Home NDC 71839-104 fosaprepitant
Product NDC 71839-104
11-digit product format 718390104
Labeler code 71839
Product ID 71839-104_1b1fe4ce-02d6-4ca1-8168-37b099caa434
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name fosaprepitant
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler BE Pharmaceuticals Inc.
Application ANDA212309
Marketing category ANDA
Marketing start 2019-10-15
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 2026-12-31
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 A212309-001 FOSAPREPITANT DIMEGLUMINE FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2019-09-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212309-001 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 A212309-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2019-09-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212309-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2019-09-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212309-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2019-09-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212309-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2019-09-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212309-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2019-09-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212309-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2019-09-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212309-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2019-09-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212309-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2019-09-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212309-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2019-09-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212309-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2019-09-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212309-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2019-09-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212309-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2019-09-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212309-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2019-09-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212309-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2019-09-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212309-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2019-09-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212309-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2019-09-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212309-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2019-09-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A212309-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2019-09-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A212309-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2019-09-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A212309-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2019-09-05 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A212309-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2019-09-05 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A212309-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2019-09-05 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A212309-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2019-09-05 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A212309-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2019-09-05 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A212309-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2019-09-05 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A212309-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2019-09-05 b00525d2431f…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212309-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2019-09-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212309-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2019-09-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212309-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2019-09-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212309-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2019-09-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212309-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2019-09-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212309-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2019-09-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A212309-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2019-09-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A212309-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2019-09-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A212309-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2019-09-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A212309-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2019-09-05 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A212309-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2019-09-05 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A212309-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2019-09-05 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A212309-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2019-09-05 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212309-001 FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER / INTRAVENOUS AP 2019-09-05 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base fosaprepitant
Listing expiration 2026-12-31 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 71839-104-01 fosaprepitant 5 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 5 9 71839-104-01 fosaprepitant 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71839-104 FOSAPREPITANT INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BE PHARMACEUTICALS INC.] 8 Current NDC, Legacy NDC, 2 package rows 20240926_21b08b87-70e3-4233-9531-dd6d84eab5d0.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.
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 71839-104-01 71839010401 1 VIAL, SINGLE-DOSE in 1 CARTON (71839-104-01) / 5 mL in 1 VIAL, SINGLE-DOSE 2019-10-15 0000-00-00 No No Current