Arranon

Product NDC: 0078-0683
Requested package NDC: 0078-0683-61
11-digit product format: 000780683
Labeler code: 0078
Product ID: 0078-0683_6b71b057-dcb0-4ef0-8f20-887b870c4590
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: nelarabine
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Novartis Pharmaceuticals Corporation
Application: NDA021877
Marketing category: NDA
Marketing start: 2016-10-05
Marketing end: 0000-00-00
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: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0078-0683	0078-0683-61	D	Discontinued by firm		2026-10-05

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
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 · 43 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
2026-09-14 22:38:34	2026-08	N021877-001	ARRANON	250MG/50ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2005-10-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021877-001	ARRANON	250MG/50ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2005-10-28	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N021877-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021877-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021877-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021877-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021877-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021877-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021877-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021877-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021877-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021877-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021877-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021877-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021877-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021877-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021877-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021877-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021877-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021877-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021877-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N021877-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021877-001	AP	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021877-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021877-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021877-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021877-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021877-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021877-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021877-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021877-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021877-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021877-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021877-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021877-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021877-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021877-001	AP	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
68e3b4d6-92e5-2b85-ee38-af06171b640c	Product name	6	20250331

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0078-0683-06	Arranon	6 in 1 CARTON	INJECTION	6	10
0078-0683-06	Arranon	50 mL in 1 VIAL	INJECTION	50	10
0078-0683-61	Arranon	50 mL in 1 VIAL	INJECTION	50	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0078-0683-06	ML - Milliliter	0078-0683	dd29a18d-7d73-410e-ba1b-c98f0f5e5533	1	2016-11-08
0078-0683-61	ML - Milliliter	0078-0683	ffe8c991-8d5e-414e-8018-fa0e8c516ee1	1	2016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0078-0683	ARRANON (NELARABINE) INJECTION [NOVARTIS PHARMACEUTICALS CORPORATION]	10	Legacy NDC, 3 package rows	20250322_fffa5d75-0dba-4ad7-a252-5f60fa28489a.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Arranon	NELARABINE	Sandoz Inc	0f9051de-5c4d-4c0f-8c19-e15214498cca	2025-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021877 application number: NDA021877
Arranon	NELARABINE	Novartis Pharmaceuticals Corporation	fffa5d75-0dba-4ad7-a252-5f60fa28489a	2025-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021877 application number: NDA021877 ndc (package): 0078-0683-61 ndc (product): 0078-0683 ndc11 (package): 00078068361

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
60158CV180	NELARABINE	121032-29-9	NELARABINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
616366	ARRANON 250 MG in 50 ML Injection	PSN	fffa5d75-0dba-4ad7-a252-5f60fa28489a	10
603566	nelarabine 250 MG in 50 ML Injection	PSN	fffa5d75-0dba-4ad7-a252-5f60fa28489a	10
616366	50 ML nelarabine 5 MG/ML Injection [Arranon]	SBD	fffa5d75-0dba-4ad7-a252-5f60fa28489a	10
603566	50 ML nelarabine 5 MG/ML Injection	SCD	fffa5d75-0dba-4ad7-a252-5f60fa28489a	10
616366	Arranon 250 MG per 50 ML Injection	SY	fffa5d75-0dba-4ad7-a252-5f60fa28489a	10
603566	nelarabine 250 MG per 50 ML Injection	SY	fffa5d75-0dba-4ad7-a252-5f60fa28489a	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0078-0683-61	00078068361	50 mL in 1 VIAL (0078-0683-61)	50 ml	2019-08-02	0000-00-00	No	No	Current