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 44 .
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 2026-10-15 13:18:30 2026-09 A216510-001 NELARABINE 250MG/50ML (5MG/ML) INJECTABLE / INTRAVENOUS AP 2024-09-05 c2088c7a36db…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
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