778	Product name	1	20161103
68d3ff71-7803-4cf4-ba84-71ce4712df22	Product name	1	20160620
07e5b999-fda7-79c9-8f77-8380537ade79	Product name	4	20160517
8a245632-e24f-4ccc-b671-995d89c96ebc	Product name	1	20141203
23475c0b-a5b5-4fec-b97f-acca901eae6a	Product name	1	20140718
7b2938c9-7eb7-e312-ae90-f54f4240361e	Product name	1	20140508
7fa873c5-fb27-7119-0a05-634ad477dea7	Product name	1	20140508
c8753a88-edde-8e17-a396-705537b52cee	Product name	1	20140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ce	Product name	1	20140508
cf3a804d-0326-aa22-0142-c184b5657d85	Product name	1	20140508
f46484d2-0de6-24f4-bf73-a8f2af6723ef	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67296-1376-2	2024-01-30	C162847	48780-1	1030e365-54fc-111a-e063-dadaa90a10e2	504aa63a-4772-2e03-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67296-1376-2	OXYCODONE HYDROCHLORIDE	20 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	20		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67296-1376	OXYCODONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [REDPHARM DRUG, INC.]	5	Legacy NDC, 1 package rows	20220123_504aa63a-4772-2e03-e054-00144ff88e88.zip

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OxyContin	OXYCODONE HYDROCHLORIDE	Knoa Pharma LLC	bfdfe235-d717-4855-a3c8-a13d26dadede	2026-06-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022272 application number: NDA022272
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	c2c57ae7-86b9-47bb-a31b-ed1c4327ce7f	2026-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022272 application number: NDA022272

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
C1ENJ2TE6C	OXYCODONE HYDROCHLORIDE	124-90-3	OXYCODONE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1860157	oxyCODONE HCl 10 MG 12HR Extended Release Oral Tablet, Abuse-Deterrent	PSN	504aa63a-4772-2e03-e054-00144ff88e88	5
1860157	Abuse-Deterrent 12 HR oxycodone hydrochloride 10 MG Extended Release Oral Tablet	SCD	504aa63a-4772-2e03-e054-00144ff88e88	5
1860157	oxycodone HCl 10 MG 12 HR Extended Release Oral Tablet, Abuse-Deterrent	SY	504aa63a-4772-2e03-e054-00144ff88e88	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
67296-1376-2	67296137602	20 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67296-1376-2)	2016-02-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
OXYCODONE HYDROCHLORIDE - RedPharm Drug, Inc.	RedPharm Drug, Inc.	2022-01-21	HUMAN PRESCRIPTION DRUG LABEL	5