Clolar

Product NDC
0024-5860
11-digit product format
000245860
Labeler code
0024
Product ID
0024-5860_6da3b3b5-9695-4d88-b19c-b4ee259da417
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clofarabine
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Sanofi-Aventis U.S. LLC
Application
NDA021673
Marketing category
NDA
Marketing start
2013-04-01
Marketing end
0000-00-00
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
2023-12-31
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0024-5860DDiscontinued by firm2026-08-03
excluded packagepackage0024-58600024-5860-01DDiscontinued by firm2026-08-03

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 · 14 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0024-5860-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0024-5860-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0024-5860-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0024-5860-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0024-5860-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0024-5860-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0024-5860-01302b2466d912…e7b80fea0513…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021673-001CLOLARCLOFARABINE20MG/20ML (1MG/ML)SOLUTION / INTRAVENOUSRLD2004-12-28

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021673-001CLOLAR20MG/20ML (1MG/ML)SOLUTION / INTRAVENOUSRLD2004-12-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021673-001CLOLAR20MG/20ML (1MG/ML)SOLUTION / INTRAVENOUSRLD2004-12-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N021673-001CLOLAR20MG/20ML (1MG/ML)SOLUTION / INTRAVENOUSRLD2004-12-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021673-001CLOLAR20MG/20ML (1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2004-12-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021673-001CLOLAR20MG/20ML (1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2004-12-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021673-001CLOLAR20MG/20ML (1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2004-12-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021673-001CLOLAR20MG/20ML (1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2004-12-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021673-001CLOLAR20MG/20ML (1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2004-12-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021673-001CLOLAR20MG/20ML (1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2004-12-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021673-001CLOLAR20MG/20ML (1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2004-12-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021673-001CLOLAR20MG/20ML (1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2004-12-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021673-001CLOLAR20MG/20ML (1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2004-12-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021673-001CLOLAR20MG/20ML (1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2004-12-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021673-001CLOLAR20MG/20ML (1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2004-12-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021673-001CLOLAR20MG/20ML (1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2004-12-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021673-001CLOLAR20MG/20ML (1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2004-12-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021673-001CLOLAR20MG/20ML (1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2004-12-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021673-001CLOLAR20MG/20ML (1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2004-12-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021673-001CLOLAR20MG/20ML (1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2004-12-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021673-001CLOLAR20MG/20ML (1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2004-12-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021673-001CLOLAR20MG/20ML (1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2004-12-2887673890dc5c…
2021-03-12 10:30 UTC2021-03N021673-001CLOLAR20MG/20ML (1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2004-12-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021673-001CLOLAR20MG/20ML (1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2004-12-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021673-001CLOLAR20MG/20ML (1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2004-12-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021673-001CLOLAR20MG/20ML (1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2004-12-283f01610625f2…
2019-09-15 20:21 UTC2019-09N021673-001CLOLAR20MG/20ML (1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2004-12-28b00525d2431f…
2019-07-19 19:46 UTC2019-07N021673-001CLOLAR20MG/20ML (1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2004-12-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021673-001CLOLAR20MG/20ML (1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2004-12-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021673-001CLOLAR20MG/20ML (1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2004-12-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021673-001CLOLAR20MG/20ML (1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2004-12-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021673-001CLOLAR20MG/20ML (1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2004-12-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021673-001CLOLAR20MG/20ML (1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2004-12-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021673-001CLOLAR20MG/20ML (1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2004-12-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021673-001CLOLAR20MG/20ML (1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2004-12-283f0d92c62455…
2023-05-13 08:27 UTC2023-05N021673-001CLOLAR20MG/20ML (1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2004-12-28053a50430f4f…
2023-01-26 05:58 UTC2023-01N021673-001CLOLAR20MG/20ML (1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2004-12-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021673-001CLOLAR20MG/20ML (1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2004-12-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021673-001CLOLAR20MG/20ML (1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2004-12-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021673-001CLOLAR20MG/20ML (1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2004-12-28e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021673-001CLOLAR20MG/20ML (1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2004-12-28cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021673-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021673-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021673-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021673-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021673-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021673-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021673-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021673-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021673-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021673-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021673-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021673-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021673-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021673-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021673-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021673-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021673-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021673-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03N021673-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021673-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021673-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021673-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09N021673-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07N021673-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021673-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021673-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021673-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021673-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021673-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021673-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021673-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05N021673-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01N021673-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021673-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021673-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021673-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021673-001AP1cb3db0bc1861…

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0024-5860-01ML - Milliliter0024-5860d15ab507-f0c3-45bd-90f2-39ac62fa6a2a12015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLOFARABINEACTIVE INGREDIENT762RDY0Y2HCLOLAR (CLOFARABINE) INJECTION [SANOFI-AVENTIS U.S. LLC]3
CLOFARABINEACTIVE MOIETY762RDY0Y2HCLOLAR (CLOFARABINE) INJECTION [SANOFI-AVENTIS U.S. LLC]3
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XCLOLAR (CLOFARABINE) INJECTION [SANOFI-AVENTIS U.S. LLC]3
WATERINACTIVE INGREDIENT059QF0KO0RCLOLAR (CLOFARABINE) INJECTION [SANOFI-AVENTIS U.S. LLC]3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0024-5860-01000245860011 VIAL, SINGLE-USE in 1 BOX (0024-5860-01) > 20 mL in 1 VIAL, SINGLE-USE2013-04-010000-00-00NoNoCurrent