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 350 mg/7mL

Manufacturer
NorthStar RxLLC

Identifiers & Regulatory

Product NDC 72603-147
Product ID 72603-147_f9aa5759-84d0-be13-e053-6294a90af8c3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216445
Listing Expiration 2026-12-31
Marketing Start 2023-04-18

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72603147
Hyphenated Format 72603-147

Supplemental Identifiers

RxCUI
1996246
UPC
0372603147018
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 ANDA216445 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 350 mg/7mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (72603-147-01) / 7 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

72603-147-01 1 VIAL, SINGLE-DOSE in 1 CARTON (72603-147-01) / 7 mL in 1 VIAL, SINGLE-DOSE

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": "f9aa5759-84d0-be13-e053-6294a90af8c3", "openfda": {"nui": ["N0000175509", "M0519359"], "upc": ["0372603147018"], "unii": ["NWQ5N31VKK"], "rxcui": ["1996246"], "spl_set_id": ["01f3f32a-fac1-4a8f-b205-4601046f0b5c"], "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 (72603-147-01)  / 7 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "72603-147-01", "marketing_start_date": "20230418"}], "brand_name": "Daptomycin", "product_id": "72603-147_f9aa5759-84d0-be13-e053-6294a90af8c3", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Lipopeptide Antibacterial [EPC]", "Lipopeptides [CS]"], "product_ndc": "72603-147", "generic_name": "Daptomycin", "labeler_name": "NorthStar RxLLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Daptomycin", "active_ingredients": [{"name": "DAPTOMYCIN", "strength": "350 mg/7mL"}], "application_number": "ANDA216445", "marketing_category": "ANDA", "marketing_start_date": "20230418", "listing_expiration_date": "20261231"}