Home NDC 0143-9871 Cladribine
Product NDC 0143-9871
11-digit product format 001439871
Labeler code 0143
Product ID 0143-9871_5aef0cdc-fa27-47a1-8cce-2a3201aba276
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cladribine
Dosage form INJECTION
Route INTRAVENOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA075405
Marketing category ANDA
Marketing start 2000-02-28
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 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 A075405-001 CLADRIBINE CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2000-02-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075405-001 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.
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 A075405-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2000-02-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075405-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2000-02-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075405-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2000-02-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075405-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2000-02-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075405-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2000-02-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075405-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2000-02-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075405-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2000-02-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075405-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2000-02-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075405-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2000-02-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075405-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2000-02-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075405-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2000-02-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075405-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2000-02-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075405-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2000-02-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075405-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2000-02-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075405-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2000-02-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075405-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2000-02-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075405-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2000-02-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075405-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2000-02-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075405-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2000-02-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075405-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2000-02-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075405-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2000-02-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075405-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2000-02-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075405-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2000-02-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075405-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2000-02-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075405-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2000-02-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075405-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2000-02-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075405-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2000-02-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075405-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2000-02-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075405-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2000-02-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075405-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2000-02-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075405-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2000-02-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075405-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2000-02-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075405-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2000-02-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075405-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2000-02-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075405-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2000-02-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075405-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2000-02-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075405-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2000-02-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075405-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2000-02-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075405-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2000-02-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075405-001 CLADRIBINE 1MG/ML INJECTABLE / INJECTION AP 2000-02-28 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0143-9871-01 Cladribine 10 mL in 1 VIAL INJECTION 10 5 0143-9871-01 Cladribine 1 in 1 BOX, UNIT-DOSE INJECTION 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0143-9871 CLADRIBINE INJECTION [HIKMA PHARMACEUTICALS USA INC.] 5 Current NDC, Legacy NDC, 2 package rows 20230420_5736aecc-cc1d-47dd-86c0-5fb2e9d70f61.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 · 1 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 0143-9871-01 00143987101 1 VIAL in 1 BOX, UNIT-DOSE (0143-9871-01) / 10 mL in 1 VIAL 1 vial 2000-02-28 0000-00-00 No No Current