caspofungin acetate

Generic: caspofungin acetate

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name caspofungin acetate
Generic Name caspofungin acetate
Labeler gland pharma limited
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

caspofungin acetate 7 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-159
Product ID 68083-159_0ebc13ad-ba33-408f-8af3-cf995efc4df2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207092
Listing Expiration 2026-12-31
Marketing Start 2017-10-29

Pharmacologic Class

Classes
echinocandin antifungal [epc] lipopeptides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083159
Hyphenated Format 68083-159

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 ANDA207092 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 7 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (68083-159-01) / 10 mL in 1 VIAL
source: ndc

Packages (1)

68083-159-01 1 VIAL in 1 CARTON (68083-159-01) / 10 mL in 1 VIAL

Ingredients (1)

caspofungin acetate (7 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": "0ebc13ad-ba33-408f-8af3-cf995efc4df2", "openfda": {"unii": ["VUW370O5QE"], "rxcui": ["828539", "828755"], "spl_set_id": ["29da357e-e7fc-46af-bf20-806a1e4b5391"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (68083-159-01)  / 10 mL in 1 VIAL", "package_ndc": "68083-159-01", "marketing_start_date": "20171029"}], "brand_name": "Caspofungin Acetate", "product_id": "68083-159_0ebc13ad-ba33-408f-8af3-cf995efc4df2", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Echinocandin Antifungal [EPC]", "Lipopeptides [CS]"], "product_ndc": "68083-159", "generic_name": "Caspofungin Acetate", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Caspofungin Acetate", "active_ingredients": [{"name": "CASPOFUNGIN ACETATE", "strength": "7 mg/mL"}], "application_number": "ANDA207092", "marketing_category": "ANDA", "marketing_start_date": "20171029", "listing_expiration_date": "20261231"}