Decitabine

Product NDC: 68001-713
11-digit product format: 680010713
Labeler code: 68001
Product ID: 68001-713_5975fa95-f937-4e2d-e063-6394a90a0a46
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Decitabine
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: BluePoint Laboratories
Application: ANDA212265
Marketing category: ANDA
Marketing start: 2026-08-31
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 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
2026-09-14 22:38:34	2026-08	A212265-001	DECITABINE	50MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2019-08-28	`84e616aacf4f…`
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…`

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
2026-09-14 22:38:34	2026-08	A212265-001	AP	1	`84e616aacf4f…`
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…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DECITABINE	50 mg/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
776B62CQ27	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
636631	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
5975fa81-1e29-4d56-e063-6394a90a9cd5	Available on FDA.report

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
Decitabine	DECITABINE	BluePoint Laboratories	5975fa81-1e29-4d56-e063-6394a90a9cd5	2026-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212265 application number: ANDA212265 ndc (product): 68001-713
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	Sample	Exclude flag	Status
68001-713-37	68001071337	1 VIAL, SINGLE-DOSE in 1 CARTON (68001-713-37) / 10 mL in 1 VIAL, SINGLE-DOSE	2026-08-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Decitabine	BluePoint Laboratories \| Novadoz Pharmaceuticals LLC \| MSN LABORATORIES PRIVATE LIMITED	2026-08-20	HUMAN PRESCRIPTION DRUG LABEL	1