oxycodone hydrochloride

Product NDC: 67296-1040
Requested package NDC: 67296-1040-2
11-digit product format: 672961040
Labeler code: 67296
Product ID: 67296-1040_d60f91b5-252f-145d-e053-2995a90af686
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: oxycodone hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: RedPharm Drug, Inc.
Application: ANDA090659
Marketing category: ANDA
Marketing start: 2009-05-12
Marketing end: 0000-00-00
Substance: OXYCODONE HYDROCHLORIDE
Active strength: 5 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	67296-1040	67296-1040-2	I	Inactivated by FDA		2026-10-05

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 · 3 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67296-1040	67296-1040-2	E	Excluded after deficient or non-compliant submission was not corrected	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67296-1040	67296-1040-2	E	Excluded after deficient or non-compliant submission was not corrected	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	67296-1040	67296-1040-2	E	Excluded after deficient or non-compliant submission was not corrected	excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A090659-001	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	2009-04-10
A090659-002	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	2009-04-10
A090659-003	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	2009-04-10
A090659-004	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	2012-11-06
A090659-005	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	2012-11-06

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 · 215 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A090659-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	2009-04-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090659-002	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	2009-04-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090659-003	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	2009-04-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090659-004	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	2012-11-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090659-005	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	2012-11-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090659-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	2009-04-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090659-002	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	2009-04-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090659-003	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	2009-04-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090659-004	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	2012-11-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090659-005	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	2012-11-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090659-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	2009-04-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090659-002	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	2009-04-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090659-003	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	2009-04-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090659-004	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	2012-11-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090659-005	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	2012-11-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090659-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	2009-04-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090659-002	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	2009-04-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090659-003	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	2009-04-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090659-004	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	2012-11-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090659-005	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	2012-11-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090659-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	2009-04-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090659-002	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	2009-04-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090659-003	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	2009-04-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090659-004	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	2012-11-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090659-005	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	2012-11-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090659-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	2009-04-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090659-002	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	2009-04-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090659-003	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	2009-04-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090659-004	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	2012-11-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090659-005	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	2012-11-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090659-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	2009-04-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090659-002	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	2009-04-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090659-003	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	2009-04-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090659-004	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	2012-11-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090659-005	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	2012-11-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090659-001	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	2009-04-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090659-002	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	2009-04-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090659-003	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	2009-04-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090659-004	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	2012-11-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090659-005	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	2012-11-06	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 140 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090659-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090659-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090659-003	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090659-004	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090659-005	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090659-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090659-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090659-003	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090659-004	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090659-005	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090659-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090659-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090659-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090659-004	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090659-005	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090659-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090659-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090659-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090659-004	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090659-005	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090659-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090659-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090659-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090659-004	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090659-005	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090659-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090659-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090659-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090659-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090659-005	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090659-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090659-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090659-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090659-004	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090659-005	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090659-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090659-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090659-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090659-004	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090659-005	AB	1	`782e0a99824c…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67296-1040-2	oxycodone hydrochloride	20 in 1 BOTTLE	TABLET	20		4
67296-1040-4	oxycodone hydrochloride	40 in 1 BOTTLE	TABLET	40		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67296-1040	OXYCODONE HYDROCHLORIDE TABLET [REDPHARM DRUG, INC.]	4	Legacy NDC, 2 package rows	20240117_4e3c2507-3f3e-39a5-e054-00144ff8d46c.zip

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
1049621	oxyCODONE HCl 5 MG Oral Tablet	PSN	4e3c2507-3f3e-39a5-e054-00144ff8d46c	4
1049621	oxycodone hydrochloride 5 MG Oral Tablet	SCD	4e3c2507-3f3e-39a5-e054-00144ff8d46c	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67296-1040-2	67296104002	20 TABLET in 1 BOTTLE (67296-1040-2)	20 tablet	2009-05-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
oxycodone hydrochloride - RedPharm Drug, Inc.	RedPharm Drug, Inc.	2024-01-15	HUMAN PRESCRIPTION DRUG LABEL	4