VIDAZA

Product NDC: 59572-102
11-digit product format: 595720102
Labeler code: 59572
Product ID: 59572-102_8cba79e2-11fa-4eb9-87e7-827ca781fbf3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: azacitidine
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS; SUBCUTANEOUS
Labeler: Celgene Corporation
Application: NDA050794
Marketing category: NDA
Marketing start: 2004-07-05
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: 2026-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: VIDAZA
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AZACITIDINE	100 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
485246	Internal RxNorm lookup
545206	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
3495a71a-cc04-4776-851f-f185956f32af	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0a0a0250-9871-4046-8497-d10e54e52bd8	Product name	1	20210510
5cc97977-a1c6-de11-70e0-61007eeef82d	Product name	6	20180820

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59572-102-01	VIDAZA	1 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	1		22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59572-102-01	EA - Each	59572-102	bd86fdfd-ebab-451d-ba41-19f01717603f	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
AZACITIDINE	ACTIVE INGREDIENT	M801H13NRU	VIDAZA (AZACITIDINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CELGENE CORPORATION]	10
AZACITIDINE	ACTIVE MOIETY	M801H13NRU	VIDAZA (AZACITIDINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CELGENE CORPORATION]	10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59572-102	VIDAZA (AZACITIDINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CELGENE CORPORATION]	22	Current NDC, Legacy NDC, 1 package rows	20240130_3495a71a-cc04-4776-851f-f185956f32af.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
VIDAZA	AZACITIDINE	Celgene Corporation	3495a71a-cc04-4776-851f-f185956f32af	2024-01-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050794 application number: NDA050794 ndc (product): 59572-102

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
485246	azaCITIDine 100 MG Injection	PSN	3495a71a-cc04-4776-851f-f185956f32af	22
545206	Vidaza 100 MG Injection	PSN	3495a71a-cc04-4776-851f-f185956f32af	22
545206	azacitidine 100 MG Injection [Vidaza]	SBD	3495a71a-cc04-4776-851f-f185956f32af	22
485246	azacitidine 100 MG Injection	SCD	3495a71a-cc04-4776-851f-f185956f32af	22
545206	Vidaza 100 MG Injection	SY	3495a71a-cc04-4776-851f-f185956f32af	22

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
59572-102-01	59572010201	1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (59572-102-01)	2004-07-05	0000-00-00	No	No	Current