Oxycodone Hydrochloride

Product NDC: 0054-0393
11-digit product format: 000540393
Labeler code: 0054
Product ID: 0054-0393_303f1bfc-a6d1-4020-96f8-91d095a1e2a9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oxycodone Hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: West-Ward Pharmaceuticals Corp.
Application: ANDA203208
Marketing category: ANDA
Marketing start: 2014-09-04
Marketing end: 2020-08-31
Substance: OXYCODONE HYDROCHLORIDE
Active strength: 100 mg/5mL
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#

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	0054-0393		D	Discontinued by firm		2026-08-17
excluded package	package	0054-0393	0054-0393-44	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 · 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	0054-0393-44	`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	0054-0393-44	`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	0054-0393-44	`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	0054-0393-44	`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	0054-0393-44	`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	0054-0393-44	`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	0054-0393-44	`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	0054-0393-44	`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	0054-0393-44	`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	0054-0393-44	`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	0054-0393-44	`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	0054-0393-44	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A203208-001	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL			2013-07-12

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 · 42 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	A203208-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2013-07-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203208-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2013-07-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203208-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2013-07-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203208-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2013-07-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203208-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2013-07-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203208-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2013-07-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203208-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2013-07-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203208-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2013-07-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203208-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2013-07-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203208-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2013-07-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203208-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2013-07-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203208-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2013-07-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203208-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2013-07-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203208-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2013-07-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203208-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2013-07-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203208-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2013-07-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203208-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2013-07-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203208-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2013-07-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203208-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2013-07-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203208-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2013-07-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203208-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2013-07-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203208-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2013-07-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203208-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2013-07-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203208-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2013-07-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203208-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2013-07-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203208-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2013-07-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203208-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2013-07-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203208-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL	AA	2013-07-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203208-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2013-07-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203208-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2013-07-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203208-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2013-07-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203208-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2013-07-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203208-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2013-07-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203208-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2013-07-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203208-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2013-07-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203208-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2013-07-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203208-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2013-07-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203208-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2013-07-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203208-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2013-07-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203208-001	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION / ORAL		2013-07-12	`e64feba35796…`

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	A203208-001	AA	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A203208-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203208-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203208-001	AA	1	`ea99ee380514…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
92ead9ae-674d-4eee-a492-c385d496891f	Product name	3	20220308
b8cd3792-f010-440e-ac63-7713119fde04	Product name	9	20220110
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
bde672ba-4805-28d0-1986-73543d41b412	Product name	2	20210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
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
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
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
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
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
0054-0393-44	ML - Milliliter	0054-0393	09712188-07a4-4f0b-8efb-3bf3ee8ff000	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 SOLUTION [ROXANE LABORATORIES, INC.]	1
OXYCODONE	ACTIVE MOIETY	CD35PMG570	OXYCODONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC.]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	OXYCODONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC.]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	OXYCODONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC.]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	OXYCODONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC.]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	OXYCODONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC.]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	OXYCODONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC.]	1
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	OXYCODONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	OXYCODONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC.]	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
1049615	oxyCODONE HCl 20 MG in 1 mL Concentrate for Oral Solution	PSN	438290e4-3c2a-4bc4-b08b-37f107fc20d2	2
1049615	oxycodone hydrochloride 20 MG/ML Oral Solution	SCD	438290e4-3c2a-4bc4-b08b-37f107fc20d2	2
1049615	oxycodone hydrochloride 20 MG per 1 ML Concentrate for Oral Solution	SY	438290e4-3c2a-4bc4-b08b-37f107fc20d2	2

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Oxycodone Hydrochloride	West-Ward Pharmaceuticals Corp. \| West-Ward Columbus Inc.	2020-04-14	HUMAN PRESCRIPTION DRUG LABEL	8
Oxycodone Hydrochloride	Atlantic Biologicals Corps	2016-06-29	HUMAN PRESCRIPTION DRUG LABEL	2