FOSAPREPITANT DIMEGLUMINE

Product NDC
55150-299
11-digit product format
551500299
Labeler code
55150
Product ID
55150-299_048f8975-d1ab-4d91-b819-552bc651c6ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FOSAPREPITANT DIMEGLUMINE
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Eugia US LLC
Application
ANDA210625
Marketing category
ANDA
Marketing start
2021-01-12
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 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210625-001FOSAPREPITANT DIMEGLUMINEFOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2021-01-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A210625-001AP

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A210625-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2021-01-12c2088c7a36db…
2026-09-14 22:38:342026-08A210625-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2021-01-1284e616aacf4f…
2026-08-18 06:07:402026-07A210625-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2021-01-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210625-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2021-01-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210625-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2021-01-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A210625-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2021-01-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210625-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2021-01-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210625-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2021-01-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210625-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2021-01-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210625-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2021-01-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210625-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2021-01-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210625-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2021-01-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210625-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2021-01-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210625-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2021-01-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210625-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2021-01-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210625-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2021-01-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210625-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2021-01-128072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210625-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2021-01-125c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210625-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2021-01-125d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210625-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2021-01-124b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A210625-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2021-01-12bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210625-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2021-01-12782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210625-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2021-01-1287673890dc5c…
2021-03-12 10:30 UTC2021-03A210625-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2021-01-125aa47cf7b7d7…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210625-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2021-01-126a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210625-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2021-01-121c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210625-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2021-01-12ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210625-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2021-01-12a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210625-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2021-01-129b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210625-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2021-01-12a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210625-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2021-01-123f0d92c62455…
2023-05-13 08:27 UTC2023-05A210625-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2021-01-12053a50430f4f…
2023-01-26 05:58 UTC2023-01A210625-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2021-01-123bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210625-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2021-01-123a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210625-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2021-01-12f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210625-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2021-01-12e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A210625-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2021-01-12cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210625-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2021-01-12a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A210625-001AP1c2088c7a36db…
2026-09-14 22:38:342026-08A210625-001AP184e616aacf4f…
2026-08-18 06:07:402026-07A210625-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210625-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210625-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210625-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210625-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210625-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210625-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210625-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210625-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210625-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210625-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210625-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210625-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210625-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210625-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210625-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210625-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210625-001AP14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A210625-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210625-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210625-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A210625-001AP15aa47cf7b7d7…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210625-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210625-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210625-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210625-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210625-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210625-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210625-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A210625-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A210625-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210625-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210625-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210625-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A210625-001AP1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210625-001AP1a50c72e98297…

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
FOSAPREPITANT DIMEGLUMINE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FOSAPREPITANT DIMEGLUMINE150 mg/5mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2abc3e32-ae1f-4dec-be1c-0c39ac95b38eProduct name720240514
5d352eda-d4de-4572-9a3f-32d6fd204f9aProduct name120230911
3a5d67cc-4a03-45a3-8d74-5aeb67631be4Product name120230831
85fc66a9-58b2-e194-7cdb-89ff44dcf3e6Product name420210518
9f9a82fd-fcee-442f-9233-7f2d2f9f4568Product name120180108

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55150-299-01FOSAPREPITANT DIMEGLUMINE5 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,57
55150-299-01FOSAPREPITANT DIMEGLUMINE1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55150-299-01EA - Each55150-2993b63c36d-f67c-4801-b523-eff9f397f1ba12021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-299FOSAPREPITANT DIMEGLUMINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [EUGIA US LLC]6Current NDC, Legacy NDC, 2 package rows20240222_19919480-960b-4741-9611-c133d68512f5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1731077fosaprepitant 150 MG InjectionPSN19919480-960b-4741-9611-c133d68512f57
1731077fosaprepitant 150 MG InjectionSCD19919480-960b-4741-9611-c133d68512f57
1731077fosaprepitant 150 MG (as fosaprepitant dimeglumine 245.3 MG) InjectionSY19919480-960b-4741-9611-c133d68512f57

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55150-299-01551500299011 VIAL, SINGLE-DOSE in 1 CARTON (55150-299-01) / 5 mL in 1 VIAL, SINGLE-DOSE2021-01-120000-00-00NoNoCurrent