Oxycodone and Acetaminophen

Product NDC: 55700-498
11-digit product format: 557000498
Labeler code: 55700
Product ID: 55700-498_8c9196fe-65e3-4e1f-b71b-ae9e08d5a4e7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oxycodone and Acetaminophen
Dosage form: TABLET
Route: ORAL
Labeler: Quality Care Products LLC
Application: ANDA201972
Marketing category: ANDA
Marketing start: 2016-12-01
Marketing end: 0000-00-00
Substance: ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Active strength: 325 mg/1; mg/1
Pharmacologic classes: Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 15 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	55700-498		D	Discontinued by firm	2026-08-03
excluded package	package	55700-498	55700-498-01	D	Discontinued by firm	2026-08-03
excluded package	package	55700-498	55700-498-05	D	Discontinued by firm	2026-08-03
excluded package	package	55700-498	55700-498-10	D	Discontinued by firm	2026-08-03
excluded package	package	55700-498	55700-498-14	D	Discontinued by firm	2026-08-03
excluded package	package	55700-498	55700-498-15	D	Discontinued by firm	2026-08-03
excluded package	package	55700-498	55700-498-20	D	Discontinued by firm	2026-08-03
excluded package	package	55700-498	55700-498-21	D	Discontinued by firm	2026-08-03
excluded package	package	55700-498	55700-498-24	D	Discontinued by firm	2026-08-03
excluded package	package	55700-498	55700-498-28	D	Discontinued by firm	2026-08-03
excluded package	package	55700-498	55700-498-30	D	Discontinued by firm	2026-08-03
excluded package	package	55700-498	55700-498-40	D	Discontinued by firm	2026-08-03
excluded package	package	55700-498	55700-498-56	D	Discontinued by firm	2026-08-03
excluded package	package	55700-498	55700-498-60	D	Discontinued by firm	2026-08-03
excluded package	package	55700-498	55700-498-90	D	Discontinued by firm	2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 47 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product	55700-498		D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55700-498	55700-498-60	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55700-498	55700-498-15	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55700-498	55700-498-10	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55700-498	55700-498-56	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55700-498	55700-498-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55700-498	55700-498-90	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55700-498	55700-498-28	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55700-498	55700-498-14	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55700-498	55700-498-30	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55700-498	55700-498-21	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55700-498	55700-498-05	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55700-498	55700-498-40	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55700-498	55700-498-20	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55700-498	55700-498-24	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	55700-498		D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55700-498	55700-498-60	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55700-498	55700-498-15	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55700-498	55700-498-10	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55700-498	55700-498-56	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55700-498	55700-498-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55700-498	55700-498-90	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55700-498	55700-498-28	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55700-498	55700-498-14	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55700-498	55700-498-30	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55700-498	55700-498-21	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55700-498	55700-498-05	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55700-498	55700-498-40	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55700-498	55700-498-20	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55700-498	55700-498-24	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55700-498	55700-498-20	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55700-498	55700-498-20	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55700-498	55700-498-20	D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product	55700-498		I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	55700-498	55700-498-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	55700-498	55700-498-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	55700-498	55700-498-24	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	55700-498	55700-498-56	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	55700-498	55700-498-28	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	55700-498	55700-498-14	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	55700-498	55700-498-15	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	55700-498	55700-498-21	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	55700-498	55700-498-05	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	55700-498	55700-498-10	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	55700-498	55700-498-40	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	55700-498	55700-498-90	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	55700-498	55700-498-01	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A201972-001	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;2.5MG	TABLET / ORAL	AA	2013-07-15
A201972-002	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;5MG	TABLET / ORAL	AA	2013-07-15
A201972-003	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;7.5MG	TABLET / ORAL	AA	2013-07-15
A201972-004	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;10MG	TABLET / ORAL	AA	2013-07-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201972-001	AA
A201972-002	AA
A201972-003	AA
A201972-004	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 · 164 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
2026-02-19 14:30 UTC	2026-02	A201972-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2013-07-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201972-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2013-07-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201972-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2013-07-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201972-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2013-07-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201972-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2013-07-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201972-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2013-07-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201972-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2013-07-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201972-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2013-07-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201972-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2013-07-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201972-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2013-07-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201972-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2013-07-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201972-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2013-07-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201972-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2013-07-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201972-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2013-07-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201972-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2013-07-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201972-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2013-07-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201972-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2013-07-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201972-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2013-07-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201972-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2013-07-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201972-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2013-07-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201972-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2013-07-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201972-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2013-07-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201972-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2013-07-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201972-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2013-07-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201972-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2013-07-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201972-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2013-07-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201972-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2013-07-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201972-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2013-07-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201972-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2013-07-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201972-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2013-07-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201972-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2013-07-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201972-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2013-07-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201972-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2013-07-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201972-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2013-07-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201972-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2013-07-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201972-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2013-07-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201972-001	OXYCODONE AND ACETAMINOPHEN	325MG;2.5MG	TABLET / ORAL	AA	2013-07-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201972-002	OXYCODONE AND ACETAMINOPHEN	325MG;5MG	TABLET / ORAL	AA	2013-07-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201972-003	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2013-07-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201972-004	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2013-07-15	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A201972-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201972-002	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201972-003	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201972-004	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201972-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201972-002	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201972-003	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201972-004	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201972-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201972-002	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201972-003	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201972-004	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201972-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201972-002	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201972-003	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201972-004	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201972-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201972-002	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201972-003	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201972-004	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201972-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201972-002	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201972-003	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201972-004	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201972-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201972-002	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201972-003	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201972-004	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201972-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201972-002	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201972-003	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201972-004	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201972-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201972-002	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201972-003	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201972-004	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201972-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201972-002	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201972-003	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201972-004	AA	1	`d06236e962d9…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Aurolife Pharma, LLC	69df20d9-b1d5-47dc-9ff0-29987284f8c7	2025-12-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201972 application number: ANDA201972
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Bryant Ranch Prepack	c12c26be-ba05-4d25-a2bf-f87623c6ae57	2024-08-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201972 application number: ANDA201972
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Proficient Rx LP	dd4dbe5b-8d07-4a96-a78d-2f20da761dad	2019-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201972 application number: ANDA201972
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Proficient Rx LP	df97ea5a-51df-453b-b1b4-edc74c718ee7	2019-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201972 application number: ANDA201972

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55700-498-01	2024-03-14	C162847	48780-1	1030e365-4872-111a-e063-dadaa90a10e2	Oxycodone and Acetaminophen Tablets, USP CII
55700-498-05	2024-03-14	C162847	48780-1	1030e365-4872-111a-e063-dadaa90a10e2	Oxycodone and Acetaminophen Tablets, USP CII
55700-498-10	2024-03-14	C162847	48780-1	1030e365-4872-111a-e063-dadaa90a10e2	Oxycodone and Acetaminophen Tablets, USP CII
55700-498-14	2024-03-14	C162847	48780-1	1030e365-4872-111a-e063-dadaa90a10e2	Oxycodone and Acetaminophen Tablets, USP CII
55700-498-15	2024-03-14	C162847	48780-1	1030e365-4872-111a-e063-dadaa90a10e2	Oxycodone and Acetaminophen Tablets, USP CII
55700-498-20	2024-03-14	C162847	48780-1	1030e365-4872-111a-e063-dadaa90a10e2	Oxycodone and Acetaminophen Tablets, USP CII
55700-498-21	2024-03-14	C162847	48780-1	1030e365-4872-111a-e063-dadaa90a10e2	Oxycodone and Acetaminophen Tablets, USP CII
55700-498-24	2024-03-14	C162847	48780-1	1030e365-4872-111a-e063-dadaa90a10e2	Oxycodone and Acetaminophen Tablets, USP CII
55700-498-28	2024-03-14	C162847	48780-1	1030e365-4872-111a-e063-dadaa90a10e2	Oxycodone and Acetaminophen Tablets, USP CII
55700-498-30	2024-03-14	C162847	48780-1	1030e365-4872-111a-e063-dadaa90a10e2	Oxycodone and Acetaminophen Tablets, USP CII
55700-498-40	2024-03-14	C162847	48780-1	1030e365-4872-111a-e063-dadaa90a10e2	Oxycodone and Acetaminophen Tablets, USP CII
55700-498-56	2024-03-14	C162847	48780-1	1030e365-4872-111a-e063-dadaa90a10e2	Oxycodone and Acetaminophen Tablets, USP CII
55700-498-60	2024-03-14	C162847	48780-1	1030e365-4872-111a-e063-dadaa90a10e2	Oxycodone and Acetaminophen Tablets, USP CII
55700-498-90	2024-03-14	C162847	48780-1	1030e365-4872-111a-e063-dadaa90a10e2	Oxycodone and Acetaminophen Tablets, USP CII
55700-498-01	2024-01-30	C162847	48780-1	1030e365-4872-111a-e063-dadaa90a10e2	Oxycodone and Acetaminophen Tablets, USP CII
55700-498-05	2024-01-30	C162847	48780-1	1030e365-4872-111a-e063-dadaa90a10e2	Oxycodone and Acetaminophen Tablets, USP CII
55700-498-10	2024-01-30	C162847	48780-1	1030e365-4872-111a-e063-dadaa90a10e2	Oxycodone and Acetaminophen Tablets, USP CII
55700-498-14	2024-01-30	C162847	48780-1	1030e365-4872-111a-e063-dadaa90a10e2	Oxycodone and Acetaminophen Tablets, USP CII
55700-498-15	2024-01-30	C162847	48780-1	1030e365-4872-111a-e063-dadaa90a10e2	Oxycodone and Acetaminophen Tablets, USP CII
55700-498-20	2024-01-30	C162847	48780-1	1030e365-4872-111a-e063-dadaa90a10e2	Oxycodone and Acetaminophen Tablets, USP CII
55700-498-21	2024-01-30	C162847	48780-1	1030e365-4872-111a-e063-dadaa90a10e2	Oxycodone and Acetaminophen Tablets, USP CII
55700-498-24	2024-01-30	C162847	48780-1	1030e365-4872-111a-e063-dadaa90a10e2	Oxycodone and Acetaminophen Tablets, USP CII
55700-498-28	2024-01-30	C162847	48780-1	1030e365-4872-111a-e063-dadaa90a10e2	Oxycodone and Acetaminophen Tablets, USP CII
55700-498-30	2024-01-30	C162847	48780-1	1030e365-4872-111a-e063-dadaa90a10e2	Oxycodone and Acetaminophen Tablets, USP CII
55700-498-40	2024-01-30	C162847	48780-1	1030e365-4872-111a-e063-dadaa90a10e2	Oxycodone and Acetaminophen Tablets, USP CII
55700-498-56	2024-01-30	C162847	48780-1	1030e365-4872-111a-e063-dadaa90a10e2	Oxycodone and Acetaminophen Tablets, USP CII
55700-498-60	2024-01-30	C162847	48780-1	1030e365-4872-111a-e063-dadaa90a10e2	Oxycodone and Acetaminophen Tablets, USP CII
55700-498-90	2024-01-30	C162847	48780-1	1030e365-4872-111a-e063-dadaa90a10e2	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
55700-498-01	EA - Each	55700-498	a81c0ca7-9c4b-4685-af5d-725237ae5a5f	1	2017-03-06
55700-498-05	EA - Each	55700-498	6f85bbb2-6bd2-4ac6-9539-21471a87a053	1	2020-01-03
55700-498-10	EA - Each	55700-498	b23440ed-edaf-4d5d-a0b2-96539fb304a4	1	2019-07-02
55700-498-14	EA - Each	55700-498	65930224-e728-4548-a31a-316f314b8ed0	1	2017-05-04
55700-498-15	EA - Each	55700-498	9e30711b-368f-4e1b-ad7d-abdeaff64813	1	2017-03-06
55700-498-20	EA - Each	55700-498	9d9a0df1-3f24-403a-a6c3-1e8b3a8b8e14	1	2017-03-06
55700-498-21	EA - Each	55700-498	058da635-685f-4d59-a12f-f61846ce9a3b	1	2017-05-04
55700-498-24	EA - Each	55700-498	bb421720-89df-443d-8ef7-c9829e07b307	1	2020-08-06
55700-498-30	EA - Each	55700-498	28827b28-0266-4abb-a2b6-1087f475907c	1	2017-03-06
55700-498-40	EA - Each	55700-498	2e0511fc-181e-4596-9256-285e352e0c6e	1	2017-03-06
55700-498-60	EA - Each	55700-498	102cdfb3-a54b-4dbd-bb3a-253a49f7eff9	1	2017-03-06
55700-498-90	EA - Each	55700-498	da303743-cd40-4863-a27d-422da9c0c59d	1	2017-03-06

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55700-498-01	55700049801	120 TABLET in 1 BOTTLE (55700-498-01)	120 tablet	2017-02-10	0000-00-00	No	No	Current
55700-498-05	55700049805	5 TABLET in 1 BOTTLE (55700-498-05)	5 tablet	2019-11-20	0000-00-00	No	No	Current
55700-498-10	55700049810	10 TABLET in 1 BOTTLE (55700-498-10)	10 tablet	2019-06-14	0000-00-00	No	No	Current
55700-498-14	55700049814	14 TABLET in 1 BOTTLE (55700-498-14)	14 tablet	2017-04-14	0000-00-00	No	No	Current
55700-498-15	55700049815	15 TABLET in 1 BOTTLE (55700-498-15)	15 tablet	2017-02-10	0000-00-00	No	No	Current
55700-498-21	55700049821	21 TABLET in 1 BOTTLE (55700-498-21)	21 tablet	2017-04-14	0000-00-00	No	No	Current
55700-498-24	55700049824	24 TABLET in 1 BOTTLE (55700-498-24)	24 tablet	2020-06-17	0000-00-00	No	No	Current
55700-498-28	55700049828	21 TABLET in 1 BOTTLE (55700-498-28)	21 tablet	2019-11-08	0000-00-00	No	No	Current
55700-498-30	55700049830	30 TABLET in 1 BOTTLE (55700-498-30)	30 tablet	2017-02-10	0000-00-00	No	No	Current
55700-498-40	55700049840	40 TABLET in 1 BOTTLE (55700-498-40)	40 tablet	2017-02-10	0000-00-00	No	No	Current
55700-498-56	55700049856	56 TABLET in 1 BOTTLE (55700-498-56)	56 tablet	2018-08-10	0000-00-00	No	No	Current
55700-498-60	55700049860	60 TABLET in 1 BOTTLE (55700-498-60)	60 tablet	2017-02-10	0000-00-00	No	No	Current
55700-498-90	55700049890	90 TABLET in 1 BOTTLE (55700-498-90)	90 tablet	2017-02-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Oxycodone and Acetaminophen Tablets, USP CII	Quality Care Products LLC	2024-03-14	Human Prescription Drug Label	22