Oxycodone/APAP

Product NDC: 61919-835
11-digit product format: 619190835
Labeler code: 61919
Product ID: 61919-835_94e52165-e8d7-a353-e053-2995a90ab296
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oxycodone/APAP
Dosage form: TABLET
Route: ORAL
Labeler: Direct_Rx
Application: ANDA207419
Marketing category: ANDA
Marketing start: 2019-06-26
Marketing end: 0000-00-00
Substance: OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN
Active strength: 8 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	61919-835		I	Inactivated by FDA	2026-09-09
excluded package	package	61919-835	61919-835-30	I	Inactivated by FDA	2026-09-09
excluded package	package	61919-835	61919-835-60	I	Inactivated by FDA	2026-09-09

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 · 45 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	61919-835-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-835-30	`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	61919-835-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-835-30	`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	61919-835-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-835-30	`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	61919-835-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-835-30	`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	61919-835-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-835-30	`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	61919-835-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-835-30	`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	61919-835-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-835-30	`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	61919-835-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-835-30	`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	61919-835-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-835-30	`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	61919-835-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61919-835-30	`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	61919-835-60	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61919-835-30	`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	61919-835-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61919-835-30	`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	61919-835-60	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	61919-835-30	`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	61919-835-60	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	61919-835-30	`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	61919-835-60	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	61919-835-30	`1332a3947898…`	`d4bfe170f9cd…`

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	TE codes	Approval date
A207419-001	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;2.5MG	TABLET / ORAL	AA	2017-03-22
A207419-002	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;5MG	TABLET / ORAL	AA	2017-03-22
A207419-003	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;7.5MG	TABLET / ORAL	AA	2017-03-22
A207419-004	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;10MG	TABLET / ORAL	AA	2017-03-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A207419-001	AA
A207419-002	AA
A207419-003	AA
A207419-004	AA

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	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A207419-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2017-03-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207419-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2017-03-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207419-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2017-03-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207419-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2017-03-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207419-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2017-03-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207419-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2017-03-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207419-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2017-03-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207419-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2017-03-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207419-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2017-03-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207419-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2017-03-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207419-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2017-03-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207419-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2017-03-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207419-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2017-03-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207419-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2017-03-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207419-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2017-03-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207419-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2017-03-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207419-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2017-03-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207419-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2017-03-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207419-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2017-03-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207419-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2017-03-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207419-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2017-03-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207419-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2017-03-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207419-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2017-03-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207419-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2017-03-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207419-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2017-03-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207419-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2017-03-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207419-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2017-03-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207419-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2017-03-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207419-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2017-03-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207419-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2017-03-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207419-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2017-03-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207419-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2017-03-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207419-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2017-03-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207419-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2017-03-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207419-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2017-03-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207419-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2017-03-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207419-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2017-03-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207419-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2017-03-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207419-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2017-03-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207419-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2017-03-22	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A207419-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207419-002	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207419-003	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207419-004	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207419-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207419-002	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207419-003	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207419-004	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207419-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207419-002	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207419-003	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207419-004	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207419-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207419-002	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207419-003	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207419-004	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207419-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207419-002	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207419-003	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207419-004	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207419-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207419-002	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207419-003	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207419-004	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207419-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207419-002	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207419-003	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207419-004	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207419-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207419-002	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207419-003	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207419-004	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207419-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207419-002	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207419-003	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207419-004	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207419-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207419-002	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207419-003	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207419-004	AA	1	`d8e5a09893c0…`

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
61919-835-30	Oxycodone/APAP	30 in 1 BOTTLE	TABLET	30		2
61919-835-60	Oxycodone/APAP	60 in 1 BOTTLE	TABLET	60		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-835-30	EA - Each	61919-835	486c28ec-6132-47c4-9170-f263f458a4ae	1	2019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-835	OXYCODONE/APAP TABLET [DIRECT_RX]	2	Legacy NDC, 2 package rows	20191015_8c3b715b-4552-fb38-e053-2995a90a3d42.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 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OXYCODONE AND ACETAMINOPHEN	OXYCODONE AND ACETAMINOPHEN	Camber Pharmaceuticals, Inc.	42777191-0454-4ccb-8fc3-8b18b0ee43f7	2025-08-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207419 application number: ANDA207419
OXYCODONE AND ACETAMINOPHEN	OXYCODONE AND ACETAMINOPHEN	Direct_Rx	90a11364-fc42-e94e-e053-2a95a90a9782	2025-07-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207419 application number: ANDA207419
OXYCODONE AND ACETAMINOPHEN	OXYCODONE AND ACETAMINOPHEN	Asclemed USA, Inc.	71c7a627-6ed9-4f49-8cdc-b3228c021e64	2025-04-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207419 application number: ANDA207419
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Direct_Rx	e4e27022-581e-ba8c-e053-2a95a90a1ae4	2025-04-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207419 application number: ANDA207419
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	NuCare Pharmaceuticals,Inc.	9e4024f4-0f60-dfef-e053-2995a90ac366	2024-06-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207419 application number: ANDA207419
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	NuCare Pharmaceuticals,Inc.	925f9787-3d1c-0189-e053-2a95a90a2972	2024-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207419 application number: ANDA207419
OXYCODONE AND ACETAMINOPHEN	OXYCODONE AND ACETAMINOPHEN	Bryant Ranch Prepack	4a873428-bb5a-4e48-9185-2a27f289110d	2024-05-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207419 application number: ANDA207419
OXYCODONE AND ACETAMINOPHEN	OXYCODONE AND ACETAMINOPHEN	Bryant Ranch Prepack	88d05136-7b04-4b25-af1c-6bc72fdbcbd7	2024-05-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207419 application number: ANDA207419
OXYCODONE AND ACETAMINOPHEN	OXYCODONE AND ACETAMINOPHEN	Bryant Ranch Prepack	96173ce4-4836-43ae-9797-5246f830643a	2024-05-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207419 application number: ANDA207419
OXYCODONE AND ACETAMINOPHEN	OXYCODONE AND ACETAMINOPHEN	Bryant Ranch Prepack	3791abd3-fcdf-4c8d-b46d-db6e5c805770	2024-05-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207419 application number: ANDA207419
OXYCODONE AND ACETAMINOPHEN	OXYCODONE AND ACETAMINOPHEN	Bryant Ranch Prepack	0c85d1b8-ea42-421d-a305-4d338b47150f	2024-05-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207419 application number: ANDA207419
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Bryant Ranch Prepack	4da8a7bd-0d2e-452c-afb5-fed4e230a9bd	2024-04-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207419 application number: ANDA207419
OXYCODONE AND ACETAMINOPHEN	OXYCODONE AND ACETAMINOPHEN	XLCare Pharmaceuticals, Inc.	7f3c6dd7-6bc8-450e-aded-997f9cf63a8f	2024-02-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207419 application number: ANDA207419
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Proficient Rx LP	78933d4a-d78a-43bc-9052-a032901ee050	2022-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207419 application number: ANDA207419
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Proficient Rx LP	5df7c033-0f31-45bc-8c34-3da45635e66d	2022-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207419 application number: ANDA207419
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Proficient Rx LP	484a4323-0758-439d-844f-f04d7e5ef6f3	2022-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207419 application number: ANDA207419
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Camber Pharmaceuticals, Inc.	2a49ee34-6f1d-4ed3-8daa-343723d2a2be	2018-02-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207419 application number: ANDA207419

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
1049225	oxyCODONE 7.5 MG / acetaminophen 325 MG Oral Tablet	PSN	8c3b715b-4552-fb38-e053-2995a90a3d42	2
1049225	acetaminophen 325 MG / oxycodone hydrochloride 7.5 MG Oral Tablet	SCD	8c3b715b-4552-fb38-e053-2995a90a3d42	2
1049225	APAP 325 MG / oxycodone hydrochloride 7.5 MG Oral Tablet	SY	8c3b715b-4552-fb38-e053-2995a90a3d42	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-835-30	61919083530	30 TABLET in 1 BOTTLE (61919-835-30)	30 tablet	2019-06-26	0000-00-00	No	No	Current
61919-835-60	61919083560	60 TABLET in 1 BOTTLE (61919-835-60)	60 tablet	2019-06-26	0000-00-00	No	No	Current