Home NDC 0006-3061-04 EMEND
Product NDC 0006-3061
Requested package NDC 0006-3061-04
11-digit product format 000063061
Labeler code 0006
Product ID 0006-3061_20906e8e-8a3e-4c45-a657-6d4c1945af09
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name FOSAPREPITANT DIMEGLUMINE
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Merck Sharp & Dohme LLC
Application NDA022023
Marketing category NDA
Marketing start 2017-02-03
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 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 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FOSAPREPITANT DIMEGLUMINE EQ 115MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** POWDER / INTRAVENOUS RLD 2008-01-25 N022023-002 EMEND FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS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.
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date 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.
Additional Listing Data#
Finished product Yes
Brand name base EMEND
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1731077 Internal RxNorm lookup 1731082 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0006-3061-00 EMEND 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 20 0006-3061-01 EMEND 5 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 5 20
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0006-3061 EMEND (FOSAPREPITANT DIMEGLUMINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME LLC] 18 Current NDC, Legacy NDC, 2 package rows 20240111_8d66803a-6811-4c29-9c57-e16acfa87f21.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 ndc (product): 0006-3061
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0006-3061-04 00006306104 1 VIAL, SINGLE-DOSE in 1 CARTON (0006-3061-04) > 5 mL in 1 VIAL, SINGLE-DOSE (0006-3061-01) 2017-02-03 0000-00-00 No No Current