Home NDC 70121-2631 FOCINVEZ
Product NDC 70121-2631
11-digit product format 701212631
Labeler code 70121
Product ID 70121-2631_0ef109ec-d2f8-4c22-b20d-65db7f9c85a0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name FOSAPREPITANT DIMEGLUMINE
Dosage form INJECTION
Route INTRAVENOUS
Labeler Amneal Pharmaceuticals LLC
Application NDA216686
Marketing category NDA
Marketing start 2024-06-01
Substance FOSAPREPITANT DIMEGLUMINE
Active strength 150 mg/50mL
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N216686-001 FOCINVEZ FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/50ML (EQ 3MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-08-22
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N216686-001 11065265 2039-01-11 Drug product 2023-09-13 N216686-001 12042504 2039-01-11 Drug product 2024-08-12
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.
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 2026-02-19 14:30 UTC 2026-02 N216686-001 FOCINVEZ EQ 150MG BASE/50ML (EQ 3MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-08-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216686-001 FOCINVEZ EQ 150MG BASE/50ML (EQ 3MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-08-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N216686-001 FOCINVEZ EQ 150MG BASE/50ML (EQ 3MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-08-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216686-001 FOCINVEZ EQ 150MG BASE/50ML (EQ 3MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-08-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216686-001 FOCINVEZ EQ 150MG BASE/50ML (EQ 3MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-08-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216686-001 FOCINVEZ EQ 150MG BASE/50ML (EQ 3MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-08-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216686-001 FOCINVEZ EQ 150MG BASE/50ML (EQ 3MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-08-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216686-001 FOCINVEZ EQ 150MG BASE/50ML (EQ 3MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-08-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216686-001 FOCINVEZ EQ 150MG BASE/50ML (EQ 3MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-08-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N216686-001 FOCINVEZ EQ 150MG BASE/50ML (EQ 3MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-08-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N216686-001 FOCINVEZ EQ 150MG BASE/50ML (EQ 3MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-08-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N216686-001 FOCINVEZ EQ 150MG BASE/50ML (EQ 3MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-08-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N216686-001 FOCINVEZ EQ 150MG BASE/50ML (EQ 3MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-08-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N216686-001 FOCINVEZ EQ 150MG BASE/50ML (EQ 3MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-08-22 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N216686-001 FOCINVEZ EQ 150MG BASE/50ML (EQ 3MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-08-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N216686-001 FOCINVEZ EQ 150MG BASE/50ML (EQ 3MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-08-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N216686-001 FOCINVEZ EQ 150MG BASE/50ML (EQ 3MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-08-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N216686-001 FOCINVEZ EQ 150MG BASE/50ML (EQ 3MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-08-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N216686-001 FOCINVEZ EQ 150MG BASE/50ML (EQ 3MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-08-22 9b2671bbb829…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N216686-001 FOCINVEZ EQ 150MG BASE/50ML (EQ 3MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-08-22 a50c72e98297…
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 2026-02-19 14:30 UTC 2026-02 N216686-001 11065265 2039-01-11 Drug product 2023-09-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216686-001 12042504 2039-01-11 Drug product 2024-08-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216686-001 11065265 2039-01-11 Drug product 2023-09-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216686-001 12042504 2039-01-11 Drug product 2024-08-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N216686-001 11065265 2039-01-11 Drug product 2023-09-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216686-001 12042504 2039-01-11 Drug product 2024-08-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216686-001 11065265 2039-01-11 Drug product 2023-09-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216686-001 12042504 2039-01-11 Drug product 2024-08-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216686-001 11065265 2039-01-11 Drug product 2023-09-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216686-001 12042504 2039-01-11 Drug product 2024-08-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216686-001 11065265 2039-01-11 Drug product 2023-09-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216686-001 12042504 2039-01-11 Drug product 2024-08-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216686-001 11065265 2039-01-11 Drug product 2023-09-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216686-001 12042504 2039-01-11 Drug product 2024-08-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216686-001 11065265 2039-01-11 Drug product 2023-09-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216686-001 12042504 2039-01-11 Drug product 2024-08-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216686-001 11065265 2039-01-11 Drug product 2023-09-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216686-001 12042504 2039-01-11 Drug product 2024-08-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N216686-001 11065265 2039-01-11 Drug product 2023-09-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N216686-001 12042504 2039-01-11 Drug product 2024-08-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N216686-001 11065265 2039-01-11 Drug product 2023-09-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N216686-001 11065265 2039-01-11 Drug product 2023-09-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N216686-001 11065265 2039-01-11 Drug product 2023-09-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N216686-001 11065265 2039-01-11 Drug product 2023-09-13 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N216686-001 11065265 2039-01-11 Drug product 2023-09-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N216686-001 11065265 2039-01-11 Drug product 2023-09-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N216686-001 11065265 2039-01-11 Drug product 2023-09-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N216686-001 11065265 2039-01-11 Drug product 2023-09-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N216686-001 11065256 2039-01-11 Drug product 2023-09-13 9b2671bbb829…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N216686-001 11065265 2039-01-11 Drug product 2023-09-13 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N216686-001 12042504 2039-01-11 Drug product 2024-08-12 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base FOCINVEZ
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FOSAPREPITANT DIMEGLUMINE 150 mg/50mL
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 2664065 Internal RxNorm lookup 2664071 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 70121-2631-1 FOCINVEZ 50 mL in 1 VIAL, SINGLE-DOSE INJECTION 50 7 70121-2631-1 FOCINVEZ 1 in 1 CARTON INJECTION 1 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70121-2631 FOCINVEZ (FOSAPREPITANT DIMEGLUMINE) INJECTION [AMNEAL PHARMACEUTICALS LLC] 5 Current NDC, 2 package rows 20240606_7afe33d8-5416-465a-b98b-f4eedc327a94.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 70121-2631-1 70121263101 1 VIAL, SINGLE-DOSE in 1 CARTON (70121-2631-1) / 50 mL in 1 VIAL, SINGLE-DOSE 2024-06-15 No No Current