daptomycin

Generic: daptomycin

Labeler: par health usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

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

daptomycin 500 mg/1

Manufacturer
Par Health USA, LLC

Identifiers & Regulatory

Product NDC 42023-295
Product ID 42023-295_f210e0b8-5a7e-4ba9-b4ab-ad86a4ec8bf4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA217630
Listing Expiration 2026-12-31
Marketing Start 2025-10-27

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42023295
Hyphenated Format 42023-295

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 NDA217630 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (42023-295-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (42023-295-01)
source: ndc

Packages (1)

42023-295-10 10 VIAL, SINGLE-DOSE in 1 CARTON (42023-295-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (42023-295-01)

Ingredients (1)

daptomycin (500 mg/1)

Linked Drug Pages (1)

Daptomycin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "f210e0b8-5a7e-4ba9-b4ab-ad86a4ec8bf4", "openfda": {"nui": ["N0000175509", "M0519359"], "unii": ["NWQ5N31VKK"], "rxcui": ["403920"], "spl_set_id": ["c1d47001-5e0f-46a3-b220-53f46b4fd6ac"], "pharm_class_cs": ["Lipopeptides [CS]"], "pharm_class_epc": ["Lipopeptide Antibacterial [EPC]"], "manufacturer_name": ["Par Health USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (42023-295-10)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (42023-295-01)", "package_ndc": "42023-295-10", "marketing_start_date": "20251027"}], "brand_name": "Daptomycin", "product_id": "42023-295_f210e0b8-5a7e-4ba9-b4ab-ad86a4ec8bf4", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Lipopeptide Antibacterial [EPC]", "Lipopeptides [CS]"], "product_ndc": "42023-295", "generic_name": "Daptomycin", "labeler_name": "Par Health USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Daptomycin", "active_ingredients": [{"name": "DAPTOMYCIN", "strength": "500 mg/1"}], "application_number": "NDA217630", "marketing_category": "NDA", "marketing_start_date": "20251027", "listing_expiration_date": "20261231"}