Azacitidine

Product NDC: 0781-3253
Requested package NDC: 0781-3253-94
11-digit product format: 007813253
Labeler code: 0781
Product ID: 0781-3253_84226739-5b8c-4e28-a17e-793af710a06f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: azacitidine
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS; SUBCUTANEOUS
Labeler: Sandoz Inc
Application: NDA050794
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2013-09-16
Marketing end: 2025-02-28
Substance: AZACITIDINE
Active strength: 100 mg/1
Pharmacologic classes: Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

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	0781-3253	0781-3253-94	D	Discontinued by firm		2026-08-11

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 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`

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

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
N050794-001	VIDAZA	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2004-05-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N050794-001	AP

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N050794-001	ODE-399	2029-05-20

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 · 41 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
2026-02-19 14:30 UTC	2026-02	N050794-001	VIDAZA	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2004-05-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050794-001	VIDAZA	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2004-05-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050794-001	VIDAZA	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2004-05-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050794-001	VIDAZA	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2004-05-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050794-001	VIDAZA	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2004-05-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050794-001	VIDAZA	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2004-05-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050794-001	VIDAZA	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2004-05-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050794-001	VIDAZA	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2004-05-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050794-001	VIDAZA	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2004-05-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050794-001	VIDAZA	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2004-05-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050794-001	VIDAZA	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2004-05-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050794-001	VIDAZA	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2004-05-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050794-001	VIDAZA	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2004-05-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050794-001	VIDAZA	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2004-05-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050794-001	VIDAZA	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2004-05-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050794-001	VIDAZA	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2004-05-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050794-001	VIDAZA	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2004-05-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050794-001	VIDAZA	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2004-05-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050794-001	VIDAZA	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2004-05-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050794-001	VIDAZA	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2004-05-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050794-001	VIDAZA	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2004-05-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050794-001	VIDAZA	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2004-05-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050794-001	VIDAZA	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2004-05-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050794-001	VIDAZA	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2004-05-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050794-001	VIDAZA	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2004-05-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050794-001	VIDAZA	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2004-05-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050794-001	VIDAZA	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2004-05-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050794-001	VIDAZA	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2004-05-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050794-001	VIDAZA	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2004-05-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050794-001	VIDAZA	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2004-05-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050794-001	VIDAZA	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2004-05-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050794-001	VIDAZA	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2004-05-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050794-001	VIDAZA	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2004-05-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050794-001	VIDAZA	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2004-05-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050794-001	VIDAZA	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2004-05-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050794-001	VIDAZA	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2004-05-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050794-001	VIDAZA	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2004-05-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050794-001	VIDAZA	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2004-05-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050794-001	VIDAZA	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2004-05-19	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050794-001	VIDAZA	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2004-05-19	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	N050794-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050794-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050794-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050794-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050794-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050794-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050794-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050794-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050794-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050794-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050794-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050794-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050794-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050794-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050794-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050794-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050794-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050794-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050794-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050794-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050794-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050794-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050794-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050794-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050794-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050794-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050794-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050794-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050794-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050794-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050794-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050794-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050794-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050794-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050794-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050794-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050794-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050794-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050794-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050794-001	AP	1	`cb3db0bc1861…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 49 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N050794-001	ODE-399	2029-05-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050794-001	I-889	2025-05-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050794-001	ODE-399	2029-05-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050794-001	I-889	2025-05-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050794-001	ODE-399	2029-05-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050794-001	I-889	2025-05-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050794-001	ODE-399	2029-05-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050794-001	I-889	2025-05-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050794-001	ODE-399	2029-05-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050794-001	I-889	2025-05-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050794-001	ODE-399	2029-05-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050794-001	I-889	2025-05-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050794-001	ODE-399	2029-05-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050794-001	I-889	2025-05-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050794-001	ODE-399	2029-05-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050794-001	I-889	2025-05-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050794-001	ODE-399	2029-05-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050794-001	I-889	2025-05-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050794-001	ODE-399	2029-05-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050794-001	I-889	2025-05-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050794-001	ODE-399	2029-05-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050794-001	I-889	2025-05-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050794-001	ODE-399	2029-05-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050794-001	I-889	2025-05-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050794-001	ODE-399	2029-05-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050794-001	I-889	2025-05-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N050794-001	ODE-399	2029-05-20	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050794-001	I-889	2025-05-20	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050794-001	ODE-399	2029-05-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050794-001	I-889	2025-05-20	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N050794-001	ODE-399	2029-05-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050794-001	I-889	2025-05-20	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N050794-001	ODE-399	2029-05-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050794-001	I-889	2025-05-20	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050794-001	ODE-399	2029-05-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050794-001	I-889	2025-05-20	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050794-001	ODE-399	2029-05-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050794-001	I-889	2025-05-20	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050794-001	ODE-399	2029-05-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050794-001	I-889	2025-05-20	`3f0d92c62455…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0781-3253-94	EA - Each	0781-3253	9d40bc00-71c7-4016-b43e-eb8d24591664	1	2013-11-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AZACITIDINE	ACTIVE INGREDIENT	M801H13NRU	AZACITIDINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SANDOZ INC]	12
AZACITIDINE	ACTIVE MOIETY	M801H13NRU	AZACITIDINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SANDOZ INC]	12
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	AZACITIDINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SANDOZ INC]	12

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
VIDAZA	AZACITIDINE	Celgene Corporation	3495a71a-cc04-4776-851f-f185956f32af	2024-01-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050794 application number: NDA050794

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0781-3253-94	00781325394	1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (0781-3253-94)	2013-09-16	2025-02-28	No	No	Current