daptomycin

Generic: daptomycin

Labeler: sagent pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

daptomycin 50 mg/mL

Manufacturer
Sagent Pharmaceuticals

Identifiers & Regulatory

Product NDC 25021-174
Product ID 25021-174_a3f62ffc-f089-4f4c-bad1-99f60f1d88b0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207104
Listing Expiration 2026-12-31
Marketing Start 2019-11-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 25021174
Hyphenated Format 25021-174

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 ANDA207104 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (25021-174-15) / 10 mL in 1 VIAL
  • 10 VIAL in 1 CARTON (25021-174-16) / 10 mL in 1 VIAL
source: ndc

Packages (2)

25021-174-15 1 VIAL in 1 CARTON (25021-174-15) / 10 mL in 1 VIAL 25021-174-16 10 VIAL in 1 CARTON (25021-174-16) / 10 mL in 1 VIAL

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": "a3f62ffc-f089-4f4c-bad1-99f60f1d88b0", "openfda": {"nui": ["N0000175509", "M0519359"], "unii": ["NWQ5N31VKK"], "rxcui": ["403920"], "spl_set_id": ["f4ad8613-f25e-4b82-9621-cc5ff9525d3e"], "pharm_class_cs": ["Lipopeptides [CS]"], "pharm_class_epc": ["Lipopeptide Antibacterial [EPC]"], "manufacturer_name": ["Sagent Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (25021-174-15)  / 10 mL in 1 VIAL", "package_ndc": "25021-174-15", "marketing_start_date": "20191115"}, {"sample": false, "description": "10 VIAL in 1 CARTON (25021-174-16)  / 10 mL in 1 VIAL", "package_ndc": "25021-174-16", "marketing_start_date": "20191115"}], "brand_name": "daptomycin", "product_id": "25021-174_a3f62ffc-f089-4f4c-bad1-99f60f1d88b0", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Lipopeptide Antibacterial [EPC]", "Lipopeptides [CS]"], "product_ndc": "25021-174", "generic_name": "daptomycin", "labeler_name": "Sagent Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "daptomycin", "active_ingredients": [{"name": "DAPTOMYCIN", "strength": "50 mg/mL"}], "application_number": "ANDA207104", "marketing_category": "ANDA", "marketing_start_date": "20191115", "listing_expiration_date": "20261231"}