daptomycin

Generic: daptomycin

Labeler: qilu pharmaceutical co., ltd.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name daptomycin
Generic Name daptomycin
Labeler qilu pharmaceutical co., ltd.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

daptomycin 500 mg/10mL

Manufacturer
Qilu Pharmaceutical Co., Ltd.

Identifiers & Regulatory

Product NDC 67184-0549
Product ID 67184-0549_77549b99-ead5-4148-a1b1-e1b66e9da5ea
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215316
Listing Expiration 2026-12-31
Marketing Start 2021-08-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 671840549
Hyphenated Format 67184-0549

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 ANDA215316 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/10mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-USE in 1 CARTON (67184-0549-1) / 10 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (1)

67184-0549-1 1 VIAL, SINGLE-USE in 1 CARTON (67184-0549-1) / 10 mL in 1 VIAL, SINGLE-USE

Ingredients (1)

daptomycin (500 mg/10mL)

Linked Drug Pages (1)

Daptomycin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "77549b99-ead5-4148-a1b1-e1b66e9da5ea", "openfda": {"nui": ["N0000175509", "M0519359"], "unii": ["NWQ5N31VKK"], "rxcui": ["403920"], "spl_set_id": ["e32c7141-fbd9-47c8-bd1e-94b880b2c5a6"], "pharm_class_cs": ["Lipopeptides [CS]"], "pharm_class_epc": ["Lipopeptide Antibacterial [EPC]"], "manufacturer_name": ["Qilu Pharmaceutical Co., Ltd."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-USE in 1 CARTON (67184-0549-1)  / 10 mL in 1 VIAL, SINGLE-USE", "package_ndc": "67184-0549-1", "marketing_start_date": "20210824"}], "brand_name": "Daptomycin", "product_id": "67184-0549_77549b99-ead5-4148-a1b1-e1b66e9da5ea", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Lipopeptide Antibacterial [EPC]", "Lipopeptides [CS]"], "product_ndc": "67184-0549", "generic_name": "Daptomycin", "labeler_name": "Qilu Pharmaceutical Co., Ltd.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Daptomycin", "active_ingredients": [{"name": "DAPTOMYCIN", "strength": "500 mg/10mL"}], "application_number": "ANDA215316", "marketing_category": "ANDA", "marketing_start_date": "20210824", "listing_expiration_date": "20261231"}