daptomycin

Generic: daptomycin

Labeler: sintetica us llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name daptomycin
Generic Name daptomycin
Labeler sintetica us llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
Routes
INTRAVENOUS
Active Ingredients

daptomycin 500 mg/20mL

Manufacturer
Sintetica US LLC

Identifiers & Regulatory

Product NDC 83090-011
Product ID 83090-011_5ef48d1a-eecc-4782-b347-7930a733e603
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215890
Listing Expiration 2026-12-31
Marketing Start 2023-11-05

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83090011
Hyphenated Format 83090-011

Supplemental Identifiers

RxCUI
403920
UPC
0383090011010
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 ANDA215890 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/20mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (83090-011-01) / 10 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

83090-011-01 1 VIAL, SINGLE-DOSE in 1 CARTON (83090-011-01) / 10 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

daptomycin (500 mg/20mL)

Linked Drug Pages (1)

daptomycin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "5ef48d1a-eecc-4782-b347-7930a733e603", "openfda": {"nui": ["N0000175509", "M0519359"], "upc": ["0383090011010"], "unii": ["NWQ5N31VKK"], "rxcui": ["403920"], "spl_set_id": ["0e55bfa7-7dbf-4fa1-8aee-eac3fe4e05e3"], "pharm_class_cs": ["Lipopeptides [CS]"], "pharm_class_epc": ["Lipopeptide Antibacterial [EPC]"], "manufacturer_name": ["Sintetica US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (83090-011-01)  / 10 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "83090-011-01", "marketing_start_date": "20231105"}], "brand_name": "daptomycin", "product_id": "83090-011_5ef48d1a-eecc-4782-b347-7930a733e603", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION", "pharm_class": ["Lipopeptide Antibacterial [EPC]", "Lipopeptides [CS]"], "product_ndc": "83090-011", "generic_name": "daptomycin", "labeler_name": "Sintetica US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "daptomycin", "active_ingredients": [{"name": "DAPTOMYCIN", "strength": "500 mg/20mL"}], "application_number": "ANDA215890", "marketing_category": "ANDA", "marketing_start_date": "20231105", "listing_expiration_date": "20261231"}