OXYCODONE HYDROCHLORIDE

Product NDC: 63629-4606
11-digit product format: 636294606
Labeler code: 63629
Product ID: 63629-4606_e0424639-94d0-41dd-b656-4cdb08b310da
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: OXYCODONE HYDROCHLORIDE
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA077290
Marketing category: ANDA
Marketing start: 2012-12-26
Marketing end: 0000-00-00
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: 2023-12-31
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 · 7 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	63629-4606		D	Discontinued by firm	2026-08-17
excluded package	package	63629-4606	63629-4606-1	D	Discontinued by firm	2026-08-17
excluded package	package	63629-4606	63629-4606-2	D	Discontinued by firm	2026-08-17
excluded package	package	63629-4606	63629-4606-3	D	Discontinued by firm	2026-08-17
excluded package	package	63629-4606	63629-4606-4	D	Discontinued by firm	2026-08-17
excluded package	package	63629-4606	63629-4606-5	D	Discontinued by firm	2026-08-17
excluded package	package	63629-4606	63629-4606-6	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 2 · 91 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	63629-4606-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-4606-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-4606-6	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-4606-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-4606-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-4606-5	`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	63629-4606-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-4606-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-4606-6	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-4606-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-4606-4	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-4606-5	`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	63629-4606-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-4606-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-4606-6	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-4606-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-4606-4	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-4606-5	`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	63629-4606-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-4606-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-4606-6	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-4606-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-4606-4	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-4606-5	`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	63629-4606-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-4606-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-4606-6	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-4606-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-4606-4	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-4606-5	`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	63629-4606-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-4606-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-4606-6	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-4606-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-4606-4	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-4606-5	`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	63629-4606-2	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-4606-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-4606-6	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-4606-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-4606-4	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-4606-5	`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	63629-4606-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-4606-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-4606-6	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-4606-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-4606-4	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-4606-5	`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	63629-4606-2	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-4606-1	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-4606-6	`0efc9e666f02…`	`f202fb6c5f17…`

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	Approval date
A077290-001	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	2005-12-08
A077290-002	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	2005-12-08
A077290-003	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	2005-12-08
A077290-004	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	2005-12-08
A077290-005	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	2005-12-08

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A077290-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	2005-12-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077290-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	2005-12-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077290-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	2005-12-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077290-004	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	2005-12-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077290-005	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	2005-12-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077290-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	2005-12-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077290-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	2005-12-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077290-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	2005-12-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077290-004	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	2005-12-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077290-005	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	2005-12-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077290-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	2005-12-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077290-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	2005-12-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077290-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	2005-12-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077290-004	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	2005-12-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077290-005	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	2005-12-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077290-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	2005-12-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077290-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	2005-12-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077290-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	2005-12-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077290-004	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	2005-12-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077290-005	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	2005-12-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077290-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	2005-12-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077290-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	2005-12-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077290-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	2005-12-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077290-004	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	2005-12-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077290-005	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	2005-12-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077290-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	2005-12-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077290-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	2005-12-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077290-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	2005-12-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077290-004	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	2005-12-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077290-005	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	2005-12-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077290-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	2005-12-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077290-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	2005-12-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077290-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	2005-12-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077290-004	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	2005-12-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077290-005	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	2005-12-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077290-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	2005-12-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077290-002	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	2005-12-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077290-003	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	2005-12-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077290-004	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	2005-12-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077290-005	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	2005-12-08	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A077290-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077290-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077290-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077290-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077290-005	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A077290-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077290-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077290-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077290-004	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077290-005	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077290-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077290-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077290-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077290-004	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077290-005	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077290-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077290-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077290-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077290-004	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077290-005	AB	1	`ea99ee380514…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63629-4606-1	2020-10-16	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 CII Initial U.S. Approval: 1950
63629-4606-2	2020-10-16	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 CII Initial U.S. Approval: 1950
63629-4606-3	2020-10-16	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 CII Initial U.S. Approval: 1950
63629-4606-4	2020-10-16	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 CII Initial U.S. Approval: 1950
63629-4606-5	2020-10-16	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 CII Initial U.S. Approval: 1950
63629-4606-6	2020-10-16	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 CII Initial U.S. Approval: 1950
63629-4606-1	2020-01-31	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 CII Initial U.S. Approval: 1950
63629-4606-2	2020-01-31	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 CII Initial U.S. Approval: 1950
63629-4606-3	2020-01-31	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 CII Initial U.S. Approval: 1950
63629-4606-4	2020-01-31	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 CII Initial U.S. Approval: 1950
63629-4606-5	2020-01-31	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 CII Initial U.S. Approval: 1950
63629-4606-6	2020-01-31	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 CII Initial U.S. Approval: 1950

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-4606-1	EA - Each	63629-4606	1a58316b-a7ce-4512-9e20-98e1bf6ba5da	1	2023-09-05
63629-4606-2	EA - Each	63629-4606	725875c1-2e3b-499a-9776-c2705636de89	1	2016-05-16
63629-4606-3	EA - Each	63629-4606	de66e426-9d7c-4b40-a8b7-3fc7afecb21e	1	2016-05-16
63629-4606-4	EA - Each	63629-4606	2ef72a84-1890-45ea-96a2-539e3a9eb1e7	1	2023-09-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OXYCODONE HYDROCHLORIDE	ACTIVE INGREDIENT	C1ENJ2TE6C	OXYCODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]	1000
OXYCODONE	ACTIVE MOIETY	CD35PMG570	OXYCODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]	1000
ALUMINUM HYDROXIDE	INACTIVE INGREDIENT	5QB0T2IUN0	OXYCODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]	1000
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	OXYCODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]	1000
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	OXYCODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]	1000
D&C RED NO. 30	INACTIVE INGREDIENT	2S42T2808B	OXYCODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]	1000
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	OXYCODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]	1000
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	OXYCODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]	1000
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	OXYCODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]	1000

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
63629-4606-1	63629460601	120 TABLET in 1 BOTTLE (63629-4606-1)	120 tablet	2012-12-26	0000-00-00	No	No	Current
63629-4606-2	63629460602	30 TABLET in 1 BOTTLE (63629-4606-2)	30 tablet	2012-12-26	0000-00-00	No	No	Current
63629-4606-3	63629460603	60 TABLET in 1 BOTTLE (63629-4606-3)	60 tablet	2012-12-26	0000-00-00	No	No	Current
63629-4606-4	63629460604	90 TABLET in 1 BOTTLE (63629-4606-4)	90 tablet	2012-12-26	0000-00-00	No	No	Current
63629-4606-5	63629460605	40 TABLET in 1 BOTTLE (63629-4606-5)	40 tablet	2012-12-26	0000-00-00	No	No	Current
63629-4606-6	63629460606	28 TABLET in 1 BOTTLE (63629-4606-6)	28 tablet	2012-12-26	0000-00-00	No	No	Current