OXYCODONE HYDROCHLORIDE

Product NDC: 55700-509
11-digit product format: 557000509
Labeler code: 55700
Product ID: 55700-509_622455fc-2653-4895-9d48-af093f9abafe
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: OXYCODONE HYDROCHLORIDE
Dosage form: TABLET
Route: ORAL
Labeler: Quality Care Products, LLC
Application: ANDA091393
Marketing category: ANDA
Marketing start: 2013-10-18
Marketing end: 0000-00-00
Substance: OXYCODONE HYDROCHLORIDE
Active strength: 20 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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	55700-509		D	Discontinued by firm	2026-08-17
excluded package	package	55700-509	55700-509-01	D	Discontinued by firm	2026-08-17
excluded package	package	55700-509	55700-509-30	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 · 33 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	55700-509-01	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55700-509-30	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	55700-509-01	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55700-509-30	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	55700-509-01	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55700-509-30	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	55700-509-01	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55700-509-30	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	55700-509-01	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55700-509-30	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	55700-509-01	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55700-509-30	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	55700-509-01	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55700-509-30	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	55700-509-01	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55700-509-30	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	55700-509-01	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55700-509-30	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55700-509-01	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55700-509-01	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55700-509-01	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		Y	Unknown FDA exclusion code: Y	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	55700-509-01	Y	Unknown FDA exclusion code: Y	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	55700-509-30	Y	Unknown FDA exclusion code: Y	`110d247fa046…`	`a55b01930146…`

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	RLD / RS	Approval date
A091393-001	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2009-08-31
A091393-002	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2009-08-31
A091393-003	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB		2009-08-31
A091393-004	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2009-08-31
A091393-005	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2009-08-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091393-001	AB
A091393-002	AB
A091393-003	AB
A091393-004	AB
A091393-005	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A091393-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2009-08-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091393-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2009-08-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091393-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB		2009-08-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091393-004	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2009-08-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091393-005	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2009-08-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091393-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2009-08-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091393-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2009-08-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091393-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB		2009-08-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091393-004	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2009-08-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091393-005	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2009-08-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091393-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2009-08-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091393-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2009-08-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091393-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB		2009-08-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091393-004	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2009-08-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091393-005	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2009-08-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091393-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2009-08-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091393-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2009-08-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091393-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB		2009-08-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091393-004	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2009-08-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091393-005	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2009-08-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091393-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2009-08-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091393-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2009-08-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091393-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB		2009-08-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091393-004	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2009-08-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091393-005	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2009-08-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091393-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2009-08-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091393-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2009-08-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091393-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB		2009-08-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091393-004	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2009-08-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091393-005	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2009-08-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091393-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2009-08-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091393-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2009-08-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091393-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB		2009-08-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091393-004	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2009-08-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091393-005	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2009-08-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091393-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2009-08-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091393-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2009-08-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091393-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB		2009-08-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091393-004	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2009-08-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091393-005	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2009-08-31	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 210 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	A091393-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091393-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091393-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091393-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091393-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091393-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091393-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091393-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091393-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091393-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091393-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091393-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091393-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091393-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091393-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091393-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091393-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091393-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091393-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091393-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091393-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091393-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091393-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091393-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091393-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091393-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091393-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091393-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091393-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091393-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091393-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091393-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091393-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091393-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091393-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091393-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091393-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091393-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091393-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091393-005	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
55700-509-01	EA - Each	55700-509	13e182a6-5384-4d12-bc44-7d7a68ba5dfc	1	2017-04-05
55700-509-30	EA - Each	55700-509	29853492-79ce-4fe0-b44d-d5862c2b9c70	1	2017-05-04

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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	3ccf459a-fb11-e137-e063-6394a90a5a80	2026-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091393 application number: ANDA091393
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	Bryant Ranch Prepack	685d9709-028e-4422-bf0c-fde577b718a2	2026-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091393 application number: ANDA091393
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	KVK-TECH,INC	e73897d6-b920-4300-a564-5dbc9c8e9fe9	2026-06-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091393 application number: ANDA091393
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	ST. MARY'S MEDICAL PARK PHARMACY	424fdfc7-1c92-2e62-e063-6394a90a136b	2026-05-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091393 application number: ANDA091393
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	American Health Packaging	aa7ac2bf-d9ed-445d-b394-4d3fe39780ca	2025-10-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091393 application number: ANDA091393
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	ST. MARY'S MEDICAL PARK PHARMACY	3cd01fb7-b59c-fc5d-e063-6394a90a21d2	2025-08-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091393 application number: ANDA091393
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	DIRECT RX	a8206207-ad09-83df-e053-2995a90a78b7	2025-06-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091393 application number: ANDA091393
Oxycodone HCL	OXYCODONE HCL	Direct_Rx	31189587-a2dc-e0a1-e063-6394a90ae17d	2025-03-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091393 application number: ANDA091393
Oxycodone Hydchloride	OXYCODONE HYDCHLORIDE	Quality Care Products LLC	b9847cc7-67a2-408d-93cf-f9cf420346dd	2024-12-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091393 application number: ANDA091393
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	Quality Care Products LLC	4cadb809-157d-49cc-97b4-3276594f19d2	2024-12-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091393 application number: ANDA091393
Oxycodone Hydchloride	OXYCODONE HYDCHLORIDE	Quality Care Products LLC	28156b13-0ba9-4dc4-be24-9c3070a7e1cc	2024-12-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091393 application number: ANDA091393
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	17f7946d-e889-b736-e063-6394a90a42e0	2024-05-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091393 application number: ANDA091393

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55700-509-01	55700050901	120 TABLET in 1 BOTTLE (55700-509-01)	120 tablet	2017-03-03	0000-00-00	No	No	Current
55700-509-30	55700050930	30 TABLET in 1 BOTTLE (55700-509-30)	30 tablet	2017-03-31	0000-00-00	No	No	Current