PARAPLATIN

Product NDC: 69448-005
11-digit product format: 694480005
Labeler code: 69448
Product ID: 69448-005_e69a06ea-e917-25ea-e053-2995a90a6f6f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Carboplatin
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Accord BioPharma Inc.
Application: ANDA206775
Marketing category: ANDA
Marketing start: 2020-02-12
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	69448-005		D	Discontinued by firm	2026-08-17
excluded package	package	69448-005	69448-005-12	D	Discontinued by firm	2026-08-17
excluded package	package	69448-005	69448-005-31	D	Discontinued by firm	2026-08-17
excluded package	package	69448-005	69448-005-33	D	Discontinued by firm	2026-08-17
excluded package	package	69448-005	69448-005-34	D	Discontinued by firm	2026-08-17
excluded package	package	69448-005	69448-005-38	D	Discontinued by firm	2026-08-17

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 · 50 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69448-005-31	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69448-005-38	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69448-005-34	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69448-005-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69448-005-33	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69448-005-34	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69448-005-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69448-005-33	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69448-005-31	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69448-005-34	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69448-005-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69448-005-33	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69448-005-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69448-005-34	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69448-005-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69448-005-33	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69448-005-31	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69448-005-34	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69448-005-12	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69448-005-33	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69448-005-31	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69448-005-34	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69448-005-12	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69448-005-33	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69448-005-31	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69448-005-34	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69448-005-12	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69448-005-33	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69448-005-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69448-005-34	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69448-005-12	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69448-005-33	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69448-005-31	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69448-005-34	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69448-005-12	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69448-005-33	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69448-005-31	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69448-005-34	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69448-005-12	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69448-005-33	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69448-005-31	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69448-005-34	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69448-005-12	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69448-005-33	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69448-005-31	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69448-005-34	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69448-005-12	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69448-005-33	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69448-005-31	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A206775-001	CARBOPLATIN	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP		2017-02-09
A206775-002	CARBOPLATIN	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP		2017-02-09
A206775-003	CARBOPLATIN	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP		2017-02-09
A206775-004	CARBOPLATIN	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP		2017-02-09
A206775-005	CARBOPLATIN	CARBOPLATIN	1GM/100ML (10MG/ML)	INJECTABLE / INTRAVENOUS		RS	2020-04-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A206775-001	AP
A206775-002	AP
A206775-003	AP
A206775-004	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 6 · 206 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
2026-08-18 06:07:40	2026-07	A206775-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP		2017-02-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206775-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP		2017-02-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206775-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP		2017-02-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206775-004	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP		2017-02-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206775-005	CARBOPLATIN	1GM/100ML (10MG/ML)	INJECTABLE / INTRAVENOUS		RS	2020-04-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206775-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP		2017-02-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206775-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP		2017-02-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206775-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP		2017-02-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206775-004	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP		2017-02-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206775-005	CARBOPLATIN	1GM/100ML (10MG/ML)	INJECTABLE / INTRAVENOUS		RS	2020-04-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206775-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP		2017-02-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206775-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP		2017-02-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206775-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP		2017-02-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206775-004	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP		2017-02-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206775-005	CARBOPLATIN	1GM/100ML (10MG/ML)	INJECTABLE / INTRAVENOUS		RS	2020-04-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206775-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP		2017-02-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206775-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP		2017-02-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206775-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP		2017-02-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206775-004	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP		2017-02-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206775-005	CARBOPLATIN	1GM/100ML (10MG/ML)	INJECTABLE / INTRAVENOUS		RS	2020-04-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206775-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP		2017-02-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206775-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP		2017-02-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206775-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP		2017-02-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206775-004	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP		2017-02-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206775-005	CARBOPLATIN	1GM/100ML (10MG/ML)	INJECTABLE / INTRAVENOUS		RS	2020-04-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206775-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP		2017-02-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206775-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP		2017-02-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206775-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP		2017-02-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206775-004	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP		2017-02-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206775-005	CARBOPLATIN	1GM/100ML (10MG/ML)	INJECTABLE / INTRAVENOUS		RS	2020-04-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206775-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP		2017-02-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206775-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP		2017-02-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206775-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP		2017-02-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206775-004	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP		2017-02-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206775-005	CARBOPLATIN	1GM/100ML (10MG/ML)	INJECTABLE / INTRAVENOUS		RS	2020-04-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206775-001	CARBOPLATIN	50MG/5ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP		2017-02-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206775-002	CARBOPLATIN	150MG/15ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP		2017-02-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206775-003	CARBOPLATIN	450MG/45ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP		2017-02-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206775-004	CARBOPLATIN	600MG/60ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP		2017-02-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206775-005	CARBOPLATIN	1GM/100ML (10MG/ML)	INJECTABLE / INTRAVENOUS		RS	2020-04-06	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A206775-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206775-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206775-003	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206775-004	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206775-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206775-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206775-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206775-004	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206775-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206775-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206775-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206775-004	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206775-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206775-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206775-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206775-004	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206775-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206775-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206775-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206775-004	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206775-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206775-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206775-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206775-004	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206775-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206775-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206775-003	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206775-004	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206775-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206775-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206775-003	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206775-004	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206775-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206775-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206775-003	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206775-004	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206775-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206775-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206775-003	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206775-004	AP	1	`d8e5a09893c0…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69448-005-12	ML - Milliliter	69448-005	03ac42fc-3c44-4bcd-a0bf-26fb3e8d129b	1	2020-03-10
69448-005-33	ML - Milliliter	69448-005	f4345c5e-089d-41bf-9bea-c5782a298383	1	2020-03-10
69448-005-34	ML - Milliliter	69448-005	870aa1b3-5b46-442c-b72d-5f86ad5191e3	1	2020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69448-005	PARAPLATIN (CARBOPLATIN) INJECTION [ACCORD BIOPHARMA INC.]	4	Legacy NDC	20220820_f88e0483-09be-4f60-be8f-964c02e3ece0.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	Accord Healthcare, Inc.	48aa7ef3-9f44-2a08-e054-00144ff88e88	2025-05-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206775 application number: ANDA206775

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	Marketing start	Marketing end	Sample	Exclude flag	Status
69448-005-12	69448000512	1 VIAL, MULTI-DOSE in 1 CARTON (69448-005-12) > 60 mL in 1 VIAL, MULTI-DOSE	2020-02-12	0000-00-00	No	No	Current
69448-005-31	69448000531	1 VIAL, MULTI-DOSE in 1 CARTON (69448-005-31) > 5 mL in 1 VIAL, MULTI-DOSE	2020-02-12	0000-00-00	No	No	Current
69448-005-33	69448000533	1 VIAL, MULTI-DOSE in 1 CARTON (69448-005-33) > 15 mL in 1 VIAL, MULTI-DOSE	2020-02-12	0000-00-00	No	No	Current
69448-005-34	69448000534	1 VIAL, MULTI-DOSE in 1 CARTON (69448-005-34) > 45 mL in 1 VIAL, MULTI-DOSE	2020-02-12	0000-00-00	No	No	Current
69448-005-38	69448000538	1 VIAL, MULTI-DOSE in 1 CARTON (69448-005-38) > 100 mL in 1 VIAL, MULTI-DOSE	2020-08-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PARAPLATIN ® (carboplatin) Injection Rx only	Accord BioPharma Inc. \| Accord Healthcare Inc. \| Intas Pharmaceuticals Limited	2022-08-19	HUMAN PRESCRIPTION DRUG LABEL	4