Home NDC 59651-523 FOSAPREPITANT DIMEGLUMINE
Product NDC 59651-523
11-digit product format 596510523
Labeler code 59651
Product ID 59651-523_3bb1ce3e-0a57-4363-9c95-e19e8b1d3f33
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name FOSAPREPITANT DIMEGLUMINE
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Aurobindo Pharma Limited
Application ANDA210625
Marketing category ANDA
Marketing start 2021-01-12
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 2022-12-31
Current FDA listing Historical FDA.report record 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 A210625-001 FOSAPREPITANT DIMEGLUMINE FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2021-01-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210625-001 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.
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 A210625-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2021-01-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210625-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2021-01-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210625-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2021-01-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210625-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2021-01-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210625-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2021-01-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210625-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2021-01-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210625-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2021-01-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210625-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2021-01-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210625-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2021-01-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210625-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2021-01-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210625-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2021-01-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210625-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2021-01-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210625-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2021-01-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210625-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2021-01-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210625-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2021-01-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210625-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2021-01-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210625-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2021-01-12 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A210625-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2021-01-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210625-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2021-01-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210625-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2021-01-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210625-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2021-01-12 5aa47cf7b7d7…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210625-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2021-01-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210625-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2021-01-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210625-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2021-01-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210625-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2021-01-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210625-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2021-01-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210625-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2021-01-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210625-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2021-01-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210625-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2021-01-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210625-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2021-01-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210625-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2021-01-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210625-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2021-01-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A210625-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2021-01-12 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A210625-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2021-01-12 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A210625-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2021-01-12 a50c72e98297…
Observed Orange Book normalized TE history# 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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 59651-523-01 59651052301 1 VIAL, SINGLE-DOSE in 1 CARTON (59651-523-01) > 5 mL in 1 VIAL, SINGLE-DOSE 2021-01-12 0000-00-00 No No Current