ONUREG

Product NDC: 59572-730
11-digit product format: 595720730
Labeler code: 59572
Product ID: 59572-730_6981b224-73db-4a2a-b901-ed7e5bffd5ea
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: azacitidine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Celgene Corporation
Application: NDA214120
Marketing category: NDA
Marketing start: 2020-09-01
Substance: AZACITIDINE
Active strength: 200 mg/1
Pharmacologic classes: Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	59572-730	59572-730-14	D	Discontinued by firm		2026-08-17

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 · 8 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
2022-04-09 23:13 UTC · source 2022-04-08	unfinished product	product		`906f6e251498…`	`bf70b80e44f0…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished package	package	59572-730-00	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished product	product		`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished package	package	59572-730-00	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished product	product		`8fc7167e32ce…`	`e96bbc724034…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished package	package	59572-730-00	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished product	product		`4184dd79f89f…`	`545327b3e20f…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished package	package	59572-730-00	`4184dd79f89f…`	`545327b3e20f…`

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

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
N214120-001	ONUREG	AZACITIDINE	200MG	TABLET / ORAL		RLD	2020-09-01
N214120-002	ONUREG	AZACITIDINE	300MG	TABLET / ORAL		RLD, RS	2020-09-01

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N214120-001	11571436	2029-05-14		Drug product	2023-02-10
N214120-001	12053482	2029-05-14	U-2950		2024-08-28
N214120-001	8846628	2030-06-03	U-2950	Drug product	2020-09-29
N214120-002	11571436	2029-05-14		Drug product	2023-02-10
N214120-002	12053482	2029-05-14	U-2950		2024-08-28
N214120-002	8846628	2030-06-03	U-2950	Drug product	2020-09-29

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N214120-001	ODE-320	2027-09-01
N214120-002	ODE-320	2027-09-01

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 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N214120-001	ONUREG	200MG	TABLET / ORAL	RLD	2020-09-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214120-002	ONUREG	300MG	TABLET / ORAL	RLD, RS	2020-09-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214120-001	ONUREG	200MG	TABLET / ORAL	RLD	2020-09-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214120-002	ONUREG	300MG	TABLET / ORAL	RLD, RS	2020-09-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214120-001	ONUREG	200MG	TABLET / ORAL	RLD	2020-09-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214120-002	ONUREG	300MG	TABLET / ORAL	RLD, RS	2020-09-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214120-001	ONUREG	200MG	TABLET / ORAL	RLD	2020-09-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214120-002	ONUREG	300MG	TABLET / ORAL	RLD, RS	2020-09-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214120-001	ONUREG	200MG	TABLET / ORAL	RLD	2020-09-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214120-002	ONUREG	300MG	TABLET / ORAL	RLD, RS	2020-09-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214120-001	ONUREG	200MG	TABLET / ORAL	RLD	2020-09-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214120-002	ONUREG	300MG	TABLET / ORAL	RLD, RS	2020-09-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214120-001	ONUREG	200MG	TABLET / ORAL	RLD	2020-09-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214120-002	ONUREG	300MG	TABLET / ORAL	RLD, RS	2020-09-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214120-001	ONUREG	200MG	TABLET / ORAL	RLD	2020-09-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214120-002	ONUREG	300MG	TABLET / ORAL	RLD, RS	2020-09-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214120-001	ONUREG	200MG	TABLET / ORAL	RLD	2020-09-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214120-002	ONUREG	300MG	TABLET / ORAL	RLD, RS	2020-09-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214120-001	ONUREG	200MG	TABLET / ORAL	RLD	2020-09-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214120-002	ONUREG	300MG	TABLET / ORAL	RLD, RS	2020-09-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214120-001	ONUREG	200MG	TABLET / ORAL	RLD	2020-09-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214120-002	ONUREG	300MG	TABLET / ORAL	RLD, RS	2020-09-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214120-001	ONUREG	200MG	TABLET / ORAL	RLD	2020-09-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214120-002	ONUREG	300MG	TABLET / ORAL	RLD, RS	2020-09-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214120-001	ONUREG	200MG	TABLET / ORAL	RLD	2020-09-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214120-002	ONUREG	300MG	TABLET / ORAL	RLD, RS	2020-09-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214120-001	ONUREG	200MG	TABLET / ORAL	RLD	2020-09-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214120-002	ONUREG	300MG	TABLET / ORAL	RLD, RS	2020-09-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214120-001	ONUREG	200MG	TABLET / ORAL	RLD	2020-09-01	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N214120-002	ONUREG	300MG	TABLET / ORAL	RLD, RS	2020-09-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214120-001	ONUREG	200MG	TABLET / ORAL	RLD	2020-09-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214120-002	ONUREG	300MG	TABLET / ORAL	RLD, RS	2020-09-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N214120-001	ONUREG	200MG	TABLET / ORAL	RLD	2020-09-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N214120-002	ONUREG	300MG	TABLET / ORAL	RLD, RS	2020-09-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N214120-001	ONUREG	200MG	TABLET / ORAL	RLD	2020-09-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N214120-002	ONUREG	300MG	TABLET / ORAL	RLD, RS	2020-09-01	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N214120-001	ONUREG	200MG	TABLET / ORAL	RLD	2020-09-01	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N214120-002	ONUREG	300MG	TABLET / ORAL	RLD, RS	2020-09-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N214120-001	ONUREG	200MG	TABLET / ORAL	RLD	2020-09-01	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N214120-002	ONUREG	300MG	TABLET / ORAL	RLD, RS	2020-09-01	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 148 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N214120-001	11571436	2029-05-14		Drug product	2023-02-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214120-001	12053482	2029-05-14	U-2950		2024-08-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214120-001	8846628	2030-06-03	U-2950	Drug product	2020-09-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214120-002	11571436	2029-05-14		Drug product	2023-02-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214120-002	12053482	2029-05-14	U-2950		2024-08-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214120-002	8846628	2030-06-03	U-2950	Drug product	2020-09-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214120-001	11571436	2029-05-14		Drug product	2023-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214120-001	12053482	2029-05-14	U-2950		2024-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214120-001	8846628	2030-06-03	U-2950	Drug product	2020-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214120-002	11571436	2029-05-14		Drug product	2023-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214120-002	12053482	2029-05-14	U-2950		2024-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214120-002	8846628	2030-06-03	U-2950	Drug product	2020-09-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214120-001	11571436	2029-05-14		Drug product	2023-02-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214120-001	12053482	2029-05-14	U-2950		2024-08-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214120-001	8846628	2030-06-03	U-2950	Drug product	2020-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214120-002	11571436	2029-05-14		Drug product	2023-02-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214120-002	12053482	2029-05-14	U-2950		2024-08-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214120-002	8846628	2030-06-03	U-2950	Drug product	2020-09-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214120-001	11571436	2029-05-14		Drug product	2023-02-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214120-001	12053482	2029-05-14	U-2950		2024-08-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214120-001	8846628	2030-06-03	U-2950	Drug product	2020-09-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214120-002	11571436	2029-05-14		Drug product	2023-02-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214120-002	12053482	2029-05-14	U-2950		2024-08-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214120-002	8846628	2030-06-03	U-2950	Drug product	2020-09-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214120-001	11571436	2029-05-14		Drug product	2023-02-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214120-001	12053482	2029-05-14	U-2950		2024-08-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214120-001	8846628	2030-06-03	U-2950	Drug product	2020-09-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214120-002	11571436	2029-05-14		Drug product	2023-02-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214120-002	12053482	2029-05-14	U-2950		2024-08-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214120-002	8846628	2030-06-03	U-2950	Drug product	2020-09-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214120-001	11571436	2029-05-14		Drug product	2023-02-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214120-001	12053482	2029-05-14	U-2950		2024-08-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214120-001	8846628	2030-06-03	U-2950	Drug product	2020-09-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214120-002	11571436	2029-05-14		Drug product	2023-02-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214120-002	12053482	2029-05-14	U-2950		2024-08-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214120-002	8846628	2030-06-03	U-2950	Drug product	2020-09-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214120-001	11571436	2029-05-14		Drug product	2023-02-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214120-001	12053482	2029-05-14	U-2950		2024-08-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214120-001	8846628	2030-06-03	U-2950	Drug product	2020-09-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214120-002	11571436	2029-05-14		Drug product	2023-02-10	`03ed91905a0d…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 110 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N214120-001	ODE-320	2027-09-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214120-002	ODE-320	2027-09-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214120-001	ODE-320	2027-09-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214120-002	ODE-320	2027-09-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214120-001	ODE-320	2027-09-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214120-002	ODE-320	2027-09-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214120-001	ODE-320	2027-09-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214120-002	ODE-320	2027-09-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214120-001	ODE-320	2027-09-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214120-002	ODE-320	2027-09-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214120-001	ODE-320	2027-09-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214120-002	ODE-320	2027-09-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214120-001	ODE-320	2027-09-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214120-002	ODE-320	2027-09-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214120-001	ODE-320	2027-09-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214120-002	ODE-320	2027-09-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214120-001	ODE-320	2027-09-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214120-002	ODE-320	2027-09-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214120-001	ODE-320	2027-09-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214120-002	ODE-320	2027-09-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214120-001	ODE-320	2027-09-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214120-002	ODE-320	2027-09-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214120-001	ODE-320	2027-09-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214120-002	ODE-320	2027-09-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214120-001	ODE-320	2027-09-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214120-002	ODE-320	2027-09-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214120-001	ODE-320	2027-09-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214120-002	ODE-320	2027-09-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214120-001	ODE-320	2027-09-01	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N214120-002	ODE-320	2027-09-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214120-001	NP	2023-09-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214120-001	ODE-320	2027-09-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214120-002	NP	2023-09-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214120-002	ODE-320	2027-09-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N214120-001	NP	2023-09-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N214120-001	ODE-320	2027-09-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N214120-002	NP	2023-09-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N214120-002	ODE-320	2027-09-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N214120-001	NP	2023-09-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N214120-001	ODE-320	2027-09-01	`4b0b4de00fa7…`

Additional Listing Data#

Finished product: Yes
Brand name base: ONUREG
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AZACITIDINE	200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
M801H13NRU	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2396764	Internal RxNorm lookup
2396770	Internal RxNorm lookup
2396772	Internal RxNorm lookup
2396774	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0e95e33f-8aba-4f19-b332-2416580d358b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
0a0a0250-9871-4046-8497-d10e54e52bd8	Product name	1	20210510
5cc97977-a1c6-de11-70e0-61007eeef82d	Product name	6	20180820
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59572-730-07	ONUREG	7 in 1 BLISTER PACK	TABLET, FILM COATED	7		13
59572-730-14	ONUREG	14 in 1 BOTTLE	TABLET, FILM COATED	14		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59572-730-07	EA - Each	59572-730	5a0b8611-ea39-462f-b5a3-7db1d15b43c0	1	2021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59572-730	ONUREG (AZACITIDINE) TABLET, FILM COATED [CELGENE CORPORATION]	11	Current NDC, Legacy NDC, 2 package rows	20221102_0e95e33f-8aba-4f19-b332-2416580d358b.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ONUREG	AZACITIDINE	Celgene Corporation	0e95e33f-8aba-4f19-b332-2416580d358b	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 214120 application number: NDA214120 ndc (product): 59572-730

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
M801H13NRU	AZACITIDINE	320-67-2	AZACITIDINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2396764	azaCITIDine 200 MG Oral Tablet	PSN	0e95e33f-8aba-4f19-b332-2416580d358b	13
2396772	azaCITIDine 300 MG Oral Tablet	PSN	0e95e33f-8aba-4f19-b332-2416580d358b	13
2396770	Onureg 200 MG Oral Tablet	PSN	0e95e33f-8aba-4f19-b332-2416580d358b	13
2396774	Onureg 300 MG Oral Tablet	PSN	0e95e33f-8aba-4f19-b332-2416580d358b	13
2396770	azacitidine 200 MG Oral Tablet [Onureg]	SBD	0e95e33f-8aba-4f19-b332-2416580d358b	13
2396774	azacitidine 300 MG Oral Tablet [Onureg]	SBD	0e95e33f-8aba-4f19-b332-2416580d358b	13
2396764	azacitidine 200 MG Oral Tablet	SCD	0e95e33f-8aba-4f19-b332-2416580d358b	13
2396772	azacitidine 300 MG Oral Tablet	SCD	0e95e33f-8aba-4f19-b332-2416580d358b	13
2396770	Onureg 200 MG Oral Tablet	SY	0e95e33f-8aba-4f19-b332-2416580d358b	13
2396774	Onureg 300 MG Oral Tablet	SY	0e95e33f-8aba-4f19-b332-2416580d358b	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
59572-730-07	59572073007	7 TABLET, FILM COATED in 1 BLISTER PACK (59572-730-07)	2020-12-18	0000-00-00	No	No	Current
59572-730-14	59572073014	14 TABLET, FILM COATED in 1 BOTTLE (59572-730-14)	2020-09-01	0000-00-00	No	No	Current