fosaprepitant

Generic: fosaprepitant dimeglumine

Labeler: baxter healthcare corporation
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fosaprepitant
Generic Name fosaprepitant dimeglumine
Labeler baxter healthcare corporation
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

fosaprepitant dimeglumine 150 mg/5mL

Manufacturer
Baxter Healthcare Corporation

Identifiers & Regulatory

Product NDC 0338-0008
Product ID 0338-0008_67f5816c-3188-40f9-9a8f-97e92a26ff73
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211860
Listing Expiration 2027-12-31
Marketing Start 2019-09-05

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 03380008
Hyphenated Format 0338-0008

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 dimeglumine (source: ndc)
Application Number ANDA211860 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 150 mg/5mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (0338-0008-01) / 5 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

0338-0008-01 1 VIAL, SINGLE-DOSE in 1 CARTON (0338-0008-01) / 5 mL in 1 VIAL, SINGLE-DOSE

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": "67f5816c-3188-40f9-9a8f-97e92a26ff73", "openfda": {"unii": ["D35FM8T64X"], "rxcui": ["1731077"], "spl_set_id": ["3ed3e0a9-a0a8-4555-9f73-2043e79e3398"], "manufacturer_name": ["Baxter Healthcare Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (0338-0008-01)  / 5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0338-0008-01", "marketing_start_date": "20190905"}], "brand_name": "Fosaprepitant", "product_id": "0338-0008_67f5816c-3188-40f9-9a8f-97e92a26ff73", "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": "0338-0008", "generic_name": "Fosaprepitant Dimeglumine", "labeler_name": "Baxter Healthcare Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fosaprepitant", "active_ingredients": [{"name": "FOSAPREPITANT DIMEGLUMINE", "strength": "150 mg/5mL"}], "application_number": "ANDA211860", "marketing_category": "ANDA", "marketing_start_date": "20190905", "listing_expiration_date": "20271231"}