Oxycodone Hydrochloride

Product NDC: 0603-4991
11-digit product format: 006034991
Labeler code: 0603
Product ID: 0603-4991_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: 2007-01-31
Marketing end: 2020-02-29
Substance: OXYCODONE HYDROCHLORIDE
Active strength: 15 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#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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	0603-4991		D	Discontinued by firm	2026-08-03
excluded package	package	0603-4991	0603-4991-21	D	Discontinued by firm	2026-08-03
excluded package	package	0603-4991	0603-4991-28	D	Discontinued by firm	2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 18 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product	0603-4991		D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0603-4991	0603-4991-21	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0603-4991	0603-4991-28	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product	0603-4991		D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0603-4991	0603-4991-21	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0603-4991	0603-4991-28	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	0603-4991		D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0603-4991	0603-4991-21	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0603-4991	0603-4991-28	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product	0603-4991		D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0603-4991	0603-4991-21	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0603-4991	0603-4991-28	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product	0603-4991		D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0603-4991	0603-4991-21	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0603-4991	0603-4991-28	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product	0603-4991		D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0603-4991	0603-4991-21	D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0603-4991	0603-4991-28	D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
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 · 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	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…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077712-001	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2007-01-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077712-002	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2007-01-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077712-003	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2009-03-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077712-004	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-04-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077712-005	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2015-04-13	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 55 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	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…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077712-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077712-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077712-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077712-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077712-005	AB	1	`5bbf6a4d5a75…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0603-4991-21	EA - Each	0603-4991	bc052f2b-7bdd-4d02-ba7a-55604b908eff	1	2012-07-24
0603-4991-28	EA - Each	0603-4991	4c8cd9fb-114a-4906-a9d3-efcfd70f1d74	1	2012-07-24

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
OXYCODONE HYDROCHLORIDE	ACTIVE INGREDIENT	C1ENJ2TE6C	OXYCODONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	3
OXYCODONE	ACTIVE MOIETY	CD35PMG570	OXYCODONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	OXYCODONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	OXYCODONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	OXYCODONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	OXYCODONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	OXYCODONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	3
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	OXYCODONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	3
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	OXYCODONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	3
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	OXYCODONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	3
OXYCODONE HYDROCHLORIDE	ACTIVE INGREDIENT	C1ENJ2TE6C	OXYCODONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]	2
OXYCODONE	ACTIVE MOIETY	CD35PMG570	OXYCODONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]	2
OXYCODONE HYDROCHLORIDE	ACTIVE INGREDIENT	C1ENJ2TE6C	OXYCODONE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
OXYCODONE HYDROCHLORIDE	ACTIVE INGREDIENT	C1ENJ2TE6C	OXYCODONE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
OXYCODONE	ACTIVE MOIETY	CD35PMG570	OXYCODONE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
OXYCODONE	ACTIVE MOIETY	CD35PMG570	OXYCODONE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	OXYCODONE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	OXYCODONE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	OXYCODONE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	OXYCODONE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	OXYCODONE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	OXYCODONE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	OXYCODONE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	OXYCODONE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	OXYCODONE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	OXYCODONE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	OXYCODONE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	OXYCODONE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	OXYCODONE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	OXYCODONE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	OXYCODONE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	OXYCODONE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1

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	994dfdaa-6cf7-4177-8cea-b20b56f1512a	3
1049618	oxyCODONE HCl 30 MG Oral Tablet	PSN	994dfdaa-6cf7-4177-8cea-b20b56f1512a	3
1049621	oxyCODONE HCl 5 MG Oral Tablet	PSN	994dfdaa-6cf7-4177-8cea-b20b56f1512a	3
1049611	oxycodone hydrochloride 15 MG Oral Tablet	SCD	994dfdaa-6cf7-4177-8cea-b20b56f1512a	3
1049618	oxycodone hydrochloride 30 MG Oral Tablet	SCD	994dfdaa-6cf7-4177-8cea-b20b56f1512a	3
1049621	oxycodone hydrochloride 5 MG Oral Tablet	SCD	994dfdaa-6cf7-4177-8cea-b20b56f1512a	3
1049611	oxyCODONE HCl 15 MG Oral Tablet	PSN	3efb2cf8-9b0e-4d76-afb1-c4ecd514d534	2
1049621	oxyCODONE HCl 5 MG Oral Tablet	PSN	3efb2cf8-9b0e-4d76-afb1-c4ecd514d534	2
1049611	oxycodone hydrochloride 15 MG Oral Tablet	SCD	3efb2cf8-9b0e-4d76-afb1-c4ecd514d534	2
1049621	oxycodone hydrochloride 5 MG Oral Tablet	SCD	3efb2cf8-9b0e-4d76-afb1-c4ecd514d534	2
1049611	oxyCODONE HCl 15 MG Oral Tablet	PSN	603741db-1545-4c6f-ab7c-be9f5f42e49d	1
1049611	oxyCODONE HCl 15 MG Oral Tablet	PSN	c3ba0928-0eff-488e-8a29-fffdb1afdb60	1
1049618	oxyCODONE HCl 30 MG Oral Tablet	PSN	603741db-1545-4c6f-ab7c-be9f5f42e49d	1
1049611	oxycodone hydrochloride 15 MG Oral Tablet	SCD	603741db-1545-4c6f-ab7c-be9f5f42e49d	1
1049611	oxycodone hydrochloride 15 MG Oral Tablet	SCD	c3ba0928-0eff-488e-8a29-fffdb1afdb60	1
1049618	oxycodone hydrochloride 30 MG Oral Tablet	SCD	603741db-1545-4c6f-ab7c-be9f5f42e49d	1

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Oxycodone Hydrochloride	Par Pharmaceutical \| Par Pharmaceutical Inc.	2019-03-06	HUMAN PRESCRIPTION DRUG LABEL	16
OXYCODONE HYDROCHLORIDE - STAT Rx USA LLC \| PSS World Medical Inc.	STAT Rx USA LLC \| PSS World Medical Inc.	2012-03-02	HUMAN PRESCRIPTION DRUG LABEL	1
OXYCODONE HYDROCHLORIDE TABLETS, USP 5 mg, 15 mg, and 30 mg CII Rx only	H.J. Harkins Company, Inc. \| Vintage Pharmaceuticals-Huntsville	2011-12-15	HUMAN PRESCRIPTION DRUG LABEL	2
OXYCODONE HYDROCHLORIDE TABLETS, USP 5 mg, 15 mg, and 30 mg CII Rx only	STAT RX USA LLC	2010-08-26	HUMAN PRESCRIPTION DRUG LABEL	1
Oxycodone Hydrochloride - Physicians Total Care, Inc.	Physicians Total Care, Inc.	2010-01-11	HUMAN PRESCRIPTION DRUG LABEL	3