FOSAPREPITANT DIMEGLUMINE

Product NDC
55150-299
11-digit product format
551500299
Labeler code
55150
Product ID
55150-299_cfb1b23b-6aa1-404b-a652-8347d5c36d7e
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 1.

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
2026-02-19 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
2026-02-19 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…

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
D35FM8T64XInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1731077Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
19919480-960b-4741-9611-c133d68512f5Available on FDA.report

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

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FOSAPREPITANT DIMEGLUMINEFOSAPREPITANT DIMEGLUMINEEugia US LLC19919480-960b-4741-9611-c133d68512f52026-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210625
application number: ANDA210625
ndc (product): 55150-299

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