Application 200534

Type: NDA
Sponsor: GENUS LIFESCIENCES

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	CAPSULE;ORAL	5MG	Yes	Yes

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N200534-001	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N200534-001	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 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N200534-001	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	RLD, RS	2010-10-20	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	N200534-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N200534-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200534-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N200534-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200534-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200534-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200534-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200534-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200534-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N200534-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N200534-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N200534-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N200534-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N200534-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N200534-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N200534-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N200534-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N200534-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N200534-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N200534-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N200534-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N200534-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N200534-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N200534-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N200534-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N200534-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N200534-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N200534-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N200534-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N200534-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N200534-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N200534-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N200534-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N200534-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N200534-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N200534-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N200534-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N200534-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N200534-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N200534-001	AB	1	`e64feba35796…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200534-001	M-14	2024-07-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200534-001	M-14	2024-07-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200534-001	M-14	2024-07-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N200534-001	M-14	2024-07-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N200534-001	M-14	2024-07-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N200534-001	M-14	2024-07-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N200534-001	M-14	2024-07-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N200534-001	M-14	2024-07-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N200534-001	M-14	2024-07-21	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N200534-001	M-14	2024-07-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N200534-001	M-14	2024-07-21	`1c564ffb4f44…`

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 4 · 79 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	Name fallback brand name: OXYCODONE HYDROCHLORIDE generic name: OXYCODONE HYDROCHLORIDE
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	585405bc-8b85-286f-e063-6394a90aa5cd	2026-08-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone Hydrochloride generic name: OXYCODONE HYDROCHLORIDE
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	KVK-Tech, Inc.	744f5d1c-7427-492c-8994-c8e817793e53	2026-07-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: OXYCODONE HYDROCHLORIDE generic name: OXYCODONE HYDROCHLORIDE
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	57afed61-79db-ca43-e063-6394a90a68eb	2026-07-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone Hydrochloride generic name: OXYCODONE HYDROCHLORIDE
Oxycodone Hydrochloride	OXYCODONE	Major Pharmaceuticals	6b6db42b-9821-4aa6-8566-297037d84079	2026-07-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone Hydrochloride
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	3ccf459a-fb11-e137-e063-6394a90a5a80	2026-07-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: OXYCODONE HYDROCHLORIDE generic name: OXYCODONE HYDROCHLORIDE
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	Bryant Ranch Prepack	685d9709-028e-4422-bf0c-fde577b718a2	2026-07-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: OXYCODONE HYDROCHLORIDE generic name: OXYCODONE HYDROCHLORIDE
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Eywa Pharma Inc	c801963d-f54d-4ed5-82c4-8b278528d3dc	2026-06-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone Hydrochloride generic name: OXYCODONE HYDROCHLORIDE
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Bryant Ranch Prepack	bb33bf7f-aa70-4e8a-91b2-4e0400dc328e	2026-06-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone Hydrochloride generic name: OXYCODONE HYDROCHLORIDE
OxyContin	OXYCODONE HYDROCHLORIDE	Knoa Pharma LLC	bfdfe235-d717-4855-a3c8-a13d26dadede	2026-06-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: OXYCODONE HYDROCHLORIDE
Oxycodone Hydrochloride	OXYCODONE	Amneal Pharmaceuticals LLC	094b64b3-cd32-4de5-afb6-ea00d9caad74	2026-06-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone Hydrochloride
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Bryant Ranch Prepack	0e4dd113-87ab-4a5d-846a-446db3cfd469	2026-06-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone Hydrochloride generic name: OXYCODONE HYDROCHLORIDE
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Bryant Ranch Prepack	e84ea009-3cab-4721-bd21-1123eccce515	2026-06-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone Hydrochloride generic name: OXYCODONE HYDROCHLORIDE
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	KVK-TECH,INC	e73897d6-b920-4300-a564-5dbc9c8e9fe9	2026-06-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: OXYCODONE HYDROCHLORIDE generic name: OXYCODONE HYDROCHLORIDE
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	Redpharm Drug	5301d432-7fca-2d72-e063-6394a90a18a4	2026-05-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: OXYCODONE HYDROCHLORIDE generic name: OXYCODONE HYDROCHLORIDE
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Bryant Ranch Prepack	27124cdf-a3e8-474c-9c1e-6fa48f6ddc05	2026-05-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone Hydrochloride generic name: OXYCODONE HYDROCHLORIDE
Oxycodone Hydrochloride	OXYCODONE	Redpharm Drug	525001a6-68d8-7ef7-e063-6294a90abc5f	2026-05-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone Hydrochloride
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	ST. MARY'S MEDICAL PARK PHARMACY	424fdfc7-1c92-2e62-e063-6394a90a136b	2026-05-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: OXYCODONE HYDROCHLORIDE generic name: OXYCODONE HYDROCHLORIDE
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	c2c57ae7-86b9-47bb-a31b-ed1c4327ce7f	2026-05-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: OXYCODONE HYDROCHLORIDE generic name: OXYCODONE HYDROCHLORIDE
Oxycodone Hydrochloride	OXYCODONE HYDROCHLORIDE	Rhodes Pharmaceuticals LLC	a5162476-1217-41c0-bc7e-0a0f123f069f	2026-05-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Oxycodone Hydrochloride generic name: OXYCODONE HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63629-3803	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
64950-901	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Genus Lifesciences Inc.	NDA	Current
64950-901	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Genus Lifesciences Inc.	NDA	Current
64950-901	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Genus Lifesciences Inc.	NDA	Current
64950-901	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Genus Lifesciences Inc.	NDA	Current
68462-204	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Glenmark Pharmaceuticals, Inc	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84638	SUPPL	2026-01-05
84568	SUPPL	2025-12-29
80080	SUPPL	2024-11-04
78217	SUPPL	2024-04-23
78216	SUPPL	2024-04-23
78187	SUPPL	2024-04-22
77052	SUPPL	2023-12-19
76944	SUPPL	2023-12-18
76240	ORIG	2023-11-03
68171	SUPPL	2021-07-23
68170	SUPPL	2021-07-23
68159	SUPPL	2021-07-22
66629	SUPPL	2021-03-08
66628	SUPPL	2021-03-08
66571	SUPPL	2021-03-08
60449	SUPPL	2019-10-09
60395	SUPPL	2019-10-08
60394	SUPPL	2019-10-08
55999	SUPPL	2018-10-17
55998	SUPPL	2018-10-17
55728	SUPPL	2018-10-01
55727	SUPPL	2018-10-01
46412	SUPPL	2016-12-21
46327	SUPPL	2016-12-20
44822	ORIG	2011-02-24
22832	ORIG	2011-02-24
32031	ORIG	2010-10-26
18963	ORIG	2010-10-21