Home NDC 70121-2631 FOCINVEZ
Product NDC 70121-2631
11-digit product format 701212631
Labeler code 70121
Product ID 70121-2631_e637f5b2-5eba-4548-95b5-2d003f293f25
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 44 .
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 2026-10-15 13:18:30 2026-09 N216686-001 FOCINVEZ EQ 150MG BASE/50ML (EQ 3MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-08-22 c2088c7a36db…2026-09-14 22:38:34 2026-08 N216686-001 FOCINVEZ EQ 150MG BASE/50ML (EQ 3MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-08-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 N216686-001 FOCINVEZ EQ 150MG BASE/50ML (EQ 3MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-08-22 caaa826d4ba7…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 2026-10-15 13:18:30 2026-09 N216686-001 11065265 2039-01-11 Drug product 2023-09-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 N216686-001 12042504 2039-01-11 Drug product 2024-08-12 c2088c7a36db…2026-09-14 22:38:34 2026-08 N216686-001 11065265 2039-01-11 Drug product 2023-09-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216686-001 12042504 2039-01-11 Drug product 2024-08-12 84e616aacf4f…2026-08-18 06:07:40 2026-07 N216686-001 11065265 2039-01-11 Drug product 2023-09-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216686-001 12042504 2039-01-11 Drug product 2024-08-12 caaa826d4ba7…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…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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
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
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