fosaprepitant

Generic: fosaprepitant

Labeler: bluepoint laboratories
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fosaprepitant
Generic Name fosaprepitant
Labeler bluepoint laboratories
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

fosaprepitant dimeglumine 150 mg/5mL

Manufacturer
BluePoint Laboratories

Identifiers & Regulatory

Product NDC 68001-421
Product ID 68001-421_0f37486e-8181-f7cf-e063-6394a90a9af1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205020
Listing Expiration 2026-12-31
Marketing Start 2019-11-20

Pharmacologic Class

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]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68001421
Hyphenated Format 68001-421

Supplemental Identifiers

RxCUI
1731077
UNII
D35FM8T64X

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name fosaprepitant (source: ndc)
Generic Name fosaprepitant (source: ndc)
Application Number ANDA205020 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 150 mg/5mL
source: ndc
Packaging
  • 16 HOW SUPPLIED/STORAGE AND HANDLING Single-dose glass vial containing 150 mg of fosaprepitant as a white lyophilized powder or cake for reconstitution. Supplied as follows: NDC 68001-421-22 1 vial per carton. Storage Fosaprepitant for injection vials must be refrigerated, store at 2°C to 8°C (36°F to 46°F). The reconstituted final drug solution is stable for 24 hours at ambient room temperature [at or below 25°C (77°F)].
  • PACKAGE LABEL PRINCIPAL DISPLAY PANEL SECTION - CARTON NDC 68001-421-22 Fosaprepitant for Injection 150 mg per vial* Rx only One Single-dose Vial Discard Unused Portion STERILE LYOPHILIZED POWDER FOR INTRAVENOUS USE ONLY AFTER RECONSTITUTION AND DILUTION DO NOT USE WITH SOLUTIONS CONTAINING DIVALENT CATIONS (e.g., Ca2+, Mg2+) INCLUDING LACTATED RINGER'S SOLUTION AND HARTMANN'S SOLUTION. Fosaprepitant for injection 150 mg carton label
source: label

Packages (0)

No package records.

Ingredients (1)

fosaprepitant dimeglumine (150 mg/5mL)

Linked Drug Pages (1)

Fosaprepitant ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "0f37486e-8181-f7cf-e063-6394a90a9af1", "openfda": {"unii": ["D35FM8T64X"], "rxcui": ["1731077"], "spl_set_id": ["46edae30-d50c-4112-9941-954b13ed5eda"], "manufacturer_name": ["BluePoint Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "Fosaprepitant", "product_id": "68001-421_0f37486e-8181-f7cf-e063-6394a90a9af1", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["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]"], "product_ndc": "68001-421", "generic_name": "Fosaprepitant", "labeler_name": "BluePoint Laboratories", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fosaprepitant", "active_ingredients": [{"name": "FOSAPREPITANT DIMEGLUMINE", "strength": "150 mg/5mL"}], "application_number": "ANDA205020", "marketing_category": "ANDA", "marketing_start_date": "20191120", "listing_expiration_date": "20261231"}