oxycodone hydrochloride

Product NDC: 17856-0390
11-digit product format: 178560390
Labeler code: 17856
Product ID: 17856-0390_10921ca1-7ae0-47fd-acbf-2c2ddd66afa7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: oxycodone hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: ATLANTIC BIOLOGICALS CORP.
Application: ANDA204037
Marketing category: ANDA
Marketing start: 2014-09-04
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	17856-0390		I	Inactivated by FDA		2026-08-17
excluded package	package	17856-0390	17856-0390-2	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 1 · 4 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
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	17856-0390-2	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	17856-0390-2	`1332a3947898…`	`d4bfe170f9cd…`

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
A204037-001	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RS	2013-07-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204037-001	AA

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A204037-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RS	2013-07-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204037-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RS	2013-07-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204037-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RS	2013-07-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204037-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RS	2013-07-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204037-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RS	2013-07-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204037-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RS	2013-07-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204037-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RS	2013-07-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204037-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RS	2013-07-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204037-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RS	2013-07-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204037-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RS	2013-07-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204037-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RS	2013-07-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204037-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RS	2013-07-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204037-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RS	2013-07-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204037-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RS	2013-07-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204037-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RS	2013-07-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204037-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA		2013-07-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204037-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA		2013-07-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204037-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA		2013-07-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204037-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA		2013-07-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204037-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA		2013-07-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204037-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA		2013-07-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204037-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA		2013-07-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204037-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA		2013-07-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204037-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA		2013-07-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204037-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA		2013-07-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204037-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA		2013-07-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204037-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA		2013-07-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204037-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA		2013-07-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204037-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RS	2013-07-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204037-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RS	2013-07-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204037-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA		2013-07-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204037-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA		2013-07-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204037-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA		2013-07-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204037-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA		2013-07-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204037-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA		2013-07-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204037-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA		2013-07-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204037-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA		2013-07-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204037-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA		2013-07-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204037-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA		2013-07-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204037-001	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA		2013-07-15	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A204037-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204037-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204037-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204037-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204037-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204037-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204037-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204037-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204037-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204037-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204037-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204037-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204037-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204037-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204037-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204037-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204037-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204037-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204037-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204037-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204037-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204037-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204037-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204037-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204037-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204037-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204037-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204037-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204037-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204037-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204037-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204037-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204037-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204037-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204037-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204037-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204037-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204037-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204037-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204037-001	AA	1	`e64feba35796…`

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, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
17856-0390-2	2024-05-15	C162847	48780-1	1030e365-0916-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use OXYCODONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for OXYCODONE HYDROCHLORIDE ORAL SOLUTION. OXYCODONE HYDROCHLORIDE oral solution CII Initial U.S. Approval: 1950
17856-0390-2	2024-01-30	C162847	48780-1	1030e365-0916-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use OXYCODONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for OXYCODONE HYDROCHLORIDE ORAL SOLUTION. OXYCODONE HYDROCHLORIDE oral solution CII Initial U.S. Approval: 1950

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
17856-0390-1	oxycodone hydrochloride	72 in 1 CUP, UNIT-DOSE	SOLUTION	72	3
17856-0390-1	oxycodone hydrochloride	5 mL in 1 CUP, UNIT-DOSE	SOLUTION	5	3
17856-0390-2	oxycodone hydrochloride	1 in 1 CUP, UNIT-DOSE	SOLUTION	1	3
17856-0390-3	oxycodone hydrochloride	5 in 1 CUP, UNIT-DOSE	SOLUTION	5	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17856-0390	OXYCODONE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORP.]	3	Legacy NDC, 4 package rows	20240517_fd7aece9-2c25-4ec7-9abb-427e8c176aa8.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
oxycodone hydrochloride	OXYCODONE HYDROCHLORIDE	Hikma Pharmceuticals USA Inc.	d8e87c66-f872-4e1d-9ade-ef11490af63b	2026-01-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204037 application number: ANDA204037
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	American Health Packaging	0a6b0659-6816-4f44-81bd-9bac4da5380d	2025-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204037 application number: ANDA204037

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
1049604	oxyCODONE HCl 5 MG in 5 mL Oral Solution	PSN	fd7aece9-2c25-4ec7-9abb-427e8c176aa8	3
1049604	oxycodone hydrochloride 1 MG/ML Oral Solution	SCD	fd7aece9-2c25-4ec7-9abb-427e8c176aa8	3
1049604	oxycodone hydrochloride 5 MG per 5 ML Oral Solution	SY	fd7aece9-2c25-4ec7-9abb-427e8c176aa8	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
17856-0390-1	17856039001	72 CUP, UNIT-DOSE in 1 CUP, UNIT-DOSE (17856-0390-1) > 5 mL in 1 CUP, UNIT-DOSE	2021-04-12	0000-00-00	No	No	Current
17856-0390-2	17856039002	1 CUP, UNIT-DOSE in 1 CUP, UNIT-DOSE (17856-0390-2) > 5 CUP, UNIT-DOSE in 1 CUP, UNIT-DOSE (17856-0390-3) > 72 CUP, UNIT-DOSE in 1 CUP, UNIT-DOSE (17856-0390-1) > 5 mL in 1 CUP, UNIT-DOSE	2022-08-30	0000-00-00	No	No	Current
17856-0390-3	17856039003	5 in 1 CUP, UNIT-DOSE					Historical