Oxycodone Hydrochloride

Product NDC: 0121-4839
11-digit product format: 001214839
Labeler code: 0121
Product ID: 0121-4839_d57d9fd8-8252-3c89-e053-2995a90aa9f3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oxycodone Hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: Pharmaceutical Associates, Inc.
Application: ANDA206456
Marketing category: ANDA
Marketing start: 2016-05-16
Marketing end: 0000-00-00
Substance: OXYCODONE HYDROCHLORIDE
Active strength: 5 mg/5mL
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0121-4839		D	Discontinued by firm		2026-08-03
excluded package	package	0121-4839	0121-4839-40	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0121-4839-40	`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	0121-4839-40	`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	0121-4839-40	`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	0121-4839-40	`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	0121-4839-40	`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	0121-4839-40	`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	0121-4839-40	`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	0121-4839-40	`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	0121-4839-40	`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	0121-4839-40	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0121-4839-40	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0121-4839-40	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A206456-001	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL			2015-06-16

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 2 · 41 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	A206456-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2015-06-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206456-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2015-06-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206456-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2015-06-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206456-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2015-06-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206456-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2015-06-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206456-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2015-06-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206456-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2015-06-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206456-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2015-06-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206456-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2015-06-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206456-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2015-06-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206456-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2015-06-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206456-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2015-06-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206456-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2015-06-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206456-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2015-06-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206456-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2015-06-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206456-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2015-06-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206456-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2015-06-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206456-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2015-06-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206456-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2015-06-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206456-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2015-06-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206456-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2015-06-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206456-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2015-06-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206456-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2015-06-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206456-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2015-06-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206456-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2015-06-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206456-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2015-06-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206456-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2015-06-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206456-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2015-06-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206456-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2015-06-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206456-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2015-06-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206456-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2015-06-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206456-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2015-06-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206456-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2015-06-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206456-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2015-06-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206456-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2015-06-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206456-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2015-06-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206456-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2015-06-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206456-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2015-06-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206456-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2015-06-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206456-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2015-06-16	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-04-08 23:34 UTC	2022-04	A206456-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206456-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206456-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206456-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206456-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206456-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206456-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206456-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206456-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206456-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206456-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206456-001	AA	1	`ea99ee380514…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0121-4839-40	2023-11-03	C162847	48780-1	0191ceaa-6f5a-198a-e063-dbdaa90aec3e	These highlights do not include all the information needed to use Oxycodone Hydrochloride Oral Solution, USP safely and effectively. See full prescribing information for Oxycodone Hydrochloride Oral Solution, USP. Oxycodone Hydrochloride Oral Solution, USP CII Initial U.S. Approval: 1950
0121-4839-40	2023-07-28	C162847	48780-1	0191ceaa-6f5a-198a-e063-dbdaa90aec3e	These highlights do not include all the information needed to use Oxycodone Hydrochloride Oral Solution, USP safely and effectively. See full prescribing information for Oxycodone Hydrochloride Oral Solution, USP. Oxycodone Hydrochloride Oral Solution, USP 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
0121-4839-05	ML - Milliliter	0121-4839	e1c70e09-ebfc-4a49-b5aa-50b52032760e	1	2016-07-19

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
0121-4839-40	00121483940	4 TRAY in 1 CASE (0121-4839-40) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (0121-4839-05)	4 tray	2016-05-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Oxycodone Hydrochloride	Pharmaceutical Associates, Inc. \| Morton Grove	2022-01-13	HUMAN PRESCRIPTION DRUG LABEL	6