Fosaprepitant

Product NDC
69539-034
11-digit product format
695390034
Labeler code
69539
Product ID
69539-034_1ace4714-01cd-47be-8c71-f08093c20862
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fosaprepitant
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
MSN LABORATORIES PRIVATE LIMITED
Application
ANDA209965
Marketing category
ANDA
Marketing start
2019-09-05
Marketing end
0000-00-00
Substance
FOSAPREPITANT DIMEGLUMINE
Active strength
150 mg/5mL
Pharmacologic classes
Neurokinin 1 Antagonists [MoA],Substance P/Neurokinin-1 Receptor Antagonist [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 3A4 Inducers [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct69539-034DDiscontinued by firm2026-08-07
excluded packagepackage69539-03469539-034-01DDiscontinued by firm2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69539-034-01DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69539-034-01IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage69539-034-01IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage69539-034-01IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage69539-034-01IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage69539-034-01IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69539-034-01UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69539-034-01UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69539-034-01UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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
A209965-001FOSAPREPITANT DIMEGLUMINEFOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2019-09-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209965-001AP

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 UTC2026-02A209965-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2019-09-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209965-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2019-09-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A209965-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2019-09-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209965-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2019-09-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209965-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2019-09-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209965-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2019-09-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209965-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2019-09-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209965-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2019-09-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209965-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2019-09-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209965-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2019-09-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209965-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2019-09-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209965-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2019-09-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209965-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2019-09-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209965-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2019-09-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209965-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2019-09-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209965-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2019-09-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209965-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2019-09-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209965-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2019-09-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209965-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2019-09-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209965-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2019-09-05782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209965-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2019-09-0587673890dc5c…
2021-03-12 10:30 UTC2021-03A209965-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2019-09-055aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209965-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2019-09-058869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209965-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2019-09-05c0c555d07b60…
2019-12-14 00:12 UTC2019-12A209965-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2019-09-053f01610625f2…
2019-09-15 20:21 UTC2019-09A209965-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2019-09-05b00525d2431f…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209965-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2019-09-056a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209965-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2019-09-051c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209965-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2019-09-05ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209965-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2019-09-05a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209965-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2019-09-059b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209965-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2019-09-05a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209965-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2019-09-053f0d92c62455…
2023-05-13 08:27 UTC2023-05A209965-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2019-09-05053a50430f4f…
2023-01-26 05:58 UTC2023-01A209965-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2019-09-053bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209965-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2019-09-053a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209965-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2019-09-05f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A209965-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2019-09-05e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A209965-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2019-09-05cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A209965-001FOSAPREPITANT DIMEGLUMINEEQ 150MG BASE/VIALPOWDER / INTRAVENOUSAP2019-09-05a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A209965-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209965-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209965-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209965-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209965-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209965-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209965-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209965-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209965-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209965-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209965-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209965-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209965-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209965-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209965-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209965-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209965-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209965-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209965-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209965-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209965-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A209965-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209965-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209965-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A209965-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A209965-001AP1b00525d2431f…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209965-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209965-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209965-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209965-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209965-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209965-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209965-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A209965-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A209965-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209965-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209965-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A209965-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A209965-001AP1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A209965-001AP1a50c72e98297…

FDA-Initiated Inactive NDC Indexing#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69539-034FOSAPREPITANT INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MSN LABORATORIES PRIVATE LIMITED]8Legacy NDC20191228_1f80f069-0796-4540-a2f3-2e33d592da6c.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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FosaprepitantFOSAPREPITANTNorthstar Rx LLCbf207918-100d-4917-88b0-3433c0e722492026-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209965
application number: ANDA209965
FosaprepitantFOSAPREPITANTBryant Ranch Prepack679c195a-cf59-4ca5-aa05-fa35d08ddb5c2026-05-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209965
application number: ANDA209965
FosaprepitantFOSAPREPITANTBluePoint Laboratoriesad89825f-aa31-469f-9685-159a4524dfdc2025-10-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209965
application number: ANDA209965
FosaprepitantFOSAPREPITANTDr. Reddy's Laboratories Inc.,f34c931c-78b9-90c1-3fa5-bb34a227f2ad2024-12-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209965
application number: ANDA209965
FosaprepitantFOSAPREPITANTNovadoz Pharmaceuticals LLC1e6b36b2-3c8b-4ac4-827e-d6f00d9990322022-09-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209965
application number: ANDA209965
FosaprepitantFOSAPREPITANTNovadoz Pharmaceuticals LLCa7343abe-b2b0-4e5a-907b-532a8e16dfcb2021-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209965
application number: ANDA209965
FosaprepitantFOSAPREPITANTDr. Reddy's Laboratories Inc.,d624667d-ee3b-3501-53fe-da453352042d2020-03-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209965
application number: ANDA209965

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69539-034-01695390034011 VIAL, SINGLE-DOSE in 1 CARTON (69539-034-01) > 5 mL in 1 VIAL, SINGLE-DOSE2019-09-050000-00-00NoNoCurrent