Clofarabine Injection, for Intravenous use

Manufacturer: Zydus Lifesciences Limited
Effective date: 2022-10-18
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 20:44:26

Label at a glance#

ProductCLOFARABINE

Active ingredientCLOFARABINE

Label structure2 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 49315-003-06

Rx only

Clofarabine Injection 20 mg/20 mL (1 mg/mL)

Must Be Diluted Prior To Intravenous Use

Contains 1 (20 mL) Single-Dose Vial

Sterile

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 49315-003-06

Clofarabine Injection 20 mg/20 mL (1 mg/mL)

Must Be Diluted Prior To Intravenous Use

Rx only Single-Dose Vial

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
486419	clofarabine 20 MG in 20 ML Injection	PSN	2
486419	20 ML clofarabine 1 MG/ML Injection	SCD	2
486419	clofarabine 20 MG per 20 ML Injection	SY	2

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
CLOFARABINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
539f51b2-42f0-18ba-d69a-4dc0951237b7	Product name	7	20250107

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49315-003-06	CLOFARABINE	20 mL in 1 VIAL, SINGLE-USE	INJECTION	20		2
49315-003-06	CLOFARABINE	1 in 1 CARTON	INJECTION	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49315-003	CLOFARABINE INJECTION [ZYDUS LIFESCIENCES LIMITED]	2	Current NDC, Legacy NDC, 2 package rows	20221019_4d8d8e81-01ba-4493-b458-7f6375c5bbae.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

CLOFARABINE
SODIUM CHLORIDE
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
49315-003	49315-003-06

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CLOFARABINE	762RDY0Y2H	ACTIB
SODIUM CHLORIDE	451W47IQ8X	IACT
WATER	059QF0KO0R	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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
A204029-001	CLOFARABINE	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS			2017-05-09

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 · 44 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	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS		2017-05-09	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS		2017-05-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS		2017-05-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS		2017-05-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS		2017-05-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS		2017-05-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS		2017-05-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS		2017-05-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS		2017-05-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-05-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-05-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-05-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-05-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-05-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-05-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-05-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-05-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-05-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-05-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-05-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-05-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-05-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-05-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-05-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-05-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-05-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-05-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-05-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-05-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-05-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-05-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-05-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-05-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-05-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-05-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-05-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-05-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-05-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-05-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204029-001	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2017-05-09	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204029-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204029-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204029-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204029-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204029-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204029-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204029-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204029-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204029-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204029-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204029-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204029-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204029-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204029-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204029-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204029-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204029-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204029-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204029-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204029-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204029-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204029-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204029-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204029-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204029-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204029-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204029-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204029-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204029-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204029-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204029-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204029-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204029-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204029-001	AP	1	`cb3db0bc1861…`

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	Zydus Lifesciences Limited	4d8d8e81-01ba-4493-b458-7f6375c5bbae	2022-10-18		Exact identifier ndc (package): 49315-003-06 ndc (product): 49315-003 ndc11 (package): 49315000306 spl id: a6a1f86a-61c0-4769-8f6a-2b7af01c1410 spl set id: 4d8d8e81-01ba-4493-b458-7f6375c5bbae

Reported adverse events (FAERS/openFDA)#

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