KYXATA

Product NDC: 83831-141
11-digit product format: 838310141
Labeler code: 83831
Product ID: 83831-141_5c711945-70be-42f4-b153-e1459dd9929c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CARBOplatin
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Avyxa Pharma, LLC
Application: NDA219921
Marketing category: NDA
Marketing start: 2025-09-10
Substance: CARBOPLATIN
Active strength: 80 mg/8mL
Pharmacologic classes: Platinum-based Drug [EPC], Platinum-containing Compounds [EXT]
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 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N219921-001	KYXATA	CARBOPLATIN	20MG/2ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD	2025-08-08
N219921-002	KYXATA	CARBOPLATIN	80MG/8ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2025-08-08
N219921-003	KYXATA	CARBOPLATIN	500MG/50ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2025-08-08

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N219921-001	12427104	2045-04-01	Drug product	2025-10-02
N219921-002	12427104	2045-04-01	Drug product	2025-10-02
N219921-003	12427104	2045-04-01	Drug product	2025-10-02

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N219921-001	KYXATA	20MG/2ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD	2025-08-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219921-002	KYXATA	80MG/8ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2025-08-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219921-003	KYXATA	500MG/50ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2025-08-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N219921-001	KYXATA	20MG/2ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD	2025-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219921-002	KYXATA	80MG/8ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2025-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219921-003	KYXATA	500MG/50ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2025-08-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219921-001	KYXATA	20MG/2ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD	2025-08-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219921-002	KYXATA	80MG/8ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2025-08-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219921-003	KYXATA	500MG/50ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2025-08-08	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219921-001	KYXATA	20MG/2ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD	2025-08-08	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219921-002	KYXATA	80MG/8ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2025-08-08	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219921-003	KYXATA	500MG/50ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2025-08-08	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N219921-001	12427104	2045-04-01	Drug product	2025-10-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219921-002	12427104	2045-04-01	Drug product	2025-10-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219921-003	12427104	2045-04-01	Drug product	2025-10-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N219921-001	12427104	2045-04-01	Drug product	2025-10-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219921-002	12427104	2045-04-01	Drug product	2025-10-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219921-003	12427104	2045-04-01	Drug product	2025-10-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219921-001	12427104	2045-04-01	Drug product	2025-10-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219921-002	12427104	2045-04-01	Drug product	2025-10-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219921-003	12427104	2045-04-01	Drug product	2025-10-02	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219921-001	12427104	2045-04-01	Drug product	2025-10-02	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219921-002	12427104	2045-04-01	Drug product	2025-10-02	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219921-003	12427104	2045-04-01	Drug product	2025-10-02	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: KYXATA
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CARBOPLATIN	80 mg/8mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
BG3F62OND5	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
597195	Internal RxNorm lookup
2721602	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
f91c48da-68d1-4aa7-89b8-d84a3e8b629b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bc5428ef-b189-45ae-a76c-39765d009ff4	Product name	3	20170502

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
83831-141-08	KYXATA	8 mL in 1 VIAL, MULTI-DOSE	INJECTION	8		6
83831-141-08	KYXATA	1 in 1 CARTON	INJECTION	1		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
83831-141-08	ML - Milliliter	83831-141	c1424313-8104-439a-99d8-7e0b67b19168	1	2025-09-12

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
KYXATA	CARBOPLATIN	Avyxa Pharma, LLC	f91c48da-68d1-4aa7-89b8-d84a3e8b629b	2025-09-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 219921 application number: NDA219921 ndc (product): 83831-141

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
BG3F62OND5	CARBOPLATIN	41575-94-4	CARBOPLATIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
597195	CARBOplatin 10 MG/ML Injectable Solution	PSN	f91c48da-68d1-4aa7-89b8-d84a3e8b629b	6
2721602	KYXATA 10 MG/ML Injectable Solution	PSN	f91c48da-68d1-4aa7-89b8-d84a3e8b629b	6
2721602	carboplatin 10 MG/ML Injectable Solution [Kyxata]	SBD	f91c48da-68d1-4aa7-89b8-d84a3e8b629b	6
597195	carboplatin 10 MG/ML Injectable Solution	SCD	f91c48da-68d1-4aa7-89b8-d84a3e8b629b	6
2721602	Kyxata 20 MG per 2 ML Injectable Solution	SY	f91c48da-68d1-4aa7-89b8-d84a3e8b629b	6
2721602	Kyxata 500 MG per 50 ML Injectable Solution	SY	f91c48da-68d1-4aa7-89b8-d84a3e8b629b	6
2721602	Kyxata 80 MG per 8 ML Injectable Solution	SY	f91c48da-68d1-4aa7-89b8-d84a3e8b629b	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
83831-141-08	83831014108	1 VIAL, MULTI-DOSE in 1 CARTON (83831-141-08) / 8 mL in 1 VIAL, MULTI-DOSE	2025-09-10	No	No	Current