Oxycodone Hydrochloride

Product NDC: 0603-4993
11-digit product format: 006034993
Labeler code: 0603
Product ID: 0603-4993_54873134-c3ba-43c2-98b1-df36c08c74d0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oxycodone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Par Pharmaceutical
Application: ANDA077712
Marketing category: ANDA
Marketing start: 2015-04-13
Marketing end: 2020-02-29
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: 0000-00-00
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	0603-4993		D	Discontinued by firm		2026-08-17
excluded package	package	0603-4993	0603-4993-21	D	Discontinued by firm		2026-08-17

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	0603-4993-21	`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	0603-4993-21	`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	0603-4993-21	`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	0603-4993-21	`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	0603-4993-21	`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	0603-4993-21	`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	0603-4993-21	`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	0603-4993-21	`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	0603-4993-21	`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	0603-4993-21	`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	0603-4993-21	`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	0603-4993-21	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A077712-001	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2007-01-31
A077712-002	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-01-31
A077712-003	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2009-03-02
A077712-004	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-04-13
A077712-005	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2015-04-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077712-001	AB
A077712-002	AB
A077712-003	AB
A077712-004	AB
A077712-005	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 · 210 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
2026-08-18 06:07:40	2026-07	A077712-001	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2007-01-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077712-002	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-01-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077712-003	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2009-03-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077712-004	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-04-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077712-005	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2015-04-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077712-001	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2007-01-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077712-002	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-01-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077712-003	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2009-03-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077712-004	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-04-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077712-005	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2015-04-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077712-001	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2007-01-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077712-002	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-01-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077712-003	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2009-03-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077712-004	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-04-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077712-005	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2015-04-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077712-001	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2007-01-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077712-002	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-01-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077712-003	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2009-03-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077712-004	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-04-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077712-005	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2015-04-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077712-001	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2007-01-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077712-002	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-01-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077712-003	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2009-03-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077712-004	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-04-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077712-005	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2015-04-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077712-001	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2007-01-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077712-002	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-01-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077712-003	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2009-03-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077712-004	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-04-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077712-005	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2015-04-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077712-001	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2007-01-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077712-002	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-01-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077712-003	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2009-03-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077712-004	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-04-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077712-005	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2015-04-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077712-001	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2007-01-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077712-002	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-01-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077712-003	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2009-03-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077712-004	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-04-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077712-005	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2015-04-13	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 60 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A077712-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077712-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077712-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077712-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077712-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077712-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077712-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077712-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077712-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077712-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077712-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077712-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077712-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077712-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077712-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077712-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077712-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077712-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077712-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077712-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077712-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077712-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077712-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077712-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077712-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077712-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077712-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077712-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077712-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077712-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077712-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077712-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077712-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077712-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077712-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077712-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077712-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077712-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077712-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077712-005	AB	1	`2680178bc6a6…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0603-4993-21	EA - Each	0603-4993	b9eba462-434f-4b89-b1e3-9537e7747ca2	1	2015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OXYCODONE HYDROCHLORIDE	ACTIVE INGREDIENT	C1ENJ2TE6C	OXYCODONE HYDROCHLORIDE TABLET [QUALITEST PHARMACEUTICALS]	9
OXYCODONE	ACTIVE MOIETY	CD35PMG570	OXYCODONE HYDROCHLORIDE TABLET [QUALITEST PHARMACEUTICALS]	9
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	OXYCODONE HYDROCHLORIDE TABLET [QUALITEST PHARMACEUTICALS]	9
D&C RED NO. 30	INACTIVE INGREDIENT	2S42T2808B	OXYCODONE HYDROCHLORIDE TABLET [QUALITEST PHARMACEUTICALS]	9
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	OXYCODONE HYDROCHLORIDE TABLET [QUALITEST PHARMACEUTICALS]	9
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	OXYCODONE HYDROCHLORIDE TABLET [QUALITEST PHARMACEUTICALS]	9
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	OXYCODONE HYDROCHLORIDE TABLET [QUALITEST PHARMACEUTICALS]	9
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	OXYCODONE HYDROCHLORIDE TABLET [QUALITEST PHARMACEUTICALS]	9
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	OXYCODONE HYDROCHLORIDE TABLET [QUALITEST PHARMACEUTICALS]	9
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	OXYCODONE HYDROCHLORIDE TABLET [QUALITEST PHARMACEUTICALS]	9
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	OXYCODONE HYDROCHLORIDE TABLET [QUALITEST PHARMACEUTICALS]	9
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	OXYCODONE HYDROCHLORIDE TABLET [QUALITEST PHARMACEUTICALS]	9
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	OXYCODONE HYDROCHLORIDE TABLET [QUALITEST PHARMACEUTICALS]	9
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	OXYCODONE HYDROCHLORIDE TABLET [QUALITEST PHARMACEUTICALS]	9

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Strides Pharma Science Limited	f3116ebf-d72c-4e98-aa50-006be4770c86	2026-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077712 application number: ANDA077712
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Asclemed USA, Inc.	056bdaac-4a43-42f0-9435-f349d3ccc128	2025-12-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077712 application number: ANDA077712
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Redpharm Drug	439c2de6-3ea5-e829-e063-6294a90aa77d	2025-12-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077712 application number: ANDA077712
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Bryant Ranch Prepack	08977126-9671-4d87-9724-1599ca86e181	2025-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077712 application number: ANDA077712
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	ST. MARY'S MEDICAL PARK PHARMACY	3ca9f0d9-a40d-4416-e063-6394a90aec8b	2025-08-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077712 application number: ANDA077712
Oxycodone HCL	OXYCODONE HCL	Direct_Rx	3245cd2f-8ad0-b755-e063-6394a90a603c	2025-07-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077712 application number: ANDA077712
Oxycodone HCL	OXYCODONE HCL	Direct_Rx	3a849aeb-b72c-5cde-e063-6394a90a9768	2025-07-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077712 application number: ANDA077712
Oxycodone HCL	OXYCODONE HCL	Direct_Rx	32323565-5add-96a9-e063-6294a90a5b4e	2025-04-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077712 application number: ANDA077712
Oxycodone HCL	OXYCODONE HCL	Direct_Rx	323148b2-809a-db11-e063-6294a90abe36	2025-04-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077712 application number: ANDA077712

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
OXYCODONE HYDROCHLORIDE TABLETS, USP 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg CII Rx only	Major Pharmaceuticals	2019-12-10	HUMAN PRESCRIPTION DRUG LABEL	2
Oxycodone Hydrochloride	Par Pharmaceutical \| Par Pharmaceutical Inc.	2019-03-06	HUMAN PRESCRIPTION DRUG LABEL	16