daptomycin

Generic: daptomycin

Labeler: accord healthcare, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

daptomycin 350 mg/7mL

Manufacturer
Accord Healthcare, Inc.

Identifiers & Regulatory

Product NDC 16729-434
Product ID 16729-434_40bc42f7-4d83-0e17-e063-6394a90ad5d2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212667
Listing Expiration 2026-12-31
Marketing Start 2019-07-16

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16729434
Hyphenated Format 16729-434

Supplemental Identifiers

RxCUI
1996246
UPC
0316729434058 0316729434454
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 ANDA212667 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 350 mg/7mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (16729-434-05) / 7 mL in 1 VIAL
  • 10 VIAL in 1 CARTON (16729-434-45) / 7 mL in 1 VIAL
source: ndc

Packages (2)

16729-434-05 1 VIAL in 1 CARTON (16729-434-05) / 7 mL in 1 VIAL 16729-434-45 10 VIAL in 1 CARTON (16729-434-45) / 7 mL in 1 VIAL

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": "40bc42f7-4d83-0e17-e063-6394a90ad5d2", "openfda": {"nui": ["N0000175509", "M0519359"], "upc": ["0316729434058", "0316729434454"], "unii": ["NWQ5N31VKK"], "rxcui": ["1996246"], "spl_set_id": ["f69e9306-ffac-41c9-b277-a6d784f2e341"], "pharm_class_cs": ["Lipopeptides [CS]"], "pharm_class_epc": ["Lipopeptide Antibacterial [EPC]"], "manufacturer_name": ["Accord Healthcare, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (16729-434-05)  / 7 mL in 1 VIAL", "package_ndc": "16729-434-05", "marketing_start_date": "20190716"}, {"sample": false, "description": "10 VIAL in 1 CARTON (16729-434-45)  / 7 mL in 1 VIAL", "package_ndc": "16729-434-45", "marketing_start_date": "20200227"}], "brand_name": "Daptomycin", "product_id": "16729-434_40bc42f7-4d83-0e17-e063-6394a90ad5d2", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Lipopeptide Antibacterial [EPC]", "Lipopeptides [CS]"], "product_ndc": "16729-434", "generic_name": "Daptomycin", "labeler_name": "Accord Healthcare, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Daptomycin", "active_ingredients": [{"name": "DAPTOMYCIN", "strength": "350 mg/7mL"}], "application_number": "ANDA212667", "marketing_category": "ANDA", "marketing_start_date": "20190716", "listing_expiration_date": "20261231"}