oxycodone and acetaminophen

Product NDC: 57664-155
11-digit product format: 576640155
Labeler code: 57664
Product ID: 57664-155_8df48502-9503-4e53-b637-23f035271bf5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: oxycodone and acetaminophen
Dosage form: TABLET
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA090535
Marketing category: ANDA
Marketing start: 2015-11-02
Marketing end: 0000-00-00
Substance: OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN
Active strength: 5 mg/1; mg/1
Pharmacologic classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	57664-155		D	Discontinued by firm	2026-10-05
excluded package	package	57664-155	57664-155-13	D	Discontinued by firm	2026-10-05
excluded package	package	57664-155	57664-155-88	D	Discontinued by firm	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 · 36 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	57664-155-88	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	57664-155-13	`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	57664-155-88	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	57664-155-13	`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	57664-155-88	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	57664-155-13	`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	57664-155-88	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	57664-155-13	`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	57664-155-88	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	57664-155-13	`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	57664-155-88	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	57664-155-13	`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	57664-155-88	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	57664-155-13	`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	57664-155-88	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	57664-155-13	`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	57664-155-88	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	57664-155-13	`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	57664-155-88	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	57664-155-13	`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	57664-155-88	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	57664-155-13	`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	57664-155-88	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	57664-155-13	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A090535-001	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;2.5MG	TABLET / ORAL	2013-12-26
A090535-002	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;5MG	TABLET / ORAL	2013-12-26
A090535-003	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;7.5MG	TABLET / ORAL	2013-12-26
A090535-004	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;10MG	TABLET / ORAL	2013-12-26

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 5 · 172 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	A090535-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	2013-12-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090535-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2013-12-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090535-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2013-12-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090535-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2013-12-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090535-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	2013-12-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090535-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2013-12-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090535-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2013-12-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090535-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2013-12-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090535-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	2013-12-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090535-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2013-12-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090535-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2013-12-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090535-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2013-12-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090535-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	2013-12-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090535-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2013-12-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090535-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2013-12-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090535-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2013-12-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090535-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	2013-12-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090535-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2013-12-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090535-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2013-12-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090535-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2013-12-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090535-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	2013-12-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090535-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2013-12-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090535-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2013-12-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090535-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2013-12-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090535-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	2013-12-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090535-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2013-12-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090535-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2013-12-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090535-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2013-12-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090535-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	2013-12-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090535-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2013-12-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090535-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2013-12-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090535-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2013-12-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090535-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	2013-12-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090535-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2013-12-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090535-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2013-12-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090535-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2013-12-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090535-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	2013-12-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090535-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2013-12-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090535-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2013-12-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090535-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2013-12-26	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 96 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090535-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090535-002	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090535-003	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090535-004	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090535-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090535-002	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090535-003	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090535-004	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090535-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090535-002	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090535-003	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090535-004	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090535-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090535-002	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090535-003	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090535-004	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090535-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090535-002	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090535-003	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090535-004	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090535-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090535-002	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090535-003	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090535-004	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090535-001	AA	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090535-002	AA	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090535-003	AA	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090535-004	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090535-001	AA	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090535-002	AA	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090535-003	AA	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090535-004	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090535-001	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090535-002	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090535-003	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090535-004	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090535-001	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A090535-002	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A090535-003	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A090535-004	AA	1	`c0c555d07b60…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
57664-155-13	2020-09-14	Oxycodone and Acetaminophen Tablets, USP CII
57664-155-88	2020-09-14	Oxycodone and Acetaminophen Tablets, USP CII
57664-155-13	2020-07-22	Oxycodone and Acetaminophen Tablets, USP CII
57664-155-88	2020-07-22	Oxycodone and Acetaminophen Tablets, USP CII

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57664-155-13	EA - Each	57664-155	d336c946-5ae2-4ce1-b3ac-8db164c57a92	1	2016-07-19
57664-155-88	EA - Each	57664-155	cde506fc-cdea-43dc-b6e9-fe66d420b5c7	1	2016-07-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Acetaminophen	ACTIVE INGREDIENT	362O9ITL9D	OXYCODONE AND ACETAMINOPHEN TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]	3
Oxycodone hydrochloride	ACTIVE INGREDIENT	C1ENJ2TE6C	OXYCODONE AND ACETAMINOPHEN TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]	3
Acetaminophen	ACTIVE MOIETY	362O9ITL9D	OXYCODONE AND ACETAMINOPHEN TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]	3
Oxycodone	ACTIVE MOIETY	CD35PMG570	OXYCODONE AND ACETAMINOPHEN TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	OXYCODONE AND ACETAMINOPHEN TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	OXYCODONE AND ACETAMINOPHEN TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]	3
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	OXYCODONE AND ACETAMINOPHEN TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]	3
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	OXYCODONE AND ACETAMINOPHEN TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	OXYCODONE AND ACETAMINOPHEN TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	OXYCODONE AND ACETAMINOPHEN TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]	3
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	OXYCODONE AND ACETAMINOPHEN TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]	3

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
C1ENJ2TE6C	OXYCODONE HYDROCHLORIDE	124-90-3	OXYCODONE HYDROCHLORIDE
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1049221	oxyCODONE 5 MG / acetaminophen 325 MG Oral Tablet	PSN	888bdb1b-4061-09e2-e053-2995a90a2423	2
1049221	acetaminophen 325 MG / oxycodone hydrochloride 5 MG Oral Tablet	SCD	888bdb1b-4061-09e2-e053-2995a90a2423	2
1049221	APAP 325 MG / oxycodone hydrochloride 5 MG Oral Tablet	SY	888bdb1b-4061-09e2-e053-2995a90a2423	2

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Oxy/Apap 5/325	RedPharm Drug, Inc.	2021-01-13	HUMAN PRESCRIPTION DRUG LABEL	2
Oxycodone and Acetaminophen Tablets, USP CII	Lake Erie Medical DBA Quality Care Products LLC	2019-11-01	HUMAN PRESCRIPTION DRUG LABEL	6
Oxycodone and Acetaminophen Tablets, USP CII	Sun Pharmaceutical Industries, Inc.	2018-08-07	HUMAN PRESCRIPTION DRUG LABEL	12