Application 040545

Type: ANDA
Sponsor: SPECGX LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	TABLET;ORAL	325MG;7.5MG	No	No
002	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	TABLET;ORAL	325MG;10MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040545-001	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;7.5MG	TABLET / ORAL	AA		2004-06-30
A040545-002	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	325MG;10MG	TABLET / ORAL	AA		2004-06-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A040545-001	AA
A040545-002	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 3 · 82 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	A040545-001	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2004-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040545-002	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2004-06-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040545-001	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2004-06-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040545-002	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2004-06-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040545-001	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2004-06-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040545-002	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2004-06-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040545-001	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2004-06-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040545-002	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2004-06-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040545-001	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2004-06-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040545-002	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2004-06-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040545-001	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2004-06-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040545-002	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2004-06-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040545-001	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2004-06-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040545-002	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2004-06-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040545-001	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2004-06-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040545-002	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2004-06-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040545-001	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2004-06-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040545-002	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2004-06-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040545-001	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2004-06-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040545-002	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2004-06-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040545-001	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2004-06-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040545-002	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2004-06-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040545-001	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2004-06-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040545-002	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2004-06-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040545-001	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2004-06-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040545-002	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2004-06-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040545-001	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2004-06-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040545-002	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2004-06-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040545-001	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2004-06-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040545-002	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2004-06-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040545-001	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2004-06-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040545-002	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2004-06-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040545-001	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2004-06-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040545-002	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2004-06-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040545-001	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2004-06-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040545-002	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2004-06-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040545-001	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2004-06-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040545-002	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2004-06-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040545-001	OXYCODONE AND ACETAMINOPHEN	325MG;7.5MG	TABLET / ORAL	AA	2004-06-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040545-002	OXYCODONE AND ACETAMINOPHEN	325MG;10MG	TABLET / ORAL	AA	2004-06-30	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A040545-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040545-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040545-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040545-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040545-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040545-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040545-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040545-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040545-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040545-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040545-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040545-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040545-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040545-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040545-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040545-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040545-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040545-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040545-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040545-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040545-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040545-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040545-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040545-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040545-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040545-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040545-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040545-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040545-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040545-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040545-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040545-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040545-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040545-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040545-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040545-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040545-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040545-002	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040545-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040545-002	AA	1	`782e0a99824c…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

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

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OXYCODONE AND ACETAMINOPHEN	OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN	SpecGx LLC	f2137f1a-b49a-40bd-97ac-cd6b36e295f4	2026-07-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040545 application number: ANDA040545 ndc (product): 0406-0522 ndc (product): 0406-0523

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0406-0522	OXYCODONE AND ACETAMINOPHEN	oxycodone hydrochloride and acetaminophen	SpecGx LLC	ANDA	Current
0406-0522	OXYCODONE AND ACETAMINOPHEN	oxycodone hydrochloride and acetaminophen	SpecGx LLC	ANDA	Current
0406-0522	OXYCODONE AND ACETAMINOPHEN	oxycodone hydrochloride and acetaminophen	SpecGx LLC	ANDA	Current
0406-0522	OXYCODONE AND ACETAMINOPHEN	oxycodone hydrochloride and acetaminophen	SpecGx LLC	ANDA	Current
0406-0523	OXYCODONE AND ACETAMINOPHEN	oxycodone hydrochloride and acetaminophen	SpecGx LLC	ANDA	Current
0406-0523	OXYCODONE AND ACETAMINOPHEN	oxycodone hydrochloride and acetaminophen	SpecGx LLC	ANDA	Current
0406-0523	OXYCODONE AND ACETAMINOPHEN	oxycodone hydrochloride and acetaminophen	SpecGx LLC	ANDA	Current
0406-0523	OXYCODONE AND ACETAMINOPHEN	oxycodone hydrochloride and acetaminophen	SpecGx LLC	ANDA	Current
21695-233	OXYCODONE AND ACETAMINOPHEN	oxycodone hydrochloride and acetaminophen	Rebel Distributors Corp	ANDA	Current
55700-983	OXYCODONE AND ACETAMINOPHEN	oxycodone hydrochloride and acetaminophen	Quality Care Products, LLC	ANDA	Current
55700-984	OXYCODONE AND ACETAMINOPHEN	oxycodone hydrochloride and acetaminophen	Quality Care Products, LLC	ANDA	Current
66336-147	OXYCODONE AND ACETAMINOPHEN	oxycodone hydrochloride and acetaminophen	Dispensing Solutions, Inc.	ANDA	Current
70518-3492	OXYCODONE AND ACETAMINOPHEN	oxycodone hydrochloride and acetaminophen	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76182	ORIG	2023-11-03