Application 076758

Type: ANDA
Sponsor: SPECGX LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	TABLET;ORAL	15MG	No	No
002	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	TABLET;ORAL	30MG	No	No
003	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	TABLET;ORAL	5MG	No	No
004	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	TABLET;ORAL	10MG	No	No
005	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	TABLET;ORAL	20MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A076758-001	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2004-06-30
A076758-002	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2004-06-30
A076758-003	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2007-03-19
A076758-004	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-10-12
A076758-005	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2021-10-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A076758-001	AB
A076758-002	AB
A076758-003	AB
A076758-004	AB
A076758-005	AB

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 · 194 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	A076758-001	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2004-06-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076758-002	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2004-06-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076758-003	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2007-03-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076758-004	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-10-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076758-005	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2021-10-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076758-001	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2004-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076758-002	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2004-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076758-003	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2007-03-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076758-004	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-10-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076758-005	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2021-10-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076758-001	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2004-06-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076758-002	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2004-06-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076758-003	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2007-03-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076758-004	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-10-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076758-005	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2021-10-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076758-001	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2004-06-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076758-002	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2004-06-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076758-003	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2007-03-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076758-004	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-10-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076758-005	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2021-10-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076758-001	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2004-06-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076758-002	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2004-06-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076758-003	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2007-03-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076758-004	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-10-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076758-005	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2021-10-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076758-001	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2004-06-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076758-002	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2004-06-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076758-003	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2007-03-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076758-004	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-10-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076758-005	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2021-10-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076758-001	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2004-06-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076758-002	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2004-06-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076758-003	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2007-03-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076758-004	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-10-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076758-005	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2021-10-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076758-001	OXYCODONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2004-06-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076758-002	OXYCODONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2004-06-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076758-003	OXYCODONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2007-03-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076758-004	OXYCODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-10-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076758-005	OXYCODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2021-10-12	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 194 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	A076758-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076758-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076758-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076758-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076758-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076758-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076758-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076758-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076758-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076758-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076758-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076758-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076758-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076758-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076758-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076758-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076758-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076758-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076758-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076758-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076758-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076758-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076758-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076758-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076758-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076758-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076758-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076758-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076758-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076758-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076758-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076758-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076758-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076758-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076758-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076758-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076758-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076758-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076758-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076758-005	AB	1	`2680178bc6a6…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	SpecGx LLC	928227bf-89c5-4c64-9823-0e84cc669388	2026-08-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076758 application number: ANDA076758 ndc (product): 0406-8530 ndc (product): 0406-8520 ndc (product): 0406-8510 ndc (product): 0406-0552 ndc (product): 0406-8515
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	Redpharm Drug	5301d432-7fca-2d72-e063-6394a90a18a4	2026-05-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076758 application number: ANDA076758 ndc (product): 67296-0425
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	RedPharm Drug, Inc.	92614a3a-331d-16ad-e053-2a95a90a47cc	2025-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076758 application number: ANDA076758 ndc (product): 67296-0425

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 26 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0406-0552	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	SpecGx LLC	ANDA	Current
0406-0552	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	SpecGx LLC	ANDA	Current
0406-0552	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	SpecGx LLC	ANDA	Current
0406-0552	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	SpecGx LLC	ANDA	Current
0406-0552	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	SpecGx LLC	ANDA	Current
0406-0552	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	SpecGx LLC	ANDA	Current
0406-8510	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	SpecGx LLC	ANDA	Current
0406-8515	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	SpecGx LLC	ANDA	Current
0406-8515	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	SpecGx LLC	ANDA	Current
0406-8515	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	SpecGx LLC	ANDA	Current
0406-8515	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	SpecGx LLC	ANDA	Current
0406-8515	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	SpecGx LLC	ANDA	Current
0406-8515	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	SpecGx LLC	ANDA	Current
0406-8520	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	SpecGx LLC	ANDA	Current
0406-8530	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	SpecGx LLC	ANDA	Current
0406-8530	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	SpecGx LLC	ANDA	Current
0406-8530	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	SpecGx LLC	ANDA	Current
0406-8530	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	SpecGx LLC	ANDA	Current
0406-8530	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	SpecGx LLC	ANDA	Current
0406-8530	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	SpecGx LLC	ANDA	Current
10544-599	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	Blenheim Pharmacal, Inc.	ANDA	Current
10544-600	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	Blenheim Pharmacal, Inc.	ANDA	Current
66336-135	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	Dispensing Solutions, Inc.	ANDA	Current
66336-470	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	Dispensing Solutions, Inc.	ANDA	Current
67296-0425	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	RedPharm Drug, Inc.	ANDA	Current
67296-0425	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	RedPharm Drug, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76181	ORIG	2023-11-03