daptomycin

Generic: daptomycin

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name daptomycin
Generic Name daptomycin
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

daptomycin 350 mg/7mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9456
Product ID 0143-9456_8aa40ade-a628-428b-898c-076d94c40940
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA217415
Listing Expiration 2027-12-31
Marketing Start 2025-12-11

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01439456
Hyphenated Format 0143-9456

Supplemental Identifiers

RxCUI
403920 1996246
UPC
0301439445012 0301439456018
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 NDA217415 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 350 mg/7mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-USE in 1 CARTON (0143-9456-01) / 7 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (1)

0143-9456-01 1 VIAL, SINGLE-USE in 1 CARTON (0143-9456-01) / 7 mL in 1 VIAL, SINGLE-USE

Ingredients (1)

daptomycin (350 mg/7mL)

Linked Drug Pages (1)

Daptomycin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "8aa40ade-a628-428b-898c-076d94c40940", "openfda": {"nui": ["N0000175509", "M0519359"], "upc": ["0301439445012", "0301439456018"], "unii": ["NWQ5N31VKK"], "rxcui": ["403920", "1996246"], "spl_set_id": ["74176769-b22e-4e41-8c56-051e15ec5fea"], "pharm_class_cs": ["Lipopeptides [CS]"], "pharm_class_epc": ["Lipopeptide Antibacterial [EPC]"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-USE in 1 CARTON (0143-9456-01)  / 7 mL in 1 VIAL, SINGLE-USE", "package_ndc": "0143-9456-01", "marketing_start_date": "20251211"}], "brand_name": "Daptomycin", "product_id": "0143-9456_8aa40ade-a628-428b-898c-076d94c40940", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Lipopeptide Antibacterial [EPC]", "Lipopeptides [CS]"], "product_ndc": "0143-9456", "generic_name": "daptomycin", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Daptomycin", "active_ingredients": [{"name": "DAPTOMYCIN", "strength": "350 mg/7mL"}], "application_number": "NDA217415", "marketing_category": "NDA", "marketing_start_date": "20251211", "listing_expiration_date": "20271231"}