Home NDC 66758-165 Arranon
Product NDC 66758-165
11-digit product format 667580165
Labeler code 66758
Product ID 66758-165_0015d51c-784c-4f0d-938c-6c81decd5903
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name nelarabine
Dosage form INJECTION
Route INTRAVENOUS
Labeler Sandoz Inc
Application NDA021877
Marketing category NDA
Marketing start 2016-10-05
Substance NELARABINE
Active strength 5 mg/mL
Pharmacologic classes Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 N021877-001 ARRANON NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2005-10-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021877-001 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 N021877-001 ARRANON 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2005-10-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021877-001 ARRANON 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2005-10-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021877-001 ARRANON 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2005-10-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021877-001 ARRANON 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2005-10-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021877-001 ARRANON 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2005-10-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021877-001 ARRANON 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2005-10-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021877-001 ARRANON 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2005-10-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021877-001 ARRANON 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2005-10-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021877-001 ARRANON 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2005-10-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021877-001 ARRANON 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2005-10-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021877-001 ARRANON 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2005-10-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021877-001 ARRANON 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2005-10-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021877-001 ARRANON 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2005-10-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021877-001 ARRANON 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2005-10-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021877-001 ARRANON 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2005-10-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021877-001 ARRANON 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2005-10-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021877-001 ARRANON 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2005-10-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021877-001 ARRANON 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2005-10-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021877-001 ARRANON 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2005-10-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021877-001 ARRANON 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2005-10-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021877-001 ARRANON 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2005-10-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021877-001 ARRANON 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2005-10-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021877-001 ARRANON 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2005-10-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021877-001 ARRANON 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2005-10-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021877-001 ARRANON 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2005-10-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021877-001 ARRANON 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2005-10-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021877-001 ARRANON 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS RLD, RS 2005-10-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021877-001 ARRANON 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2005-10-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021877-001 ARRANON 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2005-10-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021877-001 ARRANON 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2005-10-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021877-001 ARRANON 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2005-10-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021877-001 ARRANON 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2005-10-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021877-001 ARRANON 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2005-10-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021877-001 ARRANON 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2005-10-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021877-001 ARRANON 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2005-10-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021877-001 ARRANON 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2005-10-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021877-001 ARRANON 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2005-10-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021877-001 ARRANON 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2005-10-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021877-001 ARRANON 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2005-10-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021877-001 ARRANON 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2005-10-28 cb3db0bc1861…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Arranon
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NELARABINE 5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 60158CV180 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 603566 Internal RxNorm lookup 616366 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 66758-165-94 Arranon 1 in 1 CARTON INJECTION 1 4 66758-165-94 Arranon 50 mL in 1 VIAL INJECTION 50 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66758-165 ARRANON (NELARABINE) INJECTION [SANDOZ INC] 2 Current NDC, 2 package rows 20250322_0f9051de-5c4d-4c0f-8c19-e15214498cca.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 Sample Exclude flag Status 66758-165-94 66758016594 1 VIAL in 1 CARTON (66758-165-94) / 50 mL in 1 VIAL 1 vial 2025-09-05 No No Current