fosaprepitant

Product NDC: 67457-889
11-digit product format: 674570889
Labeler code: 67457
Product ID: 67457-889_69d27b25-c8a3-434c-891d-7d5c1c495e3d
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
Substance: FOSAPREPITANT DIMEGLUMINE
Active strength: 150 mg/5mL
Pharmacologic classes: Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Neurokinin 1 Antagonists [MoA], Substance P/Neurokinin-1 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: fosaprepitant
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FOSAPREPITANT DIMEGLUMINE	150 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
D35FM8T64X	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1731077	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
9b6d5ea3-2f7a-4501-9a4a-6fa1a7c2d50a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
2abc3e32-ae1f-4dec-be1c-0c39ac95b38e	Product name	7	20240514
5d352eda-d4de-4572-9a3f-32d6fd204f9a	Product name	1	20230911
3a5d67cc-4a03-45a3-8d74-5aeb67631be4	Product name	1	20230831
85fc66a9-58b2-e194-7cdb-89ff44dcf3e6	Product name	4	20210518
9f9a82fd-fcee-442f-9233-7f2d2f9f4568	Product name	1	20180108

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67457-889-10	fosaprepitant	5 mL in 1 VIAL, SINGLE-DOSE	INJECTION, POWDER, LYOPHILIZED,	5		4
67457-889-10	fosaprepitant	1 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	1		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67457-889-10	EA - Each	67457-889	0d4fbb58-6610-492b-bffc-87c4dc0fc8f1	1	2019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67457-889	FOSAPREPITANT INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC]	2	Current NDC, Legacy NDC, 2 package rows	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 ndc (product): 67457-889

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1731077	fosaprepitant 150 MG Injection	PSN	9b6d5ea3-2f7a-4501-9a4a-6fa1a7c2d50a	4
1731077	fosaprepitant 150 MG Injection	SCD	9b6d5ea3-2f7a-4501-9a4a-6fa1a7c2d50a	4
1731077	fosaprepitant 150 MG (as fosaprepitant dimeglumine 245.3 MG) Injection	SY	9b6d5ea3-2f7a-4501-9a4a-6fa1a7c2d50a	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
67457-889-10	67457088910	1 VIAL, SINGLE-DOSE in 1 CARTON (67457-889-10) / 5 mL in 1 VIAL, SINGLE-DOSE	2019-09-05	0000-00-00	No	No	Current