Oxycodone and Aspirin

Product NDC: 42806-061
11-digit product format: 428060061
Labeler code: 42806
Product ID: 42806-061_8cd322df-f304-482e-9ed5-a7afa26f5645
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oxycodone and Aspirin
Dosage form: TABLET
Route: ORAL
Labeler: Epic Pharma, LLC
Application: ANDA040910
Marketing category: ANDA
Marketing start: 2020-06-30
Substance: ASPIRIN; OXYCODONE HYDROCHLORIDE
Active strength: 325; 4.8355 mg/1; mg/1
Pharmacologic classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Full Opioid Agonists [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Opioid Agonist [EPC], Platelet Aggregation Inhibitor [EPC]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
A040910-001	OXYCODONE AND ASPIRIN	ASPIRIN; OXYCODONE HYDROCHLORIDE	325MG;4.8355MG	TABLET / ORAL			2020-07-16

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.

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	A040910-001	OXYCODONE AND ASPIRIN	325MG;4.8355MG	TABLET / ORAL	AA	2020-07-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040910-001	OXYCODONE AND ASPIRIN	325MG;4.8355MG	TABLET / ORAL	AA	2020-07-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040910-001	OXYCODONE AND ASPIRIN	325MG;4.8355MG	TABLET / ORAL	AA	2020-07-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040910-001	OXYCODONE AND ASPIRIN	325MG;4.8355MG	TABLET / ORAL	AA	2020-07-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040910-001	OXYCODONE AND ASPIRIN	325MG;4.8355MG	TABLET / ORAL	AA	2020-07-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040910-001	OXYCODONE AND ASPIRIN	325MG;4.8355MG	TABLET / ORAL	AA	2020-07-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040910-001	OXYCODONE AND ASPIRIN	325MG;4.8355MG	TABLET / ORAL	AA	2020-07-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040910-001	OXYCODONE AND ASPIRIN	325MG;4.8355MG	TABLET / ORAL	AA	2020-07-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040910-001	OXYCODONE AND ASPIRIN	325MG;4.8355MG	TABLET / ORAL	AA	2020-07-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040910-001	OXYCODONE AND ASPIRIN	325MG;4.8355MG	TABLET / ORAL	AA	2020-07-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040910-001	OXYCODONE AND ASPIRIN	325MG;4.8355MG	TABLET / ORAL	AA	2020-07-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040910-001	OXYCODONE AND ASPIRIN	325MG;4.8355MG	TABLET / ORAL	AA	2020-07-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040910-001	OXYCODONE AND ASPIRIN	325MG;4.8355MG	TABLET / ORAL	AA	2020-07-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040910-001	OXYCODONE AND ASPIRIN	325MG;4.8355MG	TABLET / ORAL	AA	2020-07-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040910-001	OXYCODONE AND ASPIRIN	325MG;4.8355MG	TABLET / ORAL	AA	2020-07-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040910-001	OXYCODONE AND ASPIRIN	325MG;4.8355MG	TABLET / ORAL	AA	2020-07-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040910-001	OXYCODONE AND ASPIRIN	325MG;4.8355MG	TABLET / ORAL	AA	2020-07-16	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A040910-001	OXYCODONE AND ASPIRIN	325MG;4.8355MG	TABLET / ORAL	AA	2020-07-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040910-001	OXYCODONE AND ASPIRIN	325MG;4.8355MG	TABLET / ORAL	AA	2020-07-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040910-001	OXYCODONE AND ASPIRIN	325MG;4.8355MG	TABLET / ORAL	AA	2020-07-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040910-001	OXYCODONE AND ASPIRIN	325MG;4.8355MG	TABLET / ORAL	AA	2020-07-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040910-001	OXYCODONE AND ASPIRIN	325MG;4.8355MG	TABLET / ORAL	AA	2020-07-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040910-001	OXYCODONE AND ASPIRIN	325MG;4.8355MG	TABLET / ORAL	AA	2020-07-16	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040910-001	OXYCODONE AND ASPIRIN	325MG;4.8355MG	TABLET / ORAL	AA	2020-07-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040910-001	OXYCODONE AND ASPIRIN	325MG;4.8355MG	TABLET / ORAL	AA	2020-07-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040910-001	OXYCODONE AND ASPIRIN	325MG;4.8355MG	TABLET / ORAL	AA	2020-07-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040910-001	OXYCODONE AND ASPIRIN	325MG;4.8355MG	TABLET / ORAL	AA	2020-07-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040910-001	OXYCODONE AND ASPIRIN	325MG;4.8355MG	TABLET / ORAL	AA	2020-07-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040910-001	OXYCODONE AND ASPIRIN	325MG;4.8355MG	TABLET / ORAL	AA	2020-07-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040910-001	OXYCODONE AND ASPIRIN	325MG;4.8355MG	TABLET / ORAL	AA	2020-07-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040910-001	OXYCODONE AND ASPIRIN	325MG;4.8355MG	TABLET / ORAL	AA	2020-07-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040910-001	OXYCODONE AND ASPIRIN	325MG;4.8355MG	TABLET / ORAL	AA	2020-07-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040910-001	OXYCODONE AND ASPIRIN	325MG;4.8355MG	TABLET / ORAL	AA	2020-07-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040910-001	OXYCODONE AND ASPIRIN	325MG;4.8355MG	TABLET / ORAL	AA	2020-07-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040910-001	OXYCODONE AND ASPIRIN	325MG;4.8355MG	TABLET / ORAL	AA	2020-07-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040910-001	OXYCODONE AND ASPIRIN	325MG;4.8355MG	TABLET / ORAL	AA	2020-07-16	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A040910-001	OXYCODONE AND ASPIRIN	325MG;4.8355MG	TABLET / ORAL		2020-07-16	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040910-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040910-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040910-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040910-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040910-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040910-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040910-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040910-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040910-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040910-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040910-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040910-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040910-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040910-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040910-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040910-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040910-001	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A040910-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040910-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040910-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040910-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040910-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040910-001	AA	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040910-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040910-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040910-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040910-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040910-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040910-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040910-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040910-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040910-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040910-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040910-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040910-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040910-001	AA	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Oxycodone and Aspirin
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OXYCODONE HYDROCHLORIDE	325 mg/1
ASPIRIN	4.8355 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
C1ENJ2TE6C	Internal UNII lookup
R16CO5Y76E	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
848768	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
3292a7c6-5ba3-4563-bc62-e43040634123	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
d7724692-1155-4cc8-a415-22f5fc4aec35	Product name	6	20220216
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
f212291f-05fe-9603-fc7e-bd73e38ce1e6	Product name	2	20161129
ade821ba-260a-47e2-bd89-743e27ac9906	Product name	1	20161121
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
182f9ab4-4ab5-c449-200f-87ce2ce8e550	Product name	2	20151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657	Product name	1	20150929
8a245632-e24f-4ccc-b671-995d89c96ebc	Product name	1	20141203
23475c0b-a5b5-4fec-b97f-acca901eae6a	Product name	1	20140718
2a21311a-89e2-0e83-2ebd-117f9798b2b2	Product name	1	20140508
7b2938c9-7eb7-e312-ae90-f54f4240361e	Product name	1	20140508
7fa873c5-fb27-7119-0a05-634ad477dea7	Product name	1	20140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94e	Product name	1	20140508
96c2be53-8e44-452d-56a2-d255b2f1af2d	Product name	1	20140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44	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
42806-061-01	Oxycodone and Aspirin	100 in 1 BOTTLE	TABLET	100		9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42806-061	OXYCODONE AND ASPIRIN TABLET [EPIC PHARMA, LLC]	1	Current NDC, 1 package rows	20230919_3292a7c6-5ba3-4563-bc62-e43040634123.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
Oxycodone and Aspirin	OXYCODONE AND ASPIRIN	Epic Pharma, LLC	3292a7c6-5ba3-4563-bc62-e43040634123	2025-12-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040910 application number: ANDA040910 ndc (product): 42806-061

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
R16CO5Y76E	ASPIRIN	50-78-2	ASPIRIN
C1ENJ2TE6C	OXYCODONE HYDROCHLORIDE	124-90-3	OXYCODONE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
848768	oxyCODONE 4.8355 MG / aspirin 325 MG Oral Tablet	PSN	3292a7c6-5ba3-4563-bc62-e43040634123	9
848768	aspirin 325 MG / oxycodone hydrochloride 4.84 MG Oral Tablet	SCD	3292a7c6-5ba3-4563-bc62-e43040634123	9
848768	ASA 325 MG / oxycodone hydrochloride 4.8355 MG Oral Tablet	SY	3292a7c6-5ba3-4563-bc62-e43040634123	9
848768	ASA 325 MG / oxycodone hydrochloride 4.84 MG Oral Tablet	SY	3292a7c6-5ba3-4563-bc62-e43040634123	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
42806-061-01	42806006101	100 TABLET in 1 BOTTLE (42806-061-01)	100 tablet	2020-06-30	No	No	Current