Home NDC 0143-9428 FOSAPREPITANT DIMEGLUMINE
Product NDC 0143-9428
11-digit product format 001439428
Labeler code 0143
Product ID 0143-9428_337c9f18-b85b-4423-b16c-cded0f6ca361
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name FOSAPREPITANT DIMEGLUMINE
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA213106
Marketing category ANDA
Marketing start 2021-05-01
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 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 A213106-001 FOSAPREPITANT DIMEGLUMINE FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2020-09-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A213106-001 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 A213106-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2020-09-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213106-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2020-09-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213106-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2020-09-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213106-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2020-09-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213106-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2020-09-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213106-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2020-09-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213106-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2020-09-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213106-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2020-09-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213106-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2020-09-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213106-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2020-09-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213106-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2020-09-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213106-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2020-09-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213106-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2020-09-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213106-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2020-09-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213106-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2020-09-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213106-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2020-09-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A213106-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2020-09-08 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A213106-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2020-09-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A213106-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2020-09-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A213106-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2020-09-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A213106-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2020-09-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A213106-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2020-09-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A213106-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2020-09-08 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213106-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2020-09-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213106-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2020-09-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213106-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2020-09-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213106-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2020-09-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213106-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2020-09-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213106-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2020-09-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A213106-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2020-09-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A213106-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2020-09-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A213106-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2020-09-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A213106-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2020-09-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A213106-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2020-09-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A213106-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2020-09-08 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A213106-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2020-09-08 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213106-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2020-09-08 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base FOSAPREPITANT DIMEGLUMINE
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1731077 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 0143-9428-01 FOSAPREPITANT DIMEGLUMINE 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 5 0143-9428-01 FOSAPREPITANT DIMEGLUMINE 5 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 5 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0143-9428 FOSAPREPITANT DIMEGLUMINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.] 3 Current NDC, Legacy NDC, 2 package rows 20220413_1a7d2f44-b578-4d99-a4ff-f267626064d0.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 · 3 matching rows.
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 0143-9428-01 00143942801 1 VIAL, SINGLE-DOSE in 1 CARTON (0143-9428-01) / 5 mL in 1 VIAL, SINGLE-DOSE 2021-05-01 0000-00-00 No No Current