OXAYDO

Product NDC: 69344-213
11-digit product format: 693440213
Labeler code: 69344
Product ID: 69344-213_5ab321c4-697f-4614-87bb-ec31a1429ef8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: OXYCODONE HYDROCHLORIDE
Dosage form: TABLET
Route: ORAL
Labeler: Zyla Life Sciences US LLC
Application: NDA202080
Marketing category: NDA
Marketing start: 2015-09-01
Substance: OXYCODONE HYDROCHLORIDE
Active strength: 7.5 mg/1
Pharmacologic classes: Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N202080-001	OXAYDO	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL		RLD	2011-06-17
N202080-002	OXAYDO	OXYCODONE HYDROCHLORIDE	7.5MG	TABLET / ORAL		RLD	2011-06-17

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 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N202080-001	OXAYDO	5MG	TABLET / ORAL	RLD	2011-06-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202080-002	OXAYDO	7.5MG	TABLET / ORAL	RLD	2011-06-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N202080-001	OXAYDO	5MG	TABLET / ORAL	RLD	2011-06-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202080-002	OXAYDO	7.5MG	TABLET / ORAL	RLD	2011-06-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202080-001	OXAYDO	5MG	TABLET / ORAL	RLD	2011-06-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202080-002	OXAYDO	7.5MG	TABLET / ORAL	RLD	2011-06-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202080-001	OXAYDO	5MG	TABLET / ORAL	RLD	2011-06-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202080-002	OXAYDO	7.5MG	TABLET / ORAL	RLD	2011-06-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202080-001	OXAYDO	5MG	TABLET / ORAL	RLD	2011-06-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202080-002	OXAYDO	7.5MG	TABLET / ORAL	RLD	2011-06-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202080-001	OXAYDO	5MG	TABLET / ORAL	RLD	2011-06-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202080-002	OXAYDO	7.5MG	TABLET / ORAL	RLD	2011-06-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202080-001	OXAYDO	5MG	TABLET / ORAL	RLD	2011-06-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202080-002	OXAYDO	7.5MG	TABLET / ORAL	RLD	2011-06-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202080-001	OXAYDO	5MG	TABLET / ORAL	RLD	2011-06-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202080-002	OXAYDO	7.5MG	TABLET / ORAL	RLD	2011-06-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202080-001	OXAYDO	5MG	TABLET / ORAL	RLD	2011-06-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202080-002	OXAYDO	7.5MG	TABLET / ORAL	RLD	2011-06-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202080-001	OXAYDO	5MG	TABLET / ORAL	RLD	2011-06-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202080-002	OXAYDO	7.5MG	TABLET / ORAL	RLD	2011-06-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202080-001	OXAYDO	5MG	TABLET / ORAL	RLD	2011-06-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202080-002	OXAYDO	7.5MG	TABLET / ORAL	RLD	2011-06-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202080-001	OXAYDO	5MG	TABLET / ORAL	RLD	2011-06-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202080-002	OXAYDO	7.5MG	TABLET / ORAL	RLD	2011-06-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202080-001	OXAYDO	5MG	TABLET / ORAL	RLD	2011-06-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202080-002	OXAYDO	7.5MG	TABLET / ORAL	RLD	2011-06-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202080-001	OXAYDO	5MG	TABLET / ORAL	RLD	2011-06-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202080-002	OXAYDO	7.5MG	TABLET / ORAL	RLD	2011-06-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202080-001	OXAYDO	5MG	TABLET / ORAL	RLD	2011-06-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N202080-002	OXAYDO	7.5MG	TABLET / ORAL	RLD	2011-06-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202080-001	OXAYDO	5MG	TABLET / ORAL	RLD	2011-06-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202080-002	OXAYDO	7.5MG	TABLET / ORAL	RLD	2011-06-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N202080-001	OXAYDO	5MG	TABLET / ORAL	RLD	2011-06-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N202080-002	OXAYDO	7.5MG	TABLET / ORAL	RLD	2011-06-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N202080-001	OXAYDO	5MG	TABLET / ORAL	RLD	2011-06-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N202080-002	OXAYDO	7.5MG	TABLET / ORAL	RLD	2011-06-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N202080-001	OXAYDO	5MG	TABLET / ORAL		2011-06-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N202080-002	OXAYDO	7.5MG	TABLET / ORAL		2011-06-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N202080-001	OXAYDO	5MG	TABLET / ORAL	RLD	2011-06-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N202080-002	OXAYDO	7.5MG	TABLET / ORAL	RLD	2011-06-17	`bb7c543d1eb4…`

Observed Orange Book patent history#

Patent history page 1 of 9 · 340 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202080-001	7201920	2025-03-16	Drug product	2011-07-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202080-002	7201920	2025-03-16	Drug product	2011-07-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202080-001	7201920	2025-03-16	Drug product	2011-07-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202080-002	7201920	2025-03-16	Drug product	2011-07-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202080-001	7201920	2025-03-16	Drug product	2011-07-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202080-002	7201920	2025-03-16	Drug product	2011-07-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202080-001	7201920	2025-03-16	Drug product	2011-07-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202080-002	7201920	2025-03-16	Drug product	2011-07-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202080-001	9492443	2024-05-26	Drug product	2016-11-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202080-001	7201920	2025-03-16	Drug product	2011-07-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202080-002	9492443	2024-05-26	Drug product	2016-11-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202080-002	7201920	2025-03-16	Drug product	2011-07-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202080-001	9492443	2024-05-26	Drug product	2016-11-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202080-001	7201920	2025-03-16	Drug product	2011-07-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202080-002	9492443	2024-05-26	Drug product	2016-11-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202080-002	7201920	2025-03-16	Drug product	2011-07-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202080-001	9492443	2024-05-26	Drug product	2016-11-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202080-001	7201920	2025-03-16	Drug product	2011-07-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202080-002	9492443	2024-05-26	Drug product	2016-11-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202080-002	7201920	2025-03-16	Drug product	2011-07-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202080-001	9492443	2024-05-26	Drug product	2016-11-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202080-001	7201920	2025-03-16	Drug product	2011-07-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202080-002	9492443	2024-05-26	Drug product	2016-11-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202080-002	7201920	2025-03-16	Drug product	2011-07-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202080-001	9492443	2024-05-26	Drug product	2016-11-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202080-001	7201920	2025-03-16	Drug product	2011-07-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202080-002	9492443	2024-05-26	Drug product	2016-11-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202080-002	7201920	2025-03-16	Drug product	2011-07-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202080-001	9492443	2024-05-26	Drug product	2016-11-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202080-001	7201920	2025-03-16	Drug product	2011-07-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202080-002	9492443	2024-05-26	Drug product	2016-11-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202080-002	7201920	2025-03-16	Drug product	2011-07-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202080-001	9492443	2024-05-26	Drug product	2016-11-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202080-001	7201920	2025-03-16	Drug product	2011-07-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202080-002	9492443	2024-05-26	Drug product	2016-11-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202080-002	7201920	2025-03-16	Drug product	2011-07-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202080-001	9492443	2024-05-26	Drug product	2016-11-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202080-001	7201920	2025-03-16	Drug product	2011-07-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202080-002	9492443	2024-05-26	Drug product	2016-11-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202080-002	7201920	2025-03-16	Drug product	2011-07-14	`1e350fbaab3a…`

Additional Listing Data#

Finished product: Yes
Brand name base: OXAYDO
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OXYCODONE HYDROCHLORIDE	7.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
C1ENJ2TE6C	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1049621	Internal RxNorm lookup
1113314	Internal RxNorm lookup
1664448	Internal RxNorm lookup
1664634	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
cff0c64a-63f5-4b3c-909a-cdecf6755cbe	Available on FDA.report

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
69344-213-11	OXAYDO	100 in 1 BOTTLE	TABLET	100		21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69344-213-11	EA - Each	69344-213	b5cbf989-e082-4e94-baba-d11a2d6a5309	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
OXYCODONE HYDROCHLORIDE	ACTIVE INGREDIENT	C1ENJ2TE6C	OXAYDO (OXYCODONE HYDROCHLORIDE) TABLET [EGALET US INC.]	2
OXYCODONE	ACTIVE MOIETY	CD35PMG570	OXAYDO (OXYCODONE HYDROCHLORIDE) TABLET [EGALET US INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69344-213	OXAYDO (OXYCODONE HYDROCHLORIDE) TABLET [ZYLA LIFE SCIENCES US LLC]	19	Current NDC, Legacy NDC, 1 package rows	20240427_cff0c64a-63f5-4b3c-909a-cdecf6755cbe.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OXAYDO	OXYCODONE HYDROCHLORIDE	Zyla Life Sciences US LLC	cff0c64a-63f5-4b3c-909a-cdecf6755cbe	2026-01-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 202080 application number: NDA202080 ndc (product): 69344-213

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
1664448	Oxaydo 5 MG Oral Tablet	PSN	cff0c64a-63f5-4b3c-909a-cdecf6755cbe	21
1664634	Oxaydo 7.5 MG Oral Tablet	PSN	cff0c64a-63f5-4b3c-909a-cdecf6755cbe	21
1049621	oxyCODONE HCl 5 MG Oral Tablet	PSN	cff0c64a-63f5-4b3c-909a-cdecf6755cbe	21
1113314	oxyCODONE HCl 7.5 MG Oral Tablet	PSN	cff0c64a-63f5-4b3c-909a-cdecf6755cbe	21
1664448	oxycodone hydrochloride 5 MG Oral Tablet [Oxaydo]	SBD	cff0c64a-63f5-4b3c-909a-cdecf6755cbe	21
1664634	oxycodone hydrochloride 7.5 MG Oral Tablet [Oxaydo]	SBD	cff0c64a-63f5-4b3c-909a-cdecf6755cbe	21
1049621	oxycodone hydrochloride 5 MG Oral Tablet	SCD	cff0c64a-63f5-4b3c-909a-cdecf6755cbe	21
1113314	oxycodone hydrochloride 7.5 MG Oral Tablet	SCD	cff0c64a-63f5-4b3c-909a-cdecf6755cbe	21
1664448	Oxaydo 5 MG Oral Tablet	SY	cff0c64a-63f5-4b3c-909a-cdecf6755cbe	21
1664634	Oxaydo 7.5 MG Oral Tablet	SY	cff0c64a-63f5-4b3c-909a-cdecf6755cbe	21

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69344-213-11	69344021311	100 TABLET in 1 BOTTLE (69344-213-11)	100 tablet	2015-09-01	0000-00-00	No	No	Current