DECITABINE

Product NDC: 50742-430
11-digit product format: 507420430
Labeler code: 50742
Product ID: 50742-430_c71b018e-22c6-4c0f-a8e8-6e320822e092
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: decitabine
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Ingenus Pharmaceuticals, LLC
Application: ANDA210984
Marketing category: ANDA
Marketing start: 2019-09-25
Marketing end: 0000-00-00
Substance: DECITABINE
Active strength: 50 mg/1
Pharmacologic classes: Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	50742-430		D	Discontinued by firm		2026-10-23
excluded package	package	50742-430	50742-430-01	D	Discontinued by firm		2026-10-23

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A210984-001	DECITABINE	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS			2019-09-16

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
2026-10-15 13:18:30	2026-09	A210984-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS		2019-09-16	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A210984-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS		2019-09-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210984-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS		2019-09-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210984-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-09-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210984-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-09-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210984-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-09-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210984-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-09-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210984-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-09-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210984-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-09-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210984-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-09-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210984-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-09-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210984-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-09-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210984-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-09-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210984-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-09-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210984-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-09-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210984-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-09-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210984-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-09-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210984-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-09-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210984-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-09-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210984-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-09-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210984-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-09-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210984-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-09-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210984-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-09-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210984-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-09-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210984-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-09-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210984-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-09-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210984-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-09-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210984-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-09-16	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210984-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-09-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210984-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-09-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210984-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-09-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210984-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-09-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210984-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-09-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210984-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-09-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210984-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-09-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210984-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-09-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210984-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-09-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210984-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-09-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210984-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-09-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210984-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-09-16	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A210984-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210984-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210984-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210984-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210984-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210984-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210984-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210984-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210984-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210984-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210984-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210984-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210984-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210984-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210984-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210984-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210984-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210984-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210984-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210984-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210984-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210984-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210984-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210984-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210984-001	AP	1	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210984-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210984-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210984-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210984-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210984-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210984-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210984-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210984-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210984-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210984-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210984-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210984-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210984-001	AP	1	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4b7700e3-6e0e-45e5-9d22-6f754d61386e	Product name	2	20250304
ba82e818-f876-42bf-ac8a-edb0f7670e1b	Product name	1	20210121
871786fd-2c42-643c-2a8f-45c433540e89	Product name	9	20190709

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50742-430-01	EA - Each	50742-430	62255550-ab6d-441e-92fb-f3d033088416	1	2019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50742-430	DECITABINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [INGENUS PHARMACEUTICALS, LLC]	11	Legacy NDC	20241115_b3a26585-e247-4b2e-a4ce-817b3aac2ff3.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
776B62CQ27	DECITABINE	2353-33-5	DECITABINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50742-430-01	50742043001	1 VIAL in 1 CARTON (50742-430-01) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL	1 vial	2019-09-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DECITABINE	Ingenus Pharmaceuticals, LLC \| Novast Laboratories, Ltd. \| Ingenus Pharmaceuticals GmbH	2022-09-15	HUMAN PRESCRIPTION DRUG LABEL	10