OXYCODONE HYDROCHLORIDE

Product NDC: 10544-599
11-digit product format: 105440599
Labeler code: 10544
Product ID: 10544-599_4bae713c-47eb-4cdd-b727-3b4ec81825ae
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: oxycodone hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Blenheim Pharmacal, Inc.
Application: ANDA076758
Marketing category: ANDA
Marketing start: 2010-04-06
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: E
Listing certified through: 2017-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	10544-599		I	Inactivated by FDA	2026-08-17
excluded package	package	10544-599	10544-599-02	I	Inactivated by FDA	2026-08-17
excluded package	package	10544-599	10544-599-30	I	Inactivated by FDA	2026-08-17
excluded package	package	10544-599	10544-599-55	I	Inactivated by FDA	2026-08-17
excluded package	package	10544-599	10544-599-60	I	Inactivated by FDA	2026-08-17
excluded package	package	10544-599	10544-599-90	I	Inactivated by FDA	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 3 · 132 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	10544-599-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10544-599-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10544-599-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10544-599-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10544-599-55	`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	10544-599-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10544-599-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10544-599-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10544-599-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10544-599-55	`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	10544-599-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10544-599-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10544-599-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10544-599-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10544-599-55	`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	10544-599-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10544-599-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10544-599-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10544-599-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10544-599-55	`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	10544-599-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10544-599-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10544-599-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10544-599-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10544-599-55	`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	10544-599-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10544-599-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10544-599-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10544-599-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10544-599-55	`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	10544-599-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10544-599-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10544-599-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10544-599-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10544-599-55	`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	10544-599-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10544-599-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10544-599-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10544-599-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10544-599-55	`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	10544-599-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10544-599-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10544-599-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10544-599-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10544-599-55	`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	10544-599-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10544-599-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10544-599-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10544-599-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10544-599-55	`ad56d346431e…`	`cc804d4bbf1e…`

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
A076758-001	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2004-06-30
A076758-002	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2004-06-30
A076758-003	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2007-03-19
A076758-004	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-10-12
A076758-005	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2021-10-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076758-001	AB
A076758-002	AB
A076758-003	AB
A076758-004	AB
A076758-005	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 5 · 194 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	A076758-001	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2004-06-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076758-002	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2004-06-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076758-003	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2007-03-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076758-004	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-10-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076758-005	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2021-10-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076758-001	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2004-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076758-002	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2004-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076758-003	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2007-03-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076758-004	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-10-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076758-005	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2021-10-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076758-001	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2004-06-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076758-002	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2004-06-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076758-003	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2007-03-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076758-004	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-10-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076758-005	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2021-10-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076758-001	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2004-06-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076758-002	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2004-06-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076758-003	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2007-03-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076758-004	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-10-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076758-005	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2021-10-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076758-001	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2004-06-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076758-002	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2004-06-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076758-003	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2007-03-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076758-004	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-10-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076758-005	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2021-10-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076758-001	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2004-06-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076758-002	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2004-06-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076758-003	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2007-03-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076758-004	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-10-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076758-005	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2021-10-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076758-001	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2004-06-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076758-002	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2004-06-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076758-003	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2007-03-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076758-004	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-10-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076758-005	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2021-10-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076758-001	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2004-06-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076758-002	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2004-06-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076758-003	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2007-03-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076758-004	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-10-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076758-005	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2021-10-12	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 194 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	A076758-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076758-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076758-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076758-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076758-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076758-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076758-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076758-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076758-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076758-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076758-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076758-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076758-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076758-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076758-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076758-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076758-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076758-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076758-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076758-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076758-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076758-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076758-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076758-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076758-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076758-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076758-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076758-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076758-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076758-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076758-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076758-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076758-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076758-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076758-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076758-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076758-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076758-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076758-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076758-005	AB	1	`2680178bc6a6…`

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, Related label table
NDC	Related label
10544-599-02	OXYCODONE HYDROCHLORIDE Tablets USP CII 5 mg, 15 mg, & 30 mg Rx only
10544-599-30	OXYCODONE HYDROCHLORIDE Tablets USP CII 5 mg, 15 mg, & 30 mg Rx only
10544-599-55	OXYCODONE HYDROCHLORIDE Tablets USP CII 5 mg, 15 mg, & 30 mg Rx only
10544-599-60	OXYCODONE HYDROCHLORIDE Tablets USP CII 5 mg, 15 mg, & 30 mg Rx only
10544-599-90	OXYCODONE HYDROCHLORIDE Tablets USP CII 5 mg, 15 mg, & 30 mg Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
10544-599-02	OXYCODONE HYDROCHLORIDE	120 in 1 BOTTLE	TABLET	120	2
10544-599-30	OXYCODONE HYDROCHLORIDE	30 in 1 BOTTLE	TABLET	30	2
10544-599-55	OXYCODONE HYDROCHLORIDE	150 in 1 BOTTLE	TABLET	150	2
10544-599-60	OXYCODONE HYDROCHLORIDE	60 in 1 BOTTLE	TABLET	60	2
10544-599-90	OXYCODONE HYDROCHLORIDE	90 in 1 BOTTLE	TABLET	90	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10544-599-02	EA - Each	10544-599	5feaf87f-ebda-43b6-a447-925603d25d96	1	2015-10-02
10544-599-30	EA - Each	10544-599	276d06e5-da81-47a1-b00a-d8f571721bfb	1	2015-10-02
10544-599-55	EA - Each	10544-599	34257e1d-360f-4eaf-8e5e-edf066ee4412	1	2015-10-02
10544-599-60	EA - Each	10544-599	86cdc5d3-827b-4b34-a499-90e67fb22cac	1	2015-10-02
10544-599-90	EA - Each	10544-599	fae1c063-c167-43a4-b051-27f0b86b0aeb	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OXYCODONE HYDROCHLORIDE	ACTIVE INGREDIENT	C1ENJ2TE6C	OXYCODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	2
OXYCODONE	ACTIVE MOIETY	CD35PMG570	OXYCODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	OXYCODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	OXYCODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	OXYCODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	OXYCODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	OXYCODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10544-599	OXYCODONE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	2	Legacy NDC, 5 package rows	20100825_a7a7ba28-78c5-453e-a101-61c6afa40216.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	SpecGx LLC	928227bf-89c5-4c64-9823-0e84cc669388	2026-08-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076758 application number: ANDA076758
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	Redpharm Drug	5301d432-7fca-2d72-e063-6394a90a18a4	2026-05-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076758 application number: ANDA076758
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	RedPharm Drug, Inc.	92614a3a-331d-16ad-e053-2a95a90a47cc	2025-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076758 application number: ANDA076758

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
1049611	oxyCODONE HCl 15 MG Oral Tablet	PSN	a7a7ba28-78c5-453e-a101-61c6afa40216	2
1049618	oxyCODONE HCl 30 MG Oral Tablet	PSN	a7a7ba28-78c5-453e-a101-61c6afa40216	2
1049611	oxycodone hydrochloride 15 MG Oral Tablet	SCD	a7a7ba28-78c5-453e-a101-61c6afa40216	2
1049618	oxycodone hydrochloride 30 MG Oral Tablet	SCD	a7a7ba28-78c5-453e-a101-61c6afa40216	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
10544-599-02	10544059902	120 in 1 BOTTLE	Historical
10544-599-30	10544059930	30 in 1 BOTTLE	Historical
10544-599-55	10544059955	150 in 1 BOTTLE	Historical
10544-599-60	10544059960	60 in 1 BOTTLE	Historical
10544-599-90	10544059990	90 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
OXYCODONE HYDROCHLORIDE Tablets USP CII 5 mg, 15 mg, & 30 mg Rx only	Blenheim Pharmacal, Inc.	2010-08-25	HUMAN PRESCRIPTION DRUG LABEL	2