Carboplatin

Product NDC: 63323-172
Requested package NDC: 63323-172-60
11-digit product format: 633230172
Labeler code: 63323
Product ID: 63323-172_3a1dd588-13b0-4d58-8d46-3a25a4fc6b40
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CARBOPLATIN
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Fresenius Kabi USA, LLC
Application: ANDA077266
Marketing category: ANDA
Marketing start: 2009-12-11
Substance: CARBOPLATIN
Active strength: 10 mg/mL
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 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A077266-001	CARBOPLATIN	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS		2006-02-15
A077266-002	CARBOPLATIN	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS		2006-02-15
A077266-003	CARBOPLATIN	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2006-02-15
A077266-004	CARBOPLATIN	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2006-02-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A077266-003	AP
A077266-004	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 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077266-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS		2006-02-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077266-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS		2006-02-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077266-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2006-02-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077266-004	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2006-02-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077266-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS		2006-02-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077266-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS		2006-02-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077266-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2006-02-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077266-004	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2006-02-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077266-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS		2006-02-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077266-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS		2006-02-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077266-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2006-02-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077266-004	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2006-02-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077266-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS		2006-02-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077266-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS		2006-02-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077266-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2006-02-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077266-004	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2006-02-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077266-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS		2006-02-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077266-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS		2006-02-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077266-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2006-02-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077266-004	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2006-02-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077266-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS		2006-02-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077266-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS		2006-02-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077266-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2006-02-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077266-004	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2006-02-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077266-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS		2006-02-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077266-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS		2006-02-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077266-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2006-02-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077266-004	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2006-02-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077266-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS		2006-02-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077266-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS		2006-02-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077266-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2006-02-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077266-004	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2006-02-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077266-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS		2006-02-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077266-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS		2006-02-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077266-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2006-02-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077266-004	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2006-02-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077266-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS		2006-02-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077266-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS		2006-02-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077266-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2006-02-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077266-004	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	2006-02-15	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A077266-003	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077266-004	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077266-003	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077266-004	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077266-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077266-004	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077266-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077266-004	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077266-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077266-004	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077266-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077266-004	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077266-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077266-004	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077266-003	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077266-004	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077266-003	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077266-004	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077266-003	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077266-004	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077266-003	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077266-004	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077266-003	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077266-004	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077266-003	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077266-004	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077266-003	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077266-004	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077266-003	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077266-004	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077266-003	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077266-004	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077266-003	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077266-004	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077266-003	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077266-004	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077266-003	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077266-004	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077266-003	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077266-004	AP	1	`74a2ff9319b5…`

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: Carboplatin
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CARBOPLATIN	10 mg/mL

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
597195	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
b4fa7aac-c9d2-4af4-a281-3e6cfc502ff6	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
63323-172-60	Carboplatin	60 mL in 1 VIAL	INJECTION, SOLUTION	60		4
63323-172-60	Carboplatin	1 in 1 BOX	INJECTION, SOLUTION	1		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63323-172-05	ML - Milliliter	63323-172	cb987630-190a-4676-8d26-6605490fada0	1	2012-07-24
63323-172-15	ML - Milliliter	63323-172	426aa91e-aa4f-4c51-a1ef-0403c1fc1691	1	2012-07-24
63323-172-45	ML - Milliliter	63323-172	8f9c9de2-6c81-432f-8c19-cf2382836039	1	2012-07-24
63323-172-60	ML - Milliliter	63323-172	b597082a-b6f1-4f3b-b3aa-053c0a516794	1	2017-07-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CARBOPLATIN	ACTIVE INGREDIENT	BG3F62OND5	CARBOPLATIN INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]	3
CARBOPLATIN	ACTIVE MOIETY	BG3F62OND5	CARBOPLATIN INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	CARBOPLATIN INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63323-172	CARBOPLATIN (CARBOPLATIN) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	4	Current NDC, Legacy NDC, 2 package rows	20211110_b4fa7aac-c9d2-4af4-a281-3e6cfc502ff6.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
Carboplatin	CARBOPLATIN	Fresenius Kabi USA, LLC	b4fa7aac-c9d2-4af4-a281-3e6cfc502ff6	2021-07-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077266 application number: ANDA077266 ndc (package): 63323-172-60 ndc (product): 63323-172 ndc11 (package): 63323017260

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	b4fa7aac-c9d2-4af4-a281-3e6cfc502ff6	4
597195	carboplatin 10 MG/ML Injectable Solution	SCD	b4fa7aac-c9d2-4af4-a281-3e6cfc502ff6	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63323-172-60	63323017260	1 VIAL in 1 BOX (63323-172-60) / 60 mL in 1 VIAL	1 vial	2009-12-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CARBOplatin Injection	Fresenius Kabi USA, LLC	2021-07-07	HUMAN PRESCRIPTION DRUG LABEL	4
CARBOPLATIN INJECTION Rx only	Fresenius Kabi USA, LLC \| Cipla Ltd.	2019-09-11	HUMAN PRESCRIPTION DRUG LABEL	6
Fresenius Kabi USA, LLC \| CIPLA LIMITED \| Fresenius Kabi Oncology Limited blanket no changes certification of product listing	Fresenius Kabi USA, LLC \| CIPLA LIMITED \| Fresenius Kabi Oncology Limited	2017-10-11	BLANKET NO CHANGES CERTIFICATION OF PRODUCT LISTING	1