daptomycin

Generic: daptomycin

Labeler: xellia pharmaceuticals usa llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name daptomycin
Generic Name daptomycin
Labeler xellia pharmaceuticals usa llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

daptomycin 500 mg/10mL

Manufacturer
Xellia Pharmaceuticals USA LLC

Identifiers & Regulatory

Product NDC 70594-034
Product ID 70594-034_32561d31-66ad-4616-970c-2a7f043b0d0e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206005
Listing Expiration 2026-12-31
Marketing Start 2018-10-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70594034
Hyphenated Format 70594-034

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 ANDA206005 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/10mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-USE in 1 CARTON (70594-034-01) / 10 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (1)

70594-034-01 1 VIAL, SINGLE-USE in 1 CARTON (70594-034-01) / 10 mL in 1 VIAL, SINGLE-USE

Ingredients (1)

daptomycin (500 mg/10mL)

Linked Drug Pages (2)

Daptomycin ndc-match (0.9) Daptomycin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "32561d31-66ad-4616-970c-2a7f043b0d0e", "openfda": {"nui": ["N0000175509", "M0519359"], "unii": ["NWQ5N31VKK"], "rxcui": ["403920"], "spl_set_id": ["494b2aa1-020b-432c-977e-a5d74e31e342"], "pharm_class_cs": ["Lipopeptides [CS]"], "pharm_class_epc": ["Lipopeptide Antibacterial [EPC]"], "manufacturer_name": ["Xellia Pharmaceuticals USA LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-USE in 1 CARTON (70594-034-01)  / 10 mL in 1 VIAL, SINGLE-USE", "package_ndc": "70594-034-01", "marketing_start_date": "20181001"}], "brand_name": "Daptomycin", "product_id": "70594-034_32561d31-66ad-4616-970c-2a7f043b0d0e", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Lipopeptide Antibacterial [EPC]", "Lipopeptides [CS]"], "product_ndc": "70594-034", "generic_name": "Daptomycin", "labeler_name": "Xellia Pharmaceuticals USA LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Daptomycin", "active_ingredients": [{"name": "DAPTOMYCIN", "strength": "500 mg/10mL"}], "application_number": "ANDA206005", "marketing_category": "ANDA", "marketing_start_date": "20181001", "listing_expiration_date": "20261231"}