caspofungin acetate

Generic: caspofungin acetate

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name caspofungin acetate
Generic Name caspofungin acetate
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

caspofungin acetate 5 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-356
Product ID 63323-356_7cdf103b-418f-42a8-bd1b-ebfd8027124a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA206110
Listing Expiration 2027-12-31
Marketing Start 2016-12-30

Pharmacologic Class

Classes
echinocandin antifungal [epc] lipopeptides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323356
Hyphenated Format 63323-356

Supplemental Identifiers

RxCUI
828539 828755
UNII
VUW370O5QE

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 caspofungin acetate (source: ndc)
Generic Name caspofungin acetate (source: ndc)
Application Number NDA206110 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (63323-356-10) / 10.8 mL in 1 VIAL, SINGLE-DOSE (63323-356-01)
source: ndc

Packages (1)

63323-356-10 10 VIAL, SINGLE-DOSE in 1 CARTON (63323-356-10) / 10.8 mL in 1 VIAL, SINGLE-DOSE (63323-356-01)

Ingredients (1)

caspofungin acetate (5 mg/mL)

Linked Drug Pages (1)

Caspofungin Acetate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "7cdf103b-418f-42a8-bd1b-ebfd8027124a", "openfda": {"unii": ["VUW370O5QE"], "rxcui": ["828539", "828755"], "spl_set_id": ["e76d8d83-3691-451c-a32c-d91448c54d16"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (63323-356-10)  / 10.8 mL in 1 VIAL, SINGLE-DOSE (63323-356-01)", "package_ndc": "63323-356-10", "marketing_start_date": "20161230"}], "brand_name": "Caspofungin Acetate", "product_id": "63323-356_7cdf103b-418f-42a8-bd1b-ebfd8027124a", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Echinocandin Antifungal [EPC]", "Lipopeptides [CS]"], "product_ndc": "63323-356", "generic_name": "Caspofungin Acetate", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Caspofungin Acetate", "active_ingredients": [{"name": "CASPOFUNGIN ACETATE", "strength": "5 mg/mL"}], "application_number": "NDA206110", "marketing_category": "NDA", "marketing_start_date": "20161230", "listing_expiration_date": "20271231"}