Decitabine

Product NDC: 69539-115
11-digit product format: 695390115
Labeler code: 69539
Product ID: 69539-115_57209c15-d635-40bf-9d16-c664ddfc49a4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Decitabine
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: MSN LABORATORIES PRIVATE LIMITED
Application: ANDA212265
Marketing category: ANDA
Marketing start: 2019-08-28
Marketing end: 0000-00-00
Substance: DECITABINE
Active strength: 50 mg/10mL
Pharmacologic classes: Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2021-12-31
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	69539-115		D	Discontinued by firm		2026-08-17
excluded package	package	69539-115	69539-115-01	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	69539-115		D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69539-115	69539-115-01	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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
A212265-001	DECITABINE	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP		2019-08-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212265-001	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 · 41 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	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`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
2026-08-18 06:07:40	2026-07	A212265-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212265-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212265-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212265-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212265-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212265-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212265-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212265-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212265-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212265-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212265-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212265-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212265-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212265-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212265-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212265-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212265-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212265-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A212265-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A212265-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212265-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212265-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212265-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212265-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212265-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A212265-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A212265-001	AP	1	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212265-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212265-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212265-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212265-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212265-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212265-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212265-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212265-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212265-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212265-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212265-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212265-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212265-001	AP	1	`cb3db0bc1861…`

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69539-115	DECITABINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MSN LABORATORIES PRIVATE LIMITED]	6	Legacy NDC	20200906_a3c1551a-41aa-4508-9d88-0210b2d4df78.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
Decitabine	DECITABINE	Bryant Ranch Prepack	c731a9f0-46ee-41c3-8f89-179cab13bdd2	2026-05-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212265 application number: ANDA212265
Decitabine	DECITABINE	Novadoz Pharmaceuticals LLC	a1b43089-bc88-4ac6-bdee-9cc38ec30f4e	2021-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212265 application number: ANDA212265
Decitabine	DECITABINE	Northstar Rx LLC	1abbe952-58bc-4dbc-b06a-fb79167bcd66	2020-08-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212265 application number: ANDA212265
Decitabine	DECITABINE	Novadoz Pharmaceuticals LLC	ae6c4580-3a3a-4c42-903a-1565d79521f8	2020-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212265 application number: ANDA212265

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	Marketing start	Marketing end	Sample	Exclude flag	Status
69539-115-01	69539011501	1 VIAL, SINGLE-USE in 1 CARTON (69539-115-01) > 20 mL in 1 VIAL, SINGLE-USE	2019-08-28	0000-00-00	No	No	Current