Azacitidine

Product NDC: 71288-115
11-digit product format: 712880115
Labeler code: 71288
Product ID: 71288-115_bad343f5-0c12-47de-93e7-9b2af3670b7c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Azacitidine
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS; SUBCUTANEOUS
Labeler: Meitheal Pharmaceuticals Inc.
Application: ANDA212128
Marketing category: ANDA
Marketing start: 2020-11-02
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
A212128-001	AZACITIDINE	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP		2020-11-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212128-001	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.

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	A212128-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2020-11-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212128-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2020-11-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212128-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2020-11-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212128-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2020-11-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212128-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2020-11-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212128-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2020-11-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212128-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2020-11-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212128-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2020-11-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212128-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2020-11-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212128-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2020-11-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212128-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2020-11-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212128-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2020-11-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212128-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2020-11-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212128-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2020-11-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212128-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2020-11-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212128-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2020-11-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212128-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2020-11-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212128-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2020-11-02	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212128-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2020-11-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212128-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2020-11-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212128-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2020-11-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212128-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2020-11-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212128-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2020-11-02	`8869cabd3fbd…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212128-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2020-11-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212128-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2020-11-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212128-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2020-11-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212128-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2020-11-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212128-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2020-11-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212128-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2020-11-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212128-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2020-11-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212128-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2020-11-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212128-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2020-11-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212128-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2020-11-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212128-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2020-11-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212128-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2020-11-02	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212128-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2020-11-02	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212128-001	AZACITIDINE	100MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	2020-11-02	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A212128-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212128-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212128-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212128-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212128-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212128-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212128-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212128-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212128-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212128-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212128-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212128-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212128-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212128-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212128-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212128-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212128-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212128-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212128-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212128-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212128-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212128-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212128-001	AP	1	`8869cabd3fbd…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212128-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212128-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212128-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212128-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212128-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212128-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212128-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212128-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212128-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212128-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212128-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212128-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212128-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212128-001	AP	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: 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
97b0917a-03fa-4cc4-91cf-1bed57a988c9	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
71288-115-30	Azacitidine	1 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	1		8
71288-115-30	Azacitidine	1 in 1 VIAL, SINGLE-DOSE	INJECTION, POWDER, LYOPHILIZED,	1		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71288-115-30	EA - Each	71288-115	d2d5963e-2a1d-4058-82ba-d5f33fcb0d38	1	2021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71288-115	AZACITIDINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.]	7	Current NDC, Legacy NDC, 2 package rows	20250417_97b0917a-03fa-4cc4-91cf-1bed57a988c9.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Azacitidine	AZACITIDINE	Meitheal Pharmaceuticals Inc.	3b96b508-046b-49ae-aefe-6d39c89a1d0e	2025-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212128 application number: ANDA212128
Azacitidine	AZACITIDINE	Meitheal Pharmaceuticals Inc.	97b0917a-03fa-4cc4-91cf-1bed57a988c9	2025-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212128 application number: ANDA212128 ndc (product): 71288-115

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	97b0917a-03fa-4cc4-91cf-1bed57a988c9	8
485246	azacitidine 100 MG Injection	SCD	97b0917a-03fa-4cc4-91cf-1bed57a988c9	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71288-115-30	71288011530	1 VIAL, SINGLE-DOSE in 1 CARTON (71288-115-30) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE	2020-11-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Azacitidine	Meitheal Pharmaceuticals Inc. \| Kindos Pharmaceuticals, Co., Ltd.	2025-07-21	HUMAN PRESCRIPTION DRUG LABEL	8