fosaprepitant

Product NDC: 67457-888
11-digit product format: 674570888
Labeler code: 67457
Product ID: 67457-888_65e4e7f1-6ca9-4138-ad88-38f530abac3b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: fosaprepitant
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Mylan Institutional LLC
Application: ANDA204015
Marketing category: ANDA
Marketing start: 2019-09-05
Marketing end: 0000-00-00
Substance: FOSAPREPITANT DIMEGLUMINE
Active strength: 115 mg/5mL
Pharmacologic classes: Neurokinin 1 Antagonists [MoA],Substance P/Neurokinin-1 Receptor Antagonist [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 3A4 Inducers [MoA]
NDC exclude flag: No
Listing certified through: 2021-12-31
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 product	product	67457-888		D	Discontinued by firm		2026-08-07

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 · 15 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
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
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	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

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

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
A204015-001	FOSAPREPITANT DIMEGLUMINE	FOSAPREPITANT DIMEGLUMINE	EQ 115MG BASE/VIAL	POWDER / INTRAVENOUS			2019-09-05
A204015-002	FOSAPREPITANT DIMEGLUMINE	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP		2019-09-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204015-002	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 2 · 80 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
2026-02-19 14:30 UTC	2026-02	A204015-001	FOSAPREPITANT DIMEGLUMINE	EQ 115MG BASE/VIAL	POWDER / INTRAVENOUS		2019-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204015-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204015-001	FOSAPREPITANT DIMEGLUMINE	EQ 115MG BASE/VIAL	POWDER / INTRAVENOUS		2019-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204015-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204015-001	FOSAPREPITANT DIMEGLUMINE	EQ 115MG BASE/VIAL	POWDER / INTRAVENOUS		2019-09-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204015-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204015-001	FOSAPREPITANT DIMEGLUMINE	EQ 115MG BASE/VIAL	POWDER / INTRAVENOUS		2019-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204015-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204015-001	FOSAPREPITANT DIMEGLUMINE	EQ 115MG BASE/VIAL	POWDER / INTRAVENOUS		2019-09-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204015-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204015-001	FOSAPREPITANT DIMEGLUMINE	EQ 115MG BASE/VIAL	POWDER / INTRAVENOUS		2019-09-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204015-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204015-001	FOSAPREPITANT DIMEGLUMINE	EQ 115MG BASE/VIAL	POWDER / INTRAVENOUS		2019-09-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204015-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204015-001	FOSAPREPITANT DIMEGLUMINE	EQ 115MG BASE/VIAL	POWDER / INTRAVENOUS		2019-09-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204015-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204015-001	FOSAPREPITANT DIMEGLUMINE	EQ 115MG BASE/VIAL	POWDER / INTRAVENOUS		2019-09-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204015-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204015-001	FOSAPREPITANT DIMEGLUMINE	EQ 115MG BASE/VIAL	POWDER / INTRAVENOUS		2019-09-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204015-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204015-001	FOSAPREPITANT DIMEGLUMINE	EQ 115MG BASE/VIAL	POWDER / INTRAVENOUS		2019-09-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204015-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204015-001	FOSAPREPITANT DIMEGLUMINE	EQ 115MG BASE/VIAL	POWDER / INTRAVENOUS		2019-09-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204015-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204015-001	FOSAPREPITANT DIMEGLUMINE	EQ 115MG BASE/VIAL	POWDER / INTRAVENOUS		2019-09-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204015-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204015-001	FOSAPREPITANT DIMEGLUMINE	EQ 115MG BASE/VIAL	POWDER / INTRAVENOUS		2019-09-05	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204015-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204015-001	FOSAPREPITANT DIMEGLUMINE	EQ 115MG BASE/VIAL	POWDER / INTRAVENOUS		2019-09-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204015-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204015-001	FOSAPREPITANT DIMEGLUMINE	EQ 115MG BASE/VIAL	POWDER / INTRAVENOUS		2019-09-05	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204015-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204015-001	FOSAPREPITANT DIMEGLUMINE	EQ 115MG BASE/VIAL	POWDER / INTRAVENOUS		2019-09-05	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204015-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204015-001	FOSAPREPITANT DIMEGLUMINE	EQ 115MG BASE/VIAL	POWDER / INTRAVENOUS		2019-09-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204015-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204015-001	FOSAPREPITANT DIMEGLUMINE	EQ 115MG BASE/VIAL	POWDER / INTRAVENOUS		2019-09-05	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204015-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204015-001	FOSAPREPITANT DIMEGLUMINE	EQ 115MG BASE/VIAL	POWDER / INTRAVENOUS		2019-09-05	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204015-002	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2019-09-05	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204015-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204015-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204015-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204015-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204015-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204015-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204015-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204015-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204015-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204015-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204015-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204015-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204015-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204015-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204015-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204015-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204015-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204015-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204015-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204015-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204015-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204015-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204015-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204015-002	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204015-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204015-002	AP	1	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204015-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204015-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204015-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204015-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204015-002	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204015-002	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204015-002	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204015-002	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204015-002	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204015-002	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204015-002	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204015-002	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204015-002	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A204015-002	AP	1	`a50c72e98297…`

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2025-07-16	These highlights do not include all the information needed to use FOSAPREPITANT FOR INJECTION safely and effectively. See full prescribing information for FOSAPREPITANT FOR INJECTION . FOSAPREPITANT for injection, for intravenous use Initial U.S. Approval: 2008
2025-07-16	These highlights do not include all the information needed to use FOSAPREPITANT FOR INJECTION safely and effectively. See full prescribing information for FOSAPREPITANT FOR INJECTION . FOSAPREPITANT for injection, for intravenous use Initial U.S. Approval: 2008
2023-01-30	These highlights do not include all the information needed to use FOSAPREPITANT FOR INJECTION safely and effectively. See full prescribing information for FOSAPREPITANT FOR INJECTION . FOSAPREPITANT for injection, for intravenous use Initial U.S. Approval: 2008
2023-01-30	These highlights do not include all the information needed to use FOSAPREPITANT FOR INJECTION safely and effectively. See full prescribing information for FOSAPREPITANT FOR INJECTION . FOSAPREPITANT for injection, for intravenous use Initial U.S. Approval: 2008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67457-888	FOSAPREPITANT INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC]	2	Legacy NDC	20200404_9b6d5ea3-2f7a-4501-9a4a-6fa1a7c2d50a.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
fosaprepitant	FOSAPREPITANT	Mylan Institutional LLC	9b6d5ea3-2f7a-4501-9a4a-6fa1a7c2d50a	2026-04-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204015 application number: ANDA204015

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
D35FM8T64X	FOSAPREPITANT DIMEGLUMINE	265121-04-8	FOSAPREPITANT DIMEGLUMINE
6L8OF9XRDC	FOSAPREPITANT	172673-20-0	fosaprepitant