nelarabine

Product NDC: 81927-111
Requested package NDC: 81927-111-06
11-digit product format: 819270111
Labeler code: 81927
Product ID: 81927-111_f21b358e-9f41-4dc3-858f-b55f9a8af715
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: nelarabine
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Shorla Oncology Inc.
Application: ANDA214809
Marketing category: ANDA
Marketing start: 2023-03-15
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 7 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A214809-001	NELARABINE	NELARABINE	250MG/50ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP		2023-03-03
A214809-002	NELARABINE	NELARABINE	375MG/75ML (5MG/ML)	INJECTABLE / INTRAVENOUS		RS	2025-07-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A214809-001	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
2026-08-18 06:07:40	2026-07	A214809-001	NELARABINE	250MG/50ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP		2023-03-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214809-002	NELARABINE	375MG/75ML (5MG/ML)	INJECTABLE / INTRAVENOUS		RS	2025-07-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214809-001	NELARABINE	250MG/50ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP		2023-03-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214809-002	NELARABINE	375MG/75ML (5MG/ML)	INJECTABLE / INTRAVENOUS		RS	2025-07-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214809-001	NELARABINE	250MG/50ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP		2023-03-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214809-002	NELARABINE	375MG/75ML (5MG/ML)	INJECTABLE / INTRAVENOUS		RS	2025-07-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214809-001	NELARABINE	250MG/50ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP		2023-03-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214809-002	NELARABINE	375MG/75ML (5MG/ML)	INJECTABLE / INTRAVENOUS		RS	2025-07-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214809-001	NELARABINE	250MG/50ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP		2023-03-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214809-001	NELARABINE	250MG/50ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP		2023-03-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214809-001	NELARABINE	250MG/50ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP		2023-03-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214809-001	NELARABINE	250MG/50ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP		2023-03-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214809-001	NELARABINE	250MG/50ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP		2023-03-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214809-001	NELARABINE	250MG/50ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP		2023-03-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214809-001	NELARABINE	250MG/50ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP		2023-03-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214809-001	NELARABINE	250MG/50ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP		2023-03-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214809-001	NELARABINE	250MG/50ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP		2023-03-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214809-001	NELARABINE	250MG/50ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP		2023-03-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214809-001	NELARABINE	250MG/50ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP		2023-03-03	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214809-001	NELARABINE	250MG/50ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP		2023-03-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214809-001	NELARABINE	250MG/50ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP		2023-03-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214809-001	NELARABINE	250MG/50ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP		2023-03-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214809-001	NELARABINE	250MG/50ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP		2023-03-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214809-001	NELARABINE	250MG/50ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP		2023-03-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214809-001	NELARABINE	250MG/50ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP		2023-03-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214809-001	NELARABINE	250MG/50ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP		2023-03-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214809-001	NELARABINE	250MG/50ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP		2023-03-03	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214809-001	NELARABINE	250MG/50ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP		2023-03-03	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214809-002	NELARABINE	375MG/75ML (5MG/ML)	INJECTABLE / INTRAVENOUS		RS	2025-07-16	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A214809-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214809-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214809-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214809-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214809-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214809-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214809-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214809-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214809-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214809-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214809-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214809-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214809-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214809-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214809-001	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214809-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214809-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214809-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214809-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214809-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214809-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214809-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214809-001	AP	1	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214809-001	AP	1	`a50c72e98297…`

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
603566	Internal RxNorm lookup
2722411	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
fc401b06-4e3b-413e-a854-3e031c433862	Available on FDA.report

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
81927-111-01	2025-04-29	These highlights do not include all the information needed to use NELARABINE INJECTION safely and effectively. See full prescribing information for NELARABINE INJECTION. NELARABINE injection, for intravenous use Initial U.S. Approval: 2005
81927-111-06	2025-04-29	These highlights do not include all the information needed to use NELARABINE INJECTION safely and effectively. See full prescribing information for NELARABINE INJECTION. NELARABINE injection, for intravenous use Initial U.S. Approval: 2005
81927-111-01	2025-01-30	These highlights do not include all the information needed to use NELARABINE INJECTION safely and effectively. See full prescribing information for NELARABINE INJECTION. NELARABINE injection, for intravenous use Initial U.S. Approval: 2005
81927-111-06	2025-01-30	These highlights do not include all the information needed to use NELARABINE INJECTION safely and effectively. See full prescribing information for NELARABINE INJECTION. NELARABINE injection, for intravenous use Initial U.S. Approval: 2005

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
81927-111-01	nelarabine	50 mL in 1 VIAL, SINGLE-DOSE	INJECTION	50	6
81927-111-01	nelarabine	1 in 1 CARTON	INJECTION	1	6
81927-111-06	nelarabine	6 in 1 CARTON	INJECTION	6	6
81927-111-06	nelarabine	50 mL in 1 VIAL, SINGLE-DOSE	INJECTION	50	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
81927-111-01	ML - Milliliter	81927-111	20d83d4b-121a-47a7-8849-2af2bfc8262f	1	2023-04-07
81927-111-06	ML - Milliliter	81927-111	30d65b67-7d05-4706-9046-0ff64416ce6a	1	2023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
81927-111	NELARABINE INJECTION [SHORLA ONCOLOGY INC.]	3	Current NDC, 4 package rows	20250430_fc401b06-4e3b-413e-a854-3e031c433862.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
nelarabine	NELARABINE	Shorla Oncology Inc.	fc401b06-4e3b-413e-a854-3e031c433862	2025-07-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214809 application number: ANDA214809 ndc (package): 81927-111-06 ndc (product): 81927-111 ndc11 (package): 81927011106

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
603566	nelarabine 250 MG in 50 ML Injection	PSN	fc401b06-4e3b-413e-a854-3e031c433862	6
2722411	nelarabine 375 MG in 75 ML Injection	PSN	fc401b06-4e3b-413e-a854-3e031c433862	6
603566	50 ML nelarabine 5 MG/ML Injection	SCD	fc401b06-4e3b-413e-a854-3e031c433862	6
2722411	75 ML nelarabine 5 MG/ML Injection	SCD	fc401b06-4e3b-413e-a854-3e031c433862	6
603566	nelarabine 250 MG per 50 ML Injection	SY	fc401b06-4e3b-413e-a854-3e031c433862	6
2722411	nelarabine 375 MG per 75 ML Injection	SY	fc401b06-4e3b-413e-a854-3e031c433862	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
81927-111-06	81927011106	6 VIAL, SINGLE-DOSE in 1 CARTON (81927-111-06) / 50 mL in 1 VIAL, SINGLE-DOSE	2023-03-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
nelarabine	Shorla Oncology Inc. \| Shorla Pharma Ltd. \| AqVida GmbH	2025-07-23	HUMAN PRESCRIPTION DRUG LABEL	6