Oxycodone and Acetaminophen

Product NDC: 70710-1328
11-digit product format: 707101328
Labeler code: 70710
Product ID: 70710-1328_d0b7fd0e-5231-4f72-920f-e78d3a96335e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oxycodone and Acetaminophen
Dosage form: TABLET
Route: ORAL
Labeler: Zydus Pharmaceuticals (USA) Inc.
Application: ANDA210079
Marketing category: ANDA
Marketing start: 2017-12-28
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: 2022-12-31
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	70710-1328		I	Inactivated by FDA	2026-08-17
excluded package	package	70710-1328	70710-1328-1	I	Inactivated by FDA	2026-08-17
excluded package	package	70710-1328	70710-1328-5	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 · 48 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	70710-1328-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70710-1328-5	`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	70710-1328-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70710-1328-5	`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	70710-1328-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70710-1328-5	`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	70710-1328-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70710-1328-5	`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	70710-1328-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70710-1328-5	`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	70710-1328-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70710-1328-5	`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	70710-1328-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70710-1328-5	`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	70710-1328-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70710-1328-5	`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	70710-1328-1	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70710-1328-5	`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	70710-1328-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70710-1328-5	`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	70710-1328-1	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70710-1328-5	`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	70710-1328-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70710-1328-5	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	70710-1328-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	70710-1328-5	`8af77b9d5b6f…`	`d9bbb34c5368…`
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	70710-1328-1	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	70710-1328-5	`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	70710-1328-1	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	70710-1328-5	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	70710-1328-1	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	70710-1328-5	`fb8cb913e6d1…`	`eb8c232b6be0…`

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

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
A210079-001	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;2.5MG	TABLET / ORAL	2017-12-28
A210079-002	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;5MG	TABLET / ORAL	2017-12-28
A210079-003	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;7.5MG	TABLET / ORAL	2017-12-28
A210079-004	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;10MG	TABLET / ORAL	2017-12-28

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 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A210079-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	2017-12-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210079-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2017-12-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210079-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2017-12-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210079-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2017-12-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210079-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	2017-12-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210079-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2017-12-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210079-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2017-12-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210079-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2017-12-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210079-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	2017-12-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210079-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2017-12-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210079-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2017-12-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210079-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2017-12-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210079-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	2017-12-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210079-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2017-12-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210079-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2017-12-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210079-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2017-12-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210079-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	2017-12-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210079-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2017-12-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210079-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2017-12-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210079-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2017-12-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210079-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	2017-12-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210079-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2017-12-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210079-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2017-12-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210079-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2017-12-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210079-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	2017-12-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210079-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2017-12-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210079-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2017-12-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210079-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2017-12-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210079-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	2017-12-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210079-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2017-12-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210079-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2017-12-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210079-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2017-12-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210079-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	2017-12-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210079-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2017-12-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210079-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2017-12-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210079-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2017-12-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210079-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	2017-12-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210079-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	2017-12-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210079-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	2017-12-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210079-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	2017-12-28	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 52 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	A210079-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210079-002	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210079-003	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210079-004	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210079-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210079-002	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210079-003	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210079-004	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210079-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210079-002	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210079-003	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210079-004	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210079-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210079-002	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210079-003	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210079-004	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210079-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210079-002	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210079-003	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210079-004	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210079-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210079-002	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210079-003	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210079-004	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210079-001	AA	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210079-002	AA	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210079-003	AA	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210079-004	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210079-001	AA	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A210079-002	AA	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A210079-003	AA	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A210079-004	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210079-001	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A210079-002	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A210079-003	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A210079-004	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210079-001	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A210079-002	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A210079-003	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A210079-004	AA	1	`c0c555d07b60…`

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
70710-1328-1	2022-07-29	C162847	48780-1	e4f33bdf-a7f0-d8a0-e053-dadaa90a6e4e	Oxycodone and Acetaminophen Tablets, USP CII Revised: August 2020
70710-1328-5	2022-07-29	C162847	48780-1	e4f33bdf-a7f0-d8a0-e053-dadaa90a6e4e	Oxycodone and Acetaminophen Tablets, USP CII Revised: August 2020

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70710-1328-1	Oxycodone and Acetaminophen	100 in 1 BOTTLE	TABLET	100		8
70710-1328-5	Oxycodone and Acetaminophen	500 in 1 BOTTLE	TABLET	500		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70710-1328	OXYCODONE AND ACETAMINOPHEN TABLET [ZYDUS PHARMACEUTICALS (USA) INC. ]	8	Legacy NDC, 2 package rows	20210113_c50617ea-66b6-43be-b579-b9a3836b73a2.zip

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
1049214	oxyCODONE 10 MG / acetaminophen 325 MG Oral Tablet	PSN	c50617ea-66b6-43be-b579-b9a3836b73a2	8
1049221	oxyCODONE 5 MG / acetaminophen 325 MG Oral Tablet	PSN	c50617ea-66b6-43be-b579-b9a3836b73a2	8
1049225	oxyCODONE 7.5 MG / acetaminophen 325 MG Oral Tablet	PSN	c50617ea-66b6-43be-b579-b9a3836b73a2	8
1049635	oxyCODONE HCl 2.5 MG / acetaminophen 325 MG Oral Tablet	PSN	c50617ea-66b6-43be-b579-b9a3836b73a2	8
1049214	acetaminophen 325 MG / oxycodone hydrochloride 10 MG Oral Tablet	SCD	c50617ea-66b6-43be-b579-b9a3836b73a2	8
1049635	acetaminophen 325 MG / oxycodone hydrochloride 2.5 MG Oral Tablet	SCD	c50617ea-66b6-43be-b579-b9a3836b73a2	8
1049221	acetaminophen 325 MG / oxycodone hydrochloride 5 MG Oral Tablet	SCD	c50617ea-66b6-43be-b579-b9a3836b73a2	8
1049225	acetaminophen 325 MG / oxycodone hydrochloride 7.5 MG Oral Tablet	SCD	c50617ea-66b6-43be-b579-b9a3836b73a2	8
1049214	APAP 325 MG / oxycodone hydrochloride 10 MG Oral Tablet	SY	c50617ea-66b6-43be-b579-b9a3836b73a2	8
1049635	APAP 325 MG / Oxycodone Hydrochloride 2.5 MG Oral Tablet	SY	c50617ea-66b6-43be-b579-b9a3836b73a2	8
1049221	APAP 325 MG / oxycodone hydrochloride 5 MG Oral Tablet	SY	c50617ea-66b6-43be-b579-b9a3836b73a2	8
1049225	APAP 325 MG / oxycodone hydrochloride 7.5 MG Oral Tablet	SY	c50617ea-66b6-43be-b579-b9a3836b73a2	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70710-1328-1	70710132801	100 TABLET in 1 BOTTLE (70710-1328-1)	100 tablet	2017-12-28	0000-00-00	No	No	Current
70710-1328-5	70710132805	500 TABLET in 1 BOTTLE (70710-1328-5)	500 tablet	2017-12-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Oxycodone and Acetaminophen Tablets, USP CII Revised: August 2020	Zydus Pharmaceuticals (USA) Inc. \| Nesher Pharmaceuticals (USA) LLC	2020-08-18	HUMAN PRESCRIPTION DRUG LABEL	8