AZACITIDINE

Product NDC: 43598-678
11-digit product format: 435980678
Labeler code: 43598
Product ID: 43598-678_b7d42845-1888-66b9-77a0-c6f4902e21ac
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: AZACITIDINE
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS; SUBCUTANEOUS
Labeler: Dr. Reddy's Laboratories Inc.
Application: ANDA207518
Marketing category: ANDA
Marketing start: 2017-12-13
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 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
A207518-001	AZACITIDINE	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP		2016-09-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207518-001	AP

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A207518-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2016-09-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207518-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2016-09-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207518-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2016-09-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207518-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2016-09-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207518-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2016-09-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207518-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2016-09-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207518-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2016-09-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207518-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2016-09-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207518-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2016-09-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207518-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2016-09-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207518-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2016-09-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207518-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2016-09-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207518-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2016-09-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207518-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2016-09-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207518-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2016-09-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207518-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2016-09-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207518-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2016-09-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207518-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2016-09-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207518-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2016-09-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207518-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2016-09-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207518-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2016-09-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207518-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2016-09-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207518-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2016-09-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207518-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2016-09-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207518-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2016-09-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207518-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2016-09-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207518-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2016-09-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207518-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2016-09-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207518-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2016-09-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207518-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2016-09-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207518-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2016-09-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207518-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2016-09-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207518-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2016-09-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207518-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2016-09-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207518-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2016-09-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207518-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2016-09-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207518-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2016-09-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207518-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2016-09-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207518-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2016-09-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207518-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2016-09-29	`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	A207518-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207518-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207518-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207518-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207518-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207518-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207518-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207518-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207518-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207518-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207518-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207518-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207518-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207518-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207518-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207518-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207518-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207518-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207518-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207518-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207518-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207518-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207518-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207518-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207518-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207518-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207518-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207518-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207518-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207518-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207518-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207518-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207518-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207518-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207518-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207518-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207518-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207518-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207518-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207518-001	AP	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: AZACITIDINE
Brand name suffix: AZACITIDINE
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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
485246	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
d38a1247-28c8-a911-e691-a983a2f9a6e3	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
43598-678-11	AZACITIDINE AZACITIDINE	1 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	1		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43598-678-11	EA - Each	43598-678	bf78bc79-9651-415e-b875-0c3ba5f825dd	1	2018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43598-678	AZACITIDINE AZACITIDINE (AZACITIDINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [DR. REDDY'S LABORATORIES INC.]	2	Current NDC, Legacy NDC, 1 package rows	20181206_d38a1247-28c8-a911-e691-a983a2f9a6e3.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AZACITIDINE	AZACITIDINE	Armas Pharmaceuticals Inc.	5c0a2d5f-8c34-4c04-8425-7543965cedd4	2025-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207518 application number: ANDA207518
Azacitidine	AZACITIDINE	Fresenius Kabi USA, LLC	3b594aba-e798-4105-b801-0b0d970747c1	2025-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207518 application number: ANDA207518
AZACITIDINE	AZACITIDINE FOR	Pilnova Pharma Inc	0095c67b-42f3-47e6-92db-f77843727bca	2024-12-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207518 application number: ANDA207518
AZACITIDINE AZACITIDINE	AZACITIDINE	Dr. Reddy's Laboratories Inc.	d38a1247-28c8-a911-e691-a983a2f9a6e3	2017-07-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207518 application number: ANDA207518 ndc (product): 43598-678

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	d38a1247-28c8-a911-e691-a983a2f9a6e3	2
485246	azacitidine 100 MG Injection	SCD	d38a1247-28c8-a911-e691-a983a2f9a6e3	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
43598-678-11	43598067811	1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (43598-678-11)	2017-12-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
AZACITIDINE AZACITIDINE	Dr. Reddy's Laboratories Inc. \| Shilpa Medicare Limited	2017-07-20	HUMAN PRESCRIPTION DRUG LABEL	2