Home NDC 42658-010 Cladribine
Product NDC 42658-010
11-digit product format 426580010
Labeler code 42658
Product ID 42658-010_2c5c0edf-8718-40f2-e063-6294a90aacd0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cladribine
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Hisun Pharmaceuticals USA, Inc.
Application ANDA210856
Marketing category ANDA
Marketing start 2020-05-18
Substance CLADRIBINE
Active strength 1 mg/mL
Pharmacologic classes Purine Antimetabolite [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 42658-010-91 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 42658-010-91 0efc9e666f02…f202fb6c5f17…
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 A210856-001 CLADRIBINE CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2019-11-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210856-001 AP
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 RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A210856-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2019-11-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210856-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2019-11-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210856-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2019-11-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210856-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2019-11-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210856-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2019-11-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210856-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2019-11-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210856-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2019-11-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210856-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2019-11-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210856-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2019-11-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210856-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2019-11-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210856-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2019-11-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210856-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2019-11-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210856-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2019-11-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210856-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2019-11-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210856-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2019-11-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210856-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2019-11-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210856-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2019-11-25 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A210856-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2019-11-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210856-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2019-11-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210856-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2019-11-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210856-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2019-11-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210856-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2019-11-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A210856-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2019-11-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A210856-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2019-11-25 3f01610625f2…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210856-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2019-11-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210856-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2019-11-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210856-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2019-11-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210856-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2019-11-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210856-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2019-11-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210856-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2019-11-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210856-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2019-11-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210856-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2019-11-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210856-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2019-11-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210856-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2019-11-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210856-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2019-11-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A210856-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2019-11-25 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A210856-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2019-11-25 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A210856-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2019-11-25 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Cladribine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLADRIBINE 1 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 47M74X9YT5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 240754 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42658-010-01 Cladribine 1 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 1 6 42658-010-91 Cladribine 1 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42658-010 CLADRIBINE INJECTION, SOLUTION [HISUN PHARMACEUTICALS USA, INC.] 5 Current NDC, Legacy NDC, 1 package rows 20240228_71c39b37-33b5-42e1-bf4f-93ff751cc7fe.zip 42658-010 CLADRIBINE INJECTION, SOLUTION [HISUN PHARMACEUTICALS USA, INC.] 2 Current NDC, Legacy NDC, 1 package rows 20250125_f538cba9-001a-4a21-e053-2a95a90a00ec.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 Units Marketing start Marketing end Sample Exclude flag Status 42658-010-01 42658001001 1 mL in 1 VIAL, SINGLE-DOSE (42658-010-01) 1 ml 2020-05-18 0000-00-00 No No Current 42658-010-91 42658001091 1 mL in 1 VIAL, SINGLE-DOSE (42658-010-91) 1 ml 2023-02-28 No No Current