Home NDC 39822-0650 Nelarabine
Product NDC 39822-0650
11-digit product format 398220650
Labeler code 39822
Product ID 39822-0650_3b16087f-ced1-c8bc-e063-6294a90a51cb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nelarabine
Dosage form INJECTION
Route INTRAVENOUS
Labeler XGen Pharmaceuticals DJB, Inc.
Application ANDA216510
Marketing category ANDA
Marketing start 2025-02-17
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 43 .
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 A216510-001 NELARABINE NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-09-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216510-001 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 2026-09-14 22:38:34 2026-08 A216510-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-09-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 A216510-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-09-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216510-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-09-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216510-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-09-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216510-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-09-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216510-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-09-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216510-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-09-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216510-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-09-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216510-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-09-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216510-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-09-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216510-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-09-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216510-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-09-05 d06236e962d9…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216510-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-09-05 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Nelarabine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NELARABINE 5 mg/mL
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 39822-0650-1 Nelarabine 1 in 1 CARTON INJECTION 1 2 39822-0650-1 Nelarabine 50 mL in 1 VIAL INJECTION 50 2 39822-0650-6 Nelarabine 6 in 1 CARTON INJECTION 6 2 39822-0650-6 Nelarabine 50 mL in 1 VIAL INJECTION 50 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 39822-0650 NELARABINE INJECTION [XGEN PHARMACEUTICALS DJB, INC.] 2 Current NDC, 4 package rows 20250221_a1cc1580-50d9-4b9b-a002-1fc6686a9515.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 Sample Exclude flag Status 39822-0650-1 39822065001 1 VIAL in 1 CARTON (39822-0650-1) / 50 mL in 1 VIAL 1 vial 2025-02-17 No No Current 39822-0650-6 39822065006 6 VIAL in 1 CARTON (39822-0650-6) / 50 mL in 1 VIAL 6 vial 2025-02-17 No No Current