daptomycin

Generic: daptomycin

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

Drug Facts

Product Profile

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

daptomycin 500 mg/10mL

Manufacturer
Hospira, Inc.

Identifiers & Regulatory

Product NDC 0409-0122
Product ID 0409-0122_82b124e9-01d4-4e8c-b9cc-0dec0dc282a5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA210282
Listing Expiration 2026-12-31
Marketing Start 2021-08-02

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04090122
Hyphenated Format 0409-0122

Supplemental Identifiers

RxCUI
403920 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 NDA210282 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/10mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0122-01) / 10 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

0409-0122-01 1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0122-01) / 10 mL in 1 VIAL, SINGLE-DOSE

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": "82b124e9-01d4-4e8c-b9cc-0dec0dc282a5", "openfda": {"nui": ["N0000175509", "M0519359"], "unii": ["NWQ5N31VKK"], "rxcui": ["403920", "1996246"], "spl_set_id": ["1957b6ce-7382-4a7b-bf02-3595948d09c6"], "pharm_class_cs": ["Lipopeptides [CS]"], "pharm_class_epc": ["Lipopeptide Antibacterial [EPC]"], "manufacturer_name": ["Hospira, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0122-01)  / 10 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0409-0122-01", "marketing_start_date": "20210802"}], "brand_name": "Daptomycin", "product_id": "0409-0122_82b124e9-01d4-4e8c-b9cc-0dec0dc282a5", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Lipopeptide Antibacterial [EPC]", "Lipopeptides [CS]"], "product_ndc": "0409-0122", "generic_name": "DAPTOMYCIN", "labeler_name": "Hospira, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Daptomycin", "active_ingredients": [{"name": "DAPTOMYCIN", "strength": "500 mg/10mL"}], "application_number": "NDA210282", "marketing_category": "NDA", "marketing_start_date": "20210802", "listing_expiration_date": "20261231"}