daptomycin

Generic: daptomycin

Labeler: be pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

daptomycin 350 mg/7mL

Manufacturer
BE Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 71839-108
Product ID 71839-108_9b7e93ce-5bc1-4018-85cc-9746ce516e69
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213425
Listing Expiration 2026-12-31
Marketing Start 2020-08-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71839108
Hyphenated Format 71839-108

Supplemental Identifiers

RxCUI
1996246
UPC
0371839108015
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 ANDA213425 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 350 mg/7mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (71839-108-01) / 7 mL in 1 VIAL
  • 10 VIAL in 1 CARTON (71839-108-10) / 7 mL in 1 VIAL
source: ndc

Packages (2)

71839-108-01 1 VIAL in 1 CARTON (71839-108-01) / 7 mL in 1 VIAL 71839-108-10 10 VIAL in 1 CARTON (71839-108-10) / 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": "9b7e93ce-5bc1-4018-85cc-9746ce516e69", "openfda": {"nui": ["N0000175509", "M0519359"], "upc": ["0371839108015"], "unii": ["NWQ5N31VKK"], "rxcui": ["1996246"], "spl_set_id": ["c305bc9f-8aeb-40de-8492-154929764daf"], "pharm_class_cs": ["Lipopeptides [CS]"], "pharm_class_epc": ["Lipopeptide Antibacterial [EPC]"], "manufacturer_name": ["BE Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (71839-108-01)  / 7 mL in 1 VIAL", "package_ndc": "71839-108-01", "marketing_start_date": "20200820"}, {"sample": false, "description": "10 VIAL in 1 CARTON (71839-108-10)  / 7 mL in 1 VIAL", "package_ndc": "71839-108-10", "marketing_start_date": "20200820"}], "brand_name": "daptomycin", "product_id": "71839-108_9b7e93ce-5bc1-4018-85cc-9746ce516e69", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Lipopeptide Antibacterial [EPC]", "Lipopeptides [CS]"], "product_ndc": "71839-108", "generic_name": "daptomycin", "labeler_name": "BE Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "daptomycin", "active_ingredients": [{"name": "DAPTOMYCIN", "strength": "350 mg/7mL"}], "application_number": "ANDA213425", "marketing_category": "ANDA", "marketing_start_date": "20200820", "listing_expiration_date": "20261231"}