Carboplatin

Product NDC: 71288-100
Requested package NDC: 71288-100-05
11-digit product format: 712880100
Labeler code: 71288
Product ID: 71288-100_d5b09a1b-a45b-44d4-abde-26faf80dd09b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Carboplatin
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Meitheal Pharmaceuticals Inc.
Application: ANDA077096
Marketing category: ANDA
Marketing start: 2017-06-19
Marketing end: 0000-00-00
Substance: CARBOPLATIN
Active strength: 10 mg/mL
Pharmacologic classes: Platinum-based Drug [EPC], Platinum-containing Compounds [EXT]
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	71288-100	71288-100-05	D	Discontinued by firm		2026-08-10

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	Approval date
A077096-001	CARBOPLATIN	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2005-06-14
A077096-002	CARBOPLATIN	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2005-06-14
A077096-003	CARBOPLATIN	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2005-06-14
A077096-004	CARBOPLATIN	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2013-06-03

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 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077096-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2005-06-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077096-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2005-06-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077096-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2005-06-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077096-004	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2013-06-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077096-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2005-06-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077096-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2005-06-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077096-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2005-06-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077096-004	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2013-06-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077096-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2005-06-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077096-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2005-06-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077096-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2005-06-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077096-004	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2013-06-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077096-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2005-06-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077096-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2005-06-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077096-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2005-06-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077096-004	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2013-06-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077096-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2005-06-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077096-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2005-06-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077096-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2005-06-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077096-004	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2013-06-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077096-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2005-06-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077096-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2005-06-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077096-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2005-06-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077096-004	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2013-06-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077096-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2005-06-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077096-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2005-06-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077096-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2005-06-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077096-004	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2013-06-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077096-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2005-06-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077096-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2005-06-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077096-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2005-06-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077096-004	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2013-06-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077096-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2005-06-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077096-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2005-06-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077096-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2005-06-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077096-004	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2013-06-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077096-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2005-06-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077096-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2005-06-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077096-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2005-06-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077096-004	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	2013-06-03	`d06236e962d9…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A077096-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077096-002	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077096-003	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077096-004	AP	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077096-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077096-002	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077096-003	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077096-004	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077096-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077096-002	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077096-003	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077096-004	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077096-001	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077096-002	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077096-003	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077096-004	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077096-001	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077096-002	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077096-003	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077096-004	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077096-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077096-002	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077096-003	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077096-004	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077096-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077096-002	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077096-003	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077096-004	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077096-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077096-002	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077096-003	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077096-004	AP	1	`ea99ee380514…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
71288-100-05	2025-12-18	Carboplatin Injection (carboplatin aqueous solution)
71288-100-15	2025-12-18	Carboplatin Injection (carboplatin aqueous solution)
71288-100-45	2025-12-18	Carboplatin Injection (carboplatin aqueous solution)
71288-100-51	2025-12-18	Carboplatin Injection (carboplatin aqueous solution)
71288-100-05	2024-01-30	Carboplatin Injection (carboplatin aqueous solution)
71288-100-15	2024-01-30	Carboplatin Injection (carboplatin aqueous solution)
71288-100-45	2024-01-30	Carboplatin Injection (carboplatin aqueous solution)
71288-100-51	2024-01-30	Carboplatin Injection (carboplatin aqueous solution)

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71288-100-05	ML - Milliliter	71288-100	988bec11-f386-4634-84d5-9ea7b73f5c96	1	2017-10-13
71288-100-15	ML - Milliliter	71288-100	2d3ec57e-e46e-445b-b8cd-ea526701e3ac	1	2017-10-13
71288-100-45	ML - Milliliter	71288-100	4781f76c-524b-43c7-b4ff-d84449eae56b	1	2017-10-13
71288-100-51	ML - Milliliter	71288-100	18362a8e-daf0-4cb0-acb1-63b9f9eeb3f8	1	2017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71288-100	CARBOPLATIN INJECTION, SOLUTION [MEITHEAL PHARMACEUTICALS INC.]	3	Legacy NDC	20221203_81757808-f609-40d1-a4c1-08b32234719f.zip

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71288-100-05	71288010005	1 VIAL in 1 CARTON (71288-100-05) > 5 mL in 1 VIAL	1 vial	2017-06-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Carboplatin Injection (carboplatin aqueous solution)	Meitheal Pharmaceuticals Inc.	2022-12-02	HUMAN PRESCRIPTION DRUG LABEL	3