Home NDC 49315-003 CLOFARABINE
Product NDC 49315-003
11-digit product format 493150003
Labeler code 49315
Product ID 49315-003_a6a1f86a-61c0-4769-8f6a-2b7af01c1410
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name clofarabine
Dosage form INJECTION
Route INTRAVENOUS
Labeler Zydus Lifesciences Limited
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 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
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 49315-003-06 49315000306 1 VIAL, SINGLE-USE in 1 CARTON (49315-003-06) / 20 mL in 1 VIAL, SINGLE-USE 2017-05-10 0000-00-00 No No Current