EMEND

Product NDC: 0006-3941
11-digit product format: 000063941
Labeler code: 0006
Product ID: 0006-3941_46054db2-5cc3-4a8d-86a3-f11f687f3d30
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: FOSAPREPITANT DIMEGLUMINE
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Merck Sharp & Dohme Corp.
Application: NDA022023
Marketing category: NDA
Marketing start: 2010-11-12
Marketing end: 0000-00-00
Substance: FOSAPREPITANT DIMEGLUMINE
Active strength: 150 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: 2019-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0006-3941		I	Inactivated by FDA		2026-08-17
excluded package	package	0006-3941	0006-3941-32	I	Inactivated by FDA		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 · 42 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	0006-3941-32	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0006-3941-32	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0006-3941-32	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0006-3941-32	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0006-3941-32	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0006-3941-32	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0006-3941-32	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0006-3941-32	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0006-3941-32	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0006-3941-32	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0006-3941-32	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0006-3941-32	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	0006-3941-32	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	0006-3941-32	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	0006-3941-32	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	0006-3941-32	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	0006-3941-32	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	0006-3941-32	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	0006-3941-32	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	0006-3941-32	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	0006-3941-32	`9bebd1f3094a…`	`5416666fcb17…`

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

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
N022023-001	EMEND	FOSAPREPITANT DIMEGLUMINE	EQ 115MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	2008-01-25
N022023-002	EMEND	FOSAPREPITANT DIMEGLUMINE	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2010-11-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N022023-002	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 3 · 84 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	N022023-001	EMEND	EQ 115MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	2008-01-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022023-002	EMEND	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2010-11-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022023-001	EMEND	EQ 115MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	2008-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022023-002	EMEND	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2010-11-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022023-001	EMEND	EQ 115MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	2008-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022023-002	EMEND	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2010-11-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022023-001	EMEND	EQ 115MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	2008-01-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022023-002	EMEND	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2010-11-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022023-001	EMEND	EQ 115MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	2008-01-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022023-002	EMEND	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2010-11-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022023-001	EMEND	EQ 115MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	2008-01-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022023-002	EMEND	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2010-11-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022023-001	EMEND	EQ 115MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	2008-01-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022023-002	EMEND	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2010-11-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022023-001	EMEND	EQ 115MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	2008-01-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022023-002	EMEND	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2010-11-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022023-001	EMEND	EQ 115MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	2008-01-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022023-002	EMEND	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2010-11-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022023-001	EMEND	EQ 115MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	2008-01-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022023-002	EMEND	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2010-11-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022023-001	EMEND	EQ 115MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	2008-01-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022023-002	EMEND	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2010-11-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022023-001	EMEND	EQ 115MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	2008-01-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022023-002	EMEND	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2010-11-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022023-001	EMEND	EQ 115MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	2008-01-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022023-002	EMEND	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2010-11-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022023-001	EMEND	EQ 115MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	2008-01-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022023-002	EMEND	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2010-11-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022023-001	EMEND	EQ 115MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	2008-01-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022023-002	EMEND	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2010-11-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022023-001	EMEND	EQ 115MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	2008-01-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022023-002	EMEND	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2010-11-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022023-001	EMEND	EQ 115MG BASE/VIAL	POWDER / INTRAVENOUS		RLD	2008-01-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022023-002	EMEND	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2010-11-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022023-001	EMEND	EQ 115MG BASE/VIAL	POWDER / INTRAVENOUS		RLD	2008-01-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022023-002	EMEND	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2010-11-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022023-001	EMEND	EQ 115MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	POWDER / INTRAVENOUS		RLD	2008-01-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022023-002	EMEND	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2010-11-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022023-001	EMEND	EQ 115MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	2008-01-25	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022023-002	EMEND	EQ 150MG BASE/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2010-11-12	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	N022023-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022023-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022023-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022023-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022023-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022023-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022023-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022023-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022023-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022023-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022023-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022023-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022023-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022023-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022023-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022023-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022023-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022023-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022023-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022023-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022023-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022023-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022023-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022023-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022023-002	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022023-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022023-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022023-002	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022023-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022023-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022023-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022023-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022023-002	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022023-002	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022023-002	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022023-002	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022023-002	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022023-002	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022023-002	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022023-002	AP	1	`e64feba35796…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022023-001	5691336	2019-03-04		Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022023-001	5691336*PED	2019-09-04		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022023-002	5691336	2019-03-04	U-2265	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022023-002	5691336*PED	2019-09-04		Pediatric extension	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N022023-001	5691336	2019-03-04		Drug substance, Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022023-001	5691336*PED	2019-09-04		Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022023-002	5691336	2019-03-04	U-2265	Drug substance, Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022023-002	5691336*PED	2019-09-04		Pediatric extension	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022023-001	5691336	2019-03-04		Drug substance, Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022023-001	5691336*PED	2019-09-04		Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022023-002	5691336	2019-03-04	U-2265	Drug substance, Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022023-002	5691336*PED	2019-09-04		Pediatric extension	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022023-001	5691336	2019-03-04		Drug substance, Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022023-001	5691336*PED	2019-09-04		Pediatric extension	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022023-002	5691336	2019-03-04	U-2265	Drug substance, Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022023-002	5691336*PED	2019-09-04		Pediatric extension	`ea99ee380514…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 92 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022023-001	D-186	2025-05-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022023-002	D-186	2025-05-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022023-001	D-186	2025-05-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022023-002	D-186	2025-05-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022023-001	D-186	2025-05-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022023-002	D-186	2025-05-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022023-001	D-186	2025-05-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022023-002	D-186	2025-05-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022023-001	D-186	2025-05-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022023-002	D-186	2025-05-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022023-001	D-186	2025-05-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022023-002	D-186	2025-05-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022023-001	D-186	2025-05-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022023-002	D-186	2025-05-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022023-001	D-186	2025-05-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022023-002	D-186	2025-05-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022023-001	D-186	2025-05-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022023-002	D-186	2025-05-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022023-001	D-186	2025-05-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022023-002	D-186	2025-05-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022023-001	D-186	2025-05-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022023-002	D-186	2025-05-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022023-001	D-186	2025-05-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022023-002	D-186	2025-05-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022023-001	D-186	2025-05-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022023-002	D-186	2025-05-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022023-001	D-186	2025-05-02	`5c6f7cd8ea54…`
2019-12-13 00:20 UTC	2019-12	N022023-001	NPP	2021-04-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022023-001	PED	2021-10-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022023-002	D-155	2019-02-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022023-002	NPP	2021-04-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022023-002	PED	2021-10-03	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N022023-001	NPP	2021-04-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022023-001	PED	2021-10-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022023-002	NPP	2021-04-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022023-002	PED	2021-10-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022023-001	NPP	2021-04-03	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022023-001	PED	2021-10-03	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022023-002	NPP	2021-04-03	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022023-002	PED	2021-10-03	`87673890dc5c…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0006-3941-32	2020-01-31	C162847	48780-1	9d75b9d0-7d2c-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use EMEND FOR INJECTION safely and effectively. See full prescribing information for EMEND FOR INJECTION. EMEND (fosaprepitant) for injection, for intravenous use Initial U.S. Approval: 2008

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0006-3941-01	EMEND	5 mL in 1 VIAL, SINGLE-DOSE	INJECTION, POWDER, LYOPHILIZED,	5		30
0006-3941-32	EMEND	1 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	1		30

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0006-3941-01	EA - Each	0006-3941	d0df5dfc-d5a5-4cf4-a773-d5b771c7e165	1	2015-05-05
0006-3941-32	EA - Each	0006-3941	977b6998-2bd0-4c50-bfb6-d64e2e8d54f1	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FOSAPREPITANT DIMEGLUMINE	ACTIVE INGREDIENT	D35FM8T64X	EMEND (FOSAPREPITANT DIMEGLUMINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]	22
APREPITANT	ACTIVE MOIETY	1NF15YR6UY	EMEND (FOSAPREPITANT DIMEGLUMINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]	22
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	EMEND (FOSAPREPITANT DIMEGLUMINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]	22
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	EMEND (FOSAPREPITANT DIMEGLUMINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]	22
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	EMEND (FOSAPREPITANT DIMEGLUMINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]	22
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	EMEND (FOSAPREPITANT DIMEGLUMINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]	22
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	EMEND (FOSAPREPITANT DIMEGLUMINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]	22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0006-3941	EMEND (FOSAPREPITANT DIMEGLUMINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]	30	Legacy NDC, 2 package rows	20180404_44f634f4-b794-4d55-8ab7-037fdef8ff0f.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
EMEND	FOSAPREPITANT DIMEGLUMINE	Merck Sharp & Dohme LLC	8d66803a-6811-4c29-9c57-e16acfa87f21	2026-02-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022023 application number: NDA022023

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
D35FM8T64X	FOSAPREPITANT DIMEGLUMINE	265121-04-8	FOSAPREPITANT DIMEGLUMINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1731080	Emend 115 MG Injection	PSN	44f634f4-b794-4d55-8ab7-037fdef8ff0f	30
1731082	Emend 150 MG Injection	PSN	44f634f4-b794-4d55-8ab7-037fdef8ff0f	30
1731075	fosaprepitant 115 MG Injection	PSN	44f634f4-b794-4d55-8ab7-037fdef8ff0f	30
1731077	fosaprepitant 150 MG Injection	PSN	44f634f4-b794-4d55-8ab7-037fdef8ff0f	30
1731080	fosaprepitant 115 MG Injection [Emend Injection]	SBD	44f634f4-b794-4d55-8ab7-037fdef8ff0f	30
1731082	fosaprepitant 150 MG Injection [Emend Injection]	SBD	44f634f4-b794-4d55-8ab7-037fdef8ff0f	30
1731075	fosaprepitant 115 MG Injection	SCD	44f634f4-b794-4d55-8ab7-037fdef8ff0f	30
1731077	fosaprepitant 150 MG Injection	SCD	44f634f4-b794-4d55-8ab7-037fdef8ff0f	30
1731080	Emend 115 MG (as fosaprepitant dimeglumine 188 MG) Injection	SY	44f634f4-b794-4d55-8ab7-037fdef8ff0f	30
1731082	Emend 150 MG (as fosaprepitant dimeglumine 245.3 MG) Injection	SY	44f634f4-b794-4d55-8ab7-037fdef8ff0f	30
1731075	fosaprepitant 115 MG (as fosaprepitant dimeglumine 188 MG) Injection	SY	44f634f4-b794-4d55-8ab7-037fdef8ff0f	30
1731077	fosaprepitant 150 MG (as fosaprepitant dimeglumine 245.3 MG) Injection	SY	44f634f4-b794-4d55-8ab7-037fdef8ff0f	30

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
0006-3941-01	00006394101	5 mL in 1 VIAL, SINGLE-DOSE	5 ml	Historical
0006-3941-32	00006394132	1 in 1 CARTON		Historical