Oxycodone Hydrochloride

Product NDC: 68071-5055
11-digit product format: 680715055
Labeler code: 68071
Product ID: 68071-5055_bbb6750d-48e7-e94e-e053-2995a90aaf93
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oxycodone
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA203638
Marketing category: ANDA
Marketing start: 2012-10-30
Marketing end: 0000-00-00
Substance: OXYCODONE HYDROCHLORIDE
Active strength: 5 mg/1
Pharmacologic classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2022-12-31
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	68071-5055		D	Discontinued by firm		2026-08-11
excluded package	package	68071-5055	68071-5055-6	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 · 30 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	68071-5055-6	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	68071-5055-6	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	68071-5055-6	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	68071-5055-6	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	68071-5055-6	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	68071-5055-6	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	68071-5055-6	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	68071-5055-6	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	68071-5055-6	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	68071-5055-6	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	68071-5055-6	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	68071-5055-6	D	Discontinued by firm	`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	68071-5055-6	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	68071-5055-6	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	68071-5055-6	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A203638-001	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-06-03
A203638-002	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-06-03
A203638-003	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2014-06-03
A203638-004	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2014-06-03
A203638-005	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2014-06-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A203638-001	AB
A203638-002	AB
A203638-003	AB
A203638-004	AB
A203638-005	AB

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 6 · 205 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203638-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203638-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203638-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2014-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203638-004	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2014-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203638-005	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2014-06-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203638-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203638-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203638-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2014-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203638-004	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2014-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203638-005	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2014-06-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203638-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203638-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203638-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2014-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203638-004	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2014-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203638-005	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2014-06-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203638-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-06-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203638-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-06-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203638-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2014-06-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203638-004	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2014-06-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203638-005	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2014-06-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203638-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-06-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203638-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-06-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203638-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2014-06-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203638-004	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2014-06-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203638-005	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2014-06-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203638-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-06-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203638-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-06-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203638-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2014-06-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203638-004	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2014-06-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203638-005	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2014-06-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203638-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-06-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203638-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-06-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203638-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2014-06-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203638-004	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2014-06-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203638-005	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2014-06-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203638-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-06-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203638-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-06-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203638-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2014-06-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203638-004	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2014-06-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203638-005	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2014-06-03	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203638-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203638-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203638-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203638-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203638-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203638-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203638-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203638-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203638-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203638-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203638-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203638-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203638-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203638-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203638-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203638-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203638-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203638-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203638-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203638-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203638-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203638-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203638-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203638-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203638-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203638-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203638-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203638-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203638-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203638-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203638-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203638-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203638-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203638-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203638-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203638-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203638-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203638-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203638-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203638-005	AB	1	`5bbf6a4d5a75…`

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2024-06-19	These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS. OXYCODONE HCl tablets, for oral use, CII Initial U.S. Approval: 1950
2023-01-30	These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS. OXYCODONE HCl tablets, for oral use, CII Initial U.S. Approval: 1950
2021-02-19	These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS. OXYCODONE HCl tablets, for oral use, CII Initial U.S. Approval: 1950
2021-01-29	These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS. OXYCODONE HCl tablets, for oral use, CII Initial U.S. Approval: 1950

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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxycodone Hydrochloride	OXYCODONE	Major Pharmaceuticals	6b6db42b-9821-4aa6-8566-297037d84079	2026-07-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203638 application number: ANDA203638
Oxycodone Hydrochloride	OXYCODONE	Amneal Pharmaceuticals LLC	094b64b3-cd32-4de5-afb6-ea00d9caad74	2026-06-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203638 application number: ANDA203638
Oxycodone Hydrochloride	OXYCODONE	Redpharm Drug	525001a6-68d8-7ef7-e063-6294a90abc5f	2026-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203638 application number: ANDA203638
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Precision Dose, Inc.	f849c7cc-fa85-47eb-be30-1be137913bf9	2024-12-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203638 application number: ANDA203638
Oxycodone Hydrochloride	OXYCODONE	Bryant Ranch Prepack	b2510d72-bf63-4c9d-ac5e-7bacd993fa10	2024-05-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203638 application number: ANDA203638
Oxycodone Hydrochloride	OXYCODONE	Bryant Ranch Prepack	232d44d2-3924-4d35-873c-d2aef75e9a41	2024-05-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203638 application number: ANDA203638
Oxycodone Hydrochloride	OXYCODONE	Bryant Ranch Prepack	d248ceba-9492-4348-aa07-31c9c73a3620	2024-05-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203638 application number: ANDA203638
Oxycodone Hydrochloride	OXYCODONE	Bryant Ranch Prepack	bc7fdf7e-ad4e-4a04-b35c-2233cc7e5f15	2024-05-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203638 application number: ANDA203638
Oxycodone Hydrochloride	OXYCODONE	Bryant Ranch Prepack	4e9e945d-5ffc-48de-99fa-3fb36c5bc2b9	2024-05-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203638 application number: ANDA203638
Oxycodone Hydrochloride	OXYCODONE	Bryant Ranch Prepack	9da42120-0214-45cb-bb98-9a7739e72d43	2024-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203638 application number: ANDA203638

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
C1ENJ2TE6C	OXYCODONE HYDROCHLORIDE	124-90-3	OXYCODONE HYDROCHLORIDE
CD35PMG570	OXYCODONE	76-42-6	Oxycodone

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-5055-6	68071505506	6 TABLET in 1 BOTTLE (68071-5055-6)	6 tablet	2019-09-12	0000-00-00	No	No	Current