Home NDC 69097-830-37 fosaprepitant
Product NDC 69097-830
Requested package NDC 69097-830-37
11-digit product format 690970830
Labeler code 69097
Product ID 69097-830_5d828458-1e4f-4e36-9e9f-74c846722b04
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name fosaprepitant
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Cipla USA Inc.
Application ANDA212309
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 2022-12-31
Current FDA listing Historical FDA.report record 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 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 69097-830 69097-830-37 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
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# DailyMed Product Concepts# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69097-830 FOSAPREPITANT INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CIPLA USA INC.] 2 Legacy NDC 20210217_cb36d3fb-4e13-4953-961d-b0e353c94942.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 69097-830-37 69097083037 1 VIAL, SINGLE-DOSE in 1 CARTON (69097-830-37) > 5 mL in 1 VIAL, SINGLE-DOSE 2019-09-05 0000-00-00 No No Current