daptomycin

Generic: daptomycin

Labeler: dr. reddy's laboratories inc.,
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name daptomycin
Generic Name daptomycin
Labeler dr. reddy's laboratories inc.,
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

daptomycin 350 mg/7mL

Manufacturer
Dr. Reddy's Laboratories Inc.,

Identifiers & Regulatory

Product NDC 43598-476
Product ID 43598-476_29677998-337b-a026-92f5-1a3958dec926
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211403
Listing Expiration 2026-12-31
Marketing Start 2021-10-04

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43598476
Hyphenated Format 43598-476

Supplemental Identifiers

RxCUI
1996246
UPC
0343598476117
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 ANDA211403 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 350 mg/7mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (43598-476-11) / 7 mL in 1 VIAL, SINGLE-DOSE
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (43598-476-58) / 7 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (2)

43598-476-11 1 VIAL, SINGLE-DOSE in 1 CARTON (43598-476-11) / 7 mL in 1 VIAL, SINGLE-DOSE 43598-476-58 10 VIAL, SINGLE-DOSE in 1 CARTON (43598-476-58) / 7 mL in 1 VIAL, SINGLE-DOSE

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": "29677998-337b-a026-92f5-1a3958dec926", "openfda": {"nui": ["N0000175509", "M0519359"], "upc": ["0343598476117"], "unii": ["NWQ5N31VKK"], "rxcui": ["1996246"], "spl_set_id": ["d750e28d-1353-4671-66a3-ea4e49e81e7b"], "pharm_class_cs": ["Lipopeptides [CS]"], "pharm_class_epc": ["Lipopeptide Antibacterial [EPC]"], "manufacturer_name": ["Dr. Reddy's Laboratories Inc.,"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (43598-476-11)  / 7 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "43598-476-11", "marketing_start_date": "20211004"}, {"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (43598-476-58)  / 7 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "43598-476-58", "marketing_start_date": "20211004"}], "brand_name": "Daptomycin", "product_id": "43598-476_29677998-337b-a026-92f5-1a3958dec926", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Lipopeptide Antibacterial [EPC]", "Lipopeptides [CS]"], "product_ndc": "43598-476", "generic_name": "Daptomycin", "labeler_name": "Dr. Reddy's Laboratories Inc.,", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Daptomycin", "active_ingredients": [{"name": "DAPTOMYCIN", "strength": "350 mg/7mL"}], "application_number": "ANDA211403", "marketing_category": "ANDA", "marketing_start_date": "20211004", "listing_expiration_date": "20261231"}