Azacitidine

Product NDC: 43598-305
11-digit product format: 435980305
Labeler code: 43598
Product ID: 43598-305_35e92030-ae2f-04b2-c3de-69f8c8da6b82
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Azacitidine
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS; SUBCUTANEOUS
Labeler: Dr. Reddy's Laboratories Inc.
Application: ANDA201537
Marketing category: ANDA
Marketing start: 2013-09-19
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: 2027-12-31
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
A201537-001	AZACITIDINE	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP		2013-09-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201537-001	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	A201537-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2013-09-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201537-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2013-09-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201537-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2013-09-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201537-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2013-09-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201537-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2013-09-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201537-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2013-09-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201537-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2013-09-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201537-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2013-09-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201537-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2013-09-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201537-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2013-09-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201537-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2013-09-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201537-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2013-09-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201537-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2013-09-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201537-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2013-09-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201537-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2013-09-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201537-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2013-09-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201537-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2013-09-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201537-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2013-09-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201537-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2013-09-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201537-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2013-09-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201537-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2013-09-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201537-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2013-09-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201537-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2013-09-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201537-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2013-09-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201537-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2013-09-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201537-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2013-09-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201537-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2013-09-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201537-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2013-09-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201537-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2013-09-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201537-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2013-09-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201537-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2013-09-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201537-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2013-09-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201537-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2013-09-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201537-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2013-09-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201537-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2013-09-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201537-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2013-09-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201537-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2013-09-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201537-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2013-09-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201537-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2013-09-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201537-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2013-09-16	`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	A201537-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201537-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201537-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201537-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201537-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201537-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201537-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201537-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201537-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201537-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201537-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201537-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201537-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201537-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201537-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201537-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201537-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201537-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201537-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201537-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201537-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201537-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201537-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201537-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201537-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201537-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201537-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201537-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201537-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201537-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201537-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201537-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201537-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201537-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201537-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201537-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201537-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201537-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201537-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201537-001	AP	1	`e64feba35796…`

Additional Listing Data#

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

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
71d8d758-86c9-b571-aed1-719654fd4b82	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
43598-305-62	Azacitidine	1 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	1		23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43598-305-62	EA - Each	43598-305	f1de3791-f761-4f68-adef-9e1a255de66a	1	2013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Azacitidine	ACTIVE INGREDIENT	M801H13NRU	AZACITIDINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [DR. REDDY'S LABORATORIES INC.]	10
Azacitidine	ACTIVE MOIETY	M801H13NRU	AZACITIDINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [DR. REDDY'S LABORATORIES INC.]	10
mannitol	INACTIVE INGREDIENT	3OWL53L36A	AZACITIDINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [DR. REDDY'S LABORATORIES INC.]	10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43598-305	AZACITIDINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [DR. REDDY'S LABORATORIES INC.]	21	Current NDC, Legacy NDC, 1 package rows	20240810_71d8d758-86c9-b571-aed1-719654fd4b82.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Azacitidine	AZACITIDINE	BluePoint Laboratories.	cd9db533-8a49-4d01-99e2-b2db8db1ed38	2026-03-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201537 application number: ANDA201537
Azacitidine	AZACITIDINE	Dr. Reddy's Laboratories Inc.	060d56e7-1a24-87c1-7f40-149ecf424f7c	2024-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201537 application number: ANDA201537
Azacitidine	AZACITIDINE	Dr. Reddy's Laboratories Inc.	71d8d758-86c9-b571-aed1-719654fd4b82	2024-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201537 application number: ANDA201537 ndc (product): 43598-305
Azacitidine	AZACITIDINE	Dr. Reddy's Laboratories Inc.	33397835-15a9-d89f-bd75-8b915f5c4dbf	2024-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201537 application number: ANDA201537
Azacitidine	AZACITIDINE	NorthStar RxLLC	81366ec1-9689-4857-ded6-3d6342fe5132	2024-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201537 application number: ANDA201537

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	71d8d758-86c9-b571-aed1-719654fd4b82	23
485246	azacitidine 100 MG Injection	SCD	71d8d758-86c9-b571-aed1-719654fd4b82	23

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
43598-305-62	43598030562	1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (43598-305-62)	2013-09-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Azacitidine	Dr. Reddy's Laboratories Inc. \| Dr.Reddy's Laboratories Ltd-FTO 7 \| Dr.Reddy's Laboratories Ltd-FTO 11	2024-07-31	HUMAN PRESCRIPTION DRUG LABEL	23