Home NDC 63323-572 CLOFARABINE
Product NDC 63323-572
11-digit product format 633230572
Labeler code 63323
Product ID 63323-572_5d0113e4-7027-4908-a76d-46eac772e404
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name clofarabine
Dosage form INJECTION
Route INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA204029
Marketing category ANDA
Marketing start 2017-05-10
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 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 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 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…2022-10-28 04:53 UTC 2022-10 A204029-001 CLOFARABINE 20MG/20ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2017-05-09 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A204029-001 CLOFARABINE 20MG/20ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2017-05-09 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A204029-001 CLOFARABINE 20MG/20ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2017-05-09 cb3db0bc1861…
Observed Orange Book normalized TE history# 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63323-572-70 CLOFARABINE 20 mL in 1 VIAL, SINGLE-USE INJECTION 20 3 63323-572-70 CLOFARABINE 1 in 1 CARTON INJECTION 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-572 CLOFARABINE INJECTION [FRESENIUS KABI USA, LLC] 3 Current NDC, Legacy NDC, 2 package rows 20200715_fe6ff0f9-7610-4a69-9b75-da7ec4bb7744.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 63323-572-70 63323057270 1 VIAL, SINGLE-USE in 1 CARTON (63323-572-70) / 20 mL in 1 VIAL, SINGLE-USE 2017-05-10 0000-00-00 No No Current