Home NDC 70710-1839 Nelarabine
Product NDC 70710-1839
11-digit product format 707101839
Labeler code 70710
Product ID 70710-1839_a144ddba-18cc-441e-942e-4170b34d4a3e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nelarabine
Dosage form INJECTION
Route INTRAVENOUS
Labeler Zydus Pharmaceuticals USA Inc.
Application ANDA215037
Marketing category ANDA
Marketing start 2022-06-24
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 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 A215037-001 NELARABINE NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2021-11-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215037-001 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 A215037-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2021-11-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215037-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2021-11-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215037-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2021-11-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215037-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2021-11-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215037-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2021-11-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215037-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2021-11-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215037-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2021-11-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215037-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2021-11-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215037-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2021-11-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215037-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2021-11-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215037-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2021-11-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215037-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2021-11-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215037-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2021-11-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215037-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2021-11-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A215037-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2021-11-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A215037-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2021-11-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A215037-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2021-11-17 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A215037-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2021-11-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A215037-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2021-11-17 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215037-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2021-11-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215037-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2021-11-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215037-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2021-11-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215037-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2021-11-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215037-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2021-11-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A215037-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2021-11-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A215037-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2021-11-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A215037-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2021-11-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A215037-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2021-11-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A215037-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2021-11-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A215037-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2021-11-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A215037-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2021-11-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A215037-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2021-11-17 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215037-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2021-11-17 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Nelarabine
Listing expiration 2026-12-31 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 603566 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 70710-1839-1 Nelarabine 50 mL in 1 VIAL, SINGLE-DOSE INJECTION 50 5 70710-1839-1 Nelarabine 1 in 1 CARTON INJECTION 1 5 70710-1839-8 Nelarabine 50 mL in 1 VIAL, SINGLE-DOSE INJECTION 50 5 70710-1839-8 Nelarabine 6 in 1 CARTON INJECTION 6 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70710-1839 NELARABINE INJECTION [ZYDUS PHARMACEUTICALS USA INC.] 5 Current NDC, Legacy NDC, 4 package rows 20250418_8cb23281-93ca-40b8-b8e0-c57dd4298322.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 · 3 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 70710-1839-1 70710183901 1 VIAL, SINGLE-DOSE in 1 CARTON (70710-1839-1) / 50 mL in 1 VIAL, SINGLE-DOSE 2022-06-24 0000-00-00 No No Current 70710-1839-8 70710183908 6 VIAL, SINGLE-DOSE in 1 CARTON (70710-1839-8) / 50 mL in 1 VIAL, SINGLE-DOSE 2022-06-24 0000-00-00 No No Current