clofarabine

Product NDC: 67457-546
11-digit product format: 674570546
Labeler code: 67457
Product ID: 67457-546_91ccea15-3700-4756-a4c6-e1121b95ef99
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: clofarabine
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Mylan Institutional LLC
Application: ANDA208860
Marketing category: ANDA
Marketing start: 2017-11-06
Marketing end: 2026-05-31
Substance: CLOFARABINE
Active strength: 1 mg/mL
Pharmacologic classes: Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
NDC exclude flag: No
Current FDA listing: Yes

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	67457-546		D	Discontinued by firm		2026-08-03
excluded package	package	67457-546	67457-546-20	D	Discontinued by firm		2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A208860-001	CLOFARABINE	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS			2017-11-06

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
2026-02-19 14:30 UTC	2026-02	A208860-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-11-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208860-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-11-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208860-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-11-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208860-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-11-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208860-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-11-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208860-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-11-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208860-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-11-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208860-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-11-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208860-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-11-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208860-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-11-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208860-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-11-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208860-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-11-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208860-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-11-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208860-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-11-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208860-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-11-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208860-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-11-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208860-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-11-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208860-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-11-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208860-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-11-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208860-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-11-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208860-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-11-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208860-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-11-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208860-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-11-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208860-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-11-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208860-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-11-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208860-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-11-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208860-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-11-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208860-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-11-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208860-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-11-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208860-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-11-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208860-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-11-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208860-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-11-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208860-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-11-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208860-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-11-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208860-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-11-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208860-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-11-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208860-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-11-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208860-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-11-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208860-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-11-06	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208860-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-11-06	`cb3db0bc1861…`

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	A208860-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208860-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208860-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208860-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208860-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208860-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208860-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208860-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208860-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208860-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208860-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208860-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208860-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208860-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208860-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208860-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208860-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208860-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208860-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208860-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208860-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208860-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208860-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208860-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208860-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208860-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208860-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208860-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208860-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208860-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208860-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208860-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208860-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208860-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208860-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208860-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208860-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208860-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208860-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208860-001	AP	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
539f51b2-42f0-18ba-d69a-4dc0951237b7	Product name	7	20250107
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67457-546-20	clofarabine	20 mL in 1 VIAL, SINGLE-DOSE	INJECTION	20		5
67457-546-20	clofarabine	1 in 1 CARTON	INJECTION	1		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67457-546-20	ML - Milliliter	67457-546	71faefd9-50ac-406d-b670-e6bcf37ed954	1	2017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67457-546	CLOFARABINE INJECTION [MYLAN INSTITUTIONAL LLC]	5	Current NDC, Legacy NDC, 2 package rows	20250104_1f8ac128-c25d-41f4-9f90-410a792acd66.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
762RDY0Y2H	CLOFARABINE	123318-82-1	CLOFARABINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
67457-546-20	67457054620	1 VIAL, SINGLE-DOSE in 1 CARTON (67457-546-20) / 20 mL in 1 VIAL, SINGLE-DOSE	2017-11-06	2026-05-31	No	No	Current