Home NDC 68083-233 Nelarabine
Product NDC 68083-233
11-digit product format 680830233
Labeler code 68083
Product ID 68083-233_a8747c60-a869-4e8b-ad3a-270dfc118180
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nelarabine
Dosage form INJECTION
Route INTRAVENOUS
Labeler Gland Pharma Limited
Application ANDA212605
Marketing category ANDA
Marketing start 2024-01-03
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 A212605-001 NELARABINE NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-01-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212605-001 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 A212605-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-01-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212605-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-01-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212605-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-01-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212605-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-01-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212605-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-01-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212605-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-01-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212605-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-01-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212605-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-01-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212605-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-01-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212605-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-01-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212605-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-01-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212605-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-01-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212605-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-01-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212605-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-01-03 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212605-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-01-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212605-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-01-03 1c564ffb4f44…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212605-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-01-03 a50c72e98297…
Observed Orange Book normalized TE 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 68083-233-01 Nelarabine 50 mL in 1 VIAL, SINGLE-DOSE INJECTION 50 6 68083-233-06 Nelarabine 6 in 1 CARTON INJECTION 6 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68083-233 NELARABINE INJECTION [GLAND PHARMA LIMITED] 6 Current NDC, 2 package rows 20250411_651bf4d2-75b0-4a60-8014-7006ffe61084.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 68083-233-01 68083023301 50 mL in 1 VIAL, SINGLE-DOSE 50 ml Historical 68083-233-06 68083023306 6 VIAL, SINGLE-DOSE in 1 CARTON (68083-233-06) / 50 mL in 1 VIAL, SINGLE-DOSE (68083-233-01) 2024-01-03 No No Current