daptomycin

Generic: daptomycin

Labeler: civica, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

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

daptomycin 350 mg/7mL

Manufacturer
Civica, Inc.

Identifiers & Regulatory

Product NDC 72572-100
Product ID 72572-100_379772be-8d89-44c0-ad76-bdc2377f9705
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA209949
Listing Expiration 2026-12-31
Marketing Start 2019-09-03

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72572100
Hyphenated Format 72572-100

Supplemental Identifiers

RxCUI
1996246
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 NDA209949 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 350 mg/7mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-USE in 1 CARTON (72572-100-01) / 7 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (1)

72572-100-01 1 VIAL, SINGLE-USE in 1 CARTON (72572-100-01) / 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": "379772be-8d89-44c0-ad76-bdc2377f9705", "openfda": {"nui": ["N0000175509", "M0519359"], "unii": ["NWQ5N31VKK"], "rxcui": ["1996246"], "spl_set_id": ["bcacf746-a3ee-48b5-bfbe-6a2b548ad24c"], "pharm_class_cs": ["Lipopeptides [CS]"], "pharm_class_epc": ["Lipopeptide Antibacterial [EPC]"], "manufacturer_name": ["Civica, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-USE in 1 CARTON (72572-100-01)  / 7 mL in 1 VIAL, SINGLE-USE", "package_ndc": "72572-100-01", "marketing_start_date": "20190903"}], "brand_name": "Daptomycin", "product_id": "72572-100_379772be-8d89-44c0-ad76-bdc2377f9705", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Lipopeptide Antibacterial [EPC]", "Lipopeptides [CS]"], "product_ndc": "72572-100", "generic_name": "Daptomycin", "labeler_name": "Civica, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Daptomycin", "active_ingredients": [{"name": "DAPTOMYCIN", "strength": "350 mg/7mL"}], "application_number": "NDA209949", "marketing_category": "NDA", "marketing_start_date": "20190903", "listing_expiration_date": "20261231"}