daptomycin

Generic: daptomycin

Labeler: mylan institutional llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name daptomycin
Generic Name daptomycin
Labeler mylan institutional llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

daptomycin 500 mg/10mL

Manufacturer
Mylan Institutional LLC

Identifiers & Regulatory

Product NDC 67457-813
Product ID 67457-813_c32c2064-dd66-4c7f-a35b-c98048a4d3d2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205037
Listing Expiration 2026-12-31
Marketing Start 2018-09-04

Pharmacologic Class

Established (EPC)
lipopeptide antibacterial [epc]
Chemical Structure
lipopeptides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67457813
Hyphenated Format 67457-813

Supplemental Identifiers

RxCUI
403920
UNII
NWQ5N31VKK
NUI
N0000175509 M0519359

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 daptomycin (source: ndc)
Generic Name daptomycin (source: ndc)
Application Number ANDA205037 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/10mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (67457-813-50) / 10 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

67457-813-50 1 VIAL, SINGLE-DOSE in 1 CARTON (67457-813-50) / 10 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

daptomycin (500 mg/10mL)

Linked Drug Pages (1)

daptomycin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "c32c2064-dd66-4c7f-a35b-c98048a4d3d2", "openfda": {"nui": ["N0000175509", "M0519359"], "unii": ["NWQ5N31VKK"], "rxcui": ["403920"], "spl_set_id": ["b7737862-e783-4af3-9521-ae00ed7a42aa"], "pharm_class_cs": ["Lipopeptides [CS]"], "pharm_class_epc": ["Lipopeptide Antibacterial [EPC]"], "manufacturer_name": ["Mylan Institutional LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (67457-813-50)  / 10 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "67457-813-50", "marketing_start_date": "20180904"}], "brand_name": "daptomycin", "product_id": "67457-813_c32c2064-dd66-4c7f-a35b-c98048a4d3d2", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Lipopeptide Antibacterial [EPC]", "Lipopeptides [CS]"], "product_ndc": "67457-813", "generic_name": "daptomycin", "labeler_name": "Mylan Institutional LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "daptomycin", "active_ingredients": [{"name": "DAPTOMYCIN", "strength": "500 mg/10mL"}], "application_number": "ANDA205037", "marketing_category": "ANDA", "marketing_start_date": "20180904", "listing_expiration_date": "20261231"}