daptomycin

Generic: daptomycin

Labeler: northstar rxllc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name daptomycin
Generic Name daptomycin
Labeler northstar rxllc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

daptomycin 50 mg/mL

Manufacturer
NorthStar RxLLC

Identifiers & Regulatory

Product NDC 16714-892
Product ID 16714-892_92b0bfe9-7694-3806-12c2-9d9b4f6ddfa7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208375
Marketing Start 2022-06-13
Marketing End 2026-06-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16714892
Hyphenated Format 16714-892

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 ANDA208375 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (16714-892-01) / 15 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

16714-892-01 1 VIAL, SINGLE-DOSE in 1 CARTON (16714-892-01) / 15 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

daptomycin (50 mg/mL)

Linked Drug Pages (1)

Daptomycin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "92b0bfe9-7694-3806-12c2-9d9b4f6ddfa7", "openfda": {"nui": ["N0000175509", "M0519359"], "unii": ["NWQ5N31VKK"], "rxcui": ["403920"], "spl_set_id": ["1c5dee92-299e-26f6-6332-e6a8fd376526"], "pharm_class_cs": ["Lipopeptides [CS]"], "pharm_class_epc": ["Lipopeptide Antibacterial [EPC]"], "manufacturer_name": ["NorthStar RxLLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (16714-892-01)  / 15 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "16714-892-01", "marketing_end_date": "20260630", "marketing_start_date": "20220613"}], "brand_name": "Daptomycin", "product_id": "16714-892_92b0bfe9-7694-3806-12c2-9d9b4f6ddfa7", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Lipopeptide Antibacterial [EPC]", "Lipopeptides [CS]"], "product_ndc": "16714-892", "generic_name": "Daptomycin", "labeler_name": "NorthStar RxLLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Daptomycin", "active_ingredients": [{"name": "DAPTOMYCIN", "strength": "50 mg/mL"}], "application_number": "ANDA208375", "marketing_category": "ANDA", "marketing_end_date": "20260630", "marketing_start_date": "20220613"}