Fosaprepitant

Product NDC
43598-671
Requested package NDC
43598-671-11
11-digit product format
435980671
Labeler code
43598
Product ID
43598-671_aaffcc4e-88e7-4544-bedb-b508fddebd24
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fosaprepitant
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Dr. Reddy's Laboratories Inc.,
Application
ANDA211160
Marketing category
ANDA
Marketing start
2026-02-12
Substance
FOSAPREPITANT DIMEGLUMINE
Active strength
150 mg/1
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
A211160-001FOSAPREPITANT DIMEGLUMINEFOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2020-12-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A211160-001AP

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 UTC2026-02A211160-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2020-12-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211160-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2020-12-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A211160-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2020-12-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211160-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2020-12-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211160-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2020-12-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211160-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2020-12-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211160-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2020-12-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211160-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2020-12-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211160-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2020-12-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211160-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2020-12-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211160-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2020-12-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211160-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2020-12-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211160-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2020-12-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211160-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2020-12-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211160-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2020-12-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211160-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2020-12-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211160-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2020-12-094b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A211160-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2020-12-09bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211160-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2020-12-09782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211160-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2020-12-0987673890dc5c…
2021-03-12 10:30 UTC2021-03A211160-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2020-12-095aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A211160-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2020-12-098869cabd3fbd…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211160-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2020-12-096a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211160-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2020-12-091c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211160-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2020-12-09ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211160-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2020-12-09a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211160-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2020-12-099b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211160-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2020-12-09a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211160-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2020-12-093f0d92c62455…
2023-05-13 08:27 UTC2023-05A211160-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2020-12-09053a50430f4f…
2023-01-26 05:58 UTC2023-01A211160-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2020-12-093bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211160-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2020-12-093a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211160-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2020-12-09f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211160-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2020-12-09e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A211160-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2020-12-09cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211160-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2020-12-09a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A211160-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211160-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211160-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211160-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211160-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211160-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211160-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211160-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211160-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211160-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211160-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211160-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211160-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211160-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211160-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211160-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211160-001AP14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A211160-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211160-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211160-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A211160-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A211160-001AP18869cabd3fbd…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211160-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211160-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211160-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211160-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211160-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211160-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211160-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A211160-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A211160-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211160-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211160-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211160-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A211160-001AP1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211160-001AP1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Fosaprepitant
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FOSAPREPITANT DIMEGLUMINE150 mg/1

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
557a48d5-0e1f-f3d5-d3bc-db422d19c399Available 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
43598-671-11Fosaprepitant1 in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,19
43598-671-11Fosaprepitant1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-671-11EA - Each43598-671a77af354-a340-4c64-907f-6a0173c0145b12026-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-671FOSAPREPITANT INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [DR. REDDY'S LABORATORIES INC.,]8Current NDC, 2 package rows20241211_557a48d5-0e1f-f3d5-d3bc-db422d19c399.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
FosaprepitantFOSAPREPITANTDr. Reddy's Laboratories Inc.,557a48d5-0e1f-f3d5-d3bc-db422d19c3992025-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211160
application number: ANDA211160
ndc (package): 43598-671-11
ndc (product): 43598-671
ndc11 (package): 43598067111

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1731077fosaprepitant 150 MG InjectionPSN557a48d5-0e1f-f3d5-d3bc-db422d19c3999
1731077fosaprepitant 150 MG InjectionSCD557a48d5-0e1f-f3d5-d3bc-db422d19c3999
1731077fosaprepitant 150 MG (as fosaprepitant dimeglumine 245.3 MG) InjectionSY557a48d5-0e1f-f3d5-d3bc-db422d19c3999

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
43598-671-11435980671111 VIAL, SINGLE-DOSE in 1 CARTON (43598-671-11) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE2026-02-12NoNoCurrent