daptomycin

Generic: daptomycin

Labeler: hainan poly pharm., co., ltd.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name daptomycin
Generic Name daptomycin
Labeler hainan poly pharm., co., ltd.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
Routes
INTRAVENOUS
Active Ingredients

daptomycin 500 mg/20mL

Manufacturer
Hainan Poly Pharm., Co., Ltd.

Identifiers & Regulatory

Product NDC 14335-120
Product ID 14335-120_0a1a4553-120c-b67d-e063-6294a90a0572
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215890
Listing Expiration 2026-12-31
Marketing Start 2023-11-14

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 14335120
Hyphenated Format 14335-120

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 ANDA215890 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/20mL
source: ndc
Packaging
  • 20 mL in 1 VIAL, SINGLE-DOSE (14335-120-01)
source: ndc

Packages (1)

14335-120-01 20 mL in 1 VIAL, SINGLE-DOSE (14335-120-01)

Ingredients (1)

daptomycin (500 mg/20mL)

Linked Drug Pages (1)

daptomycin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "0a1a4553-120c-b67d-e063-6294a90a0572", "openfda": {"nui": ["N0000175509", "M0519359"], "unii": ["NWQ5N31VKK"], "rxcui": ["403920"], "spl_set_id": ["6ec53f7e-9a5f-4b24-84e9-c94325750e32"], "pharm_class_cs": ["Lipopeptides [CS]"], "pharm_class_epc": ["Lipopeptide Antibacterial [EPC]"], "manufacturer_name": ["Hainan Poly Pharm., Co., Ltd."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 mL in 1 VIAL, SINGLE-DOSE (14335-120-01)", "package_ndc": "14335-120-01", "marketing_start_date": "20231114"}], "brand_name": "daptomycin", "product_id": "14335-120_0a1a4553-120c-b67d-e063-6294a90a0572", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION", "pharm_class": ["Lipopeptide Antibacterial [EPC]", "Lipopeptides [CS]"], "product_ndc": "14335-120", "generic_name": "daptomycin", "labeler_name": "Hainan Poly Pharm., Co., Ltd.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "daptomycin", "active_ingredients": [{"name": "DAPTOMYCIN", "strength": "500 mg/20mL"}], "application_number": "ANDA215890", "marketing_category": "ANDA", "marketing_start_date": "20231114", "listing_expiration_date": "20261231"}