CLOFARABINE

Product NDC: 55150-326
11-digit product format: 551500326
Labeler code: 55150
Product ID: 55150-326_18adf4af-63ed-41e6-ab59-87085ce3e5fb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CLOFARABINE
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Eugia US LLC
Application: ANDA212457
Marketing category: ANDA
Marketing start: 2022-10-03
Substance: CLOFARABINE
Active strength: 1 mg/mL
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 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
A212457-001	CLOFARABINE	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS			2022-10-03

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
2026-02-19 14:30 UTC	2026-02	A212457-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS		2022-10-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212457-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS		2022-10-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212457-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS		2022-10-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212457-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS		2022-10-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212457-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS		2022-10-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212457-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS		2022-10-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212457-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS		2022-10-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212457-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS		2022-10-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212457-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS		2022-10-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212457-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS		2022-10-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212457-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS		2022-10-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212457-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS		2022-10-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212457-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS		2022-10-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212457-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS		2022-10-03	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212457-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS		2022-10-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212457-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS		2022-10-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212457-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS		2022-10-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212457-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS		2022-10-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212457-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS		2022-10-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212457-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS		2022-10-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212457-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS		2022-10-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212457-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS		2022-10-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212457-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-10-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212457-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-10-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212457-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-10-03	`f41ea6bd6efb…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212457-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS		2022-10-03	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2023-01-26 05:58 UTC	2023-01	A212457-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212457-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212457-001	AP	1	`f41ea6bd6efb…`

Additional Listing Data#

Finished product: Yes
Brand name base: CLOFARABINE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CLOFARABINE	1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
762RDY0Y2H	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
486419	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
18adf4af-63ed-41e6-ab59-87085ce3e5fb	Available on FDA.report

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
55150-326-01	CLOFARABINE	1 in 1 CARTON	INJECTION	1		1
55150-326-01	CLOFARABINE	20 mL in 1 VIAL, SINGLE-DOSE	INJECTION	20		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55150-326	CLOFARABINE INJECTION [EUGIA US LLC]	1	Current NDC, Legacy NDC, 2 package rows	20221011_18adf4af-63ed-41e6-ab59-87085ce3e5fb.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CLOFARABINE	CLOFARABINE	Eugia US LLC	18adf4af-63ed-41e6-ab59-87085ce3e5fb	2022-10-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212457 application number: ANDA212457 ndc (product): 55150-326

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
486419	clofarabine 20 MG in 20 ML Injection	PSN	18adf4af-63ed-41e6-ab59-87085ce3e5fb	1
486419	20 ML clofarabine 1 MG/ML Injection	SCD	18adf4af-63ed-41e6-ab59-87085ce3e5fb	1
486419	clofarabine 20 MG per 20 ML Injection	SY	18adf4af-63ed-41e6-ab59-87085ce3e5fb	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
55150-326-01	55150032601	1 VIAL, SINGLE-DOSE in 1 CARTON (55150-326-01) / 20 mL in 1 VIAL, SINGLE-DOSE	2022-10-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CLOFARABINE	Eugia US LLC \| EUGIA Pharma Specialities Limited	2022-10-10	Human Prescription Drug Label	1