dapzura rt

Generic: daptomycin

Labeler: baxter healthcare corporation
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name dapzura rt
Generic Name daptomycin
Labeler baxter healthcare corporation
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

daptomycin 500 mg/10mL

Manufacturer
Baxter Healthcare Corporation

Identifiers & Regulatory

Product NDC 60977-145
Product ID 60977-145_b62c0b44-b534-4364-8776-811b0df198ba
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA213645
Listing Expiration 2026-12-31
Marketing Start 2022-01-25

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 60977145
Hyphenated Format 60977-145

Supplemental Identifiers

RxCUI
403920 2591793
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 dapzura rt (source: ndc)
Generic Name daptomycin (source: ndc)
Application Number NDA213645 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/10mL
source: ndc
Packaging
  • 16 HOW SUPPLIED/STORAGE AND HANDLING DAPZURA RT (daptomycin for injection) is supplied as a sterile pale yellow to light brown lyophilized powder in a single-dose 10 mL vial containing 500 mg of daptomycin: Package of 1 (NDC 60977-145-01). The vial stopper is not made with natural rubber latex. Store original packages at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Storage conditions for the reconstituted and diluted solutions are described in another section of the prescribing information [see Dosage and Administration (2.7) ] .
  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Container Label Barcode (FPO) Use 10 mL Sterile or Bacte- riostatic Water for Injection for reconstitution only. NDC 60977- 145 -01 Rx Only Store at 20°C to 25°C (68°F to 77°F). See package insert for Usual Dosage and storage of reconstituted and further diluted product. 07-09-00-0427 Baxter Healthcare Corporation DAPZURA RT (daptomycin for injection) 500 mg per vial For Intravenous Use Single-dose vial – Discard Unused Portion Baxter Logo Lot: (FPO) Exp.: (FPO) Carton Label For Intravenous Use Rx Only Single-dose vial – Discard Unused Portion Baxter Logo 2D Barcode Location DAPZURA RT (daptomycin for injection) 500 mg per vial NDC 60977- 145 -01 DAPZURA RT (daptomycin for injection) 500 mg per vial For Intravenous Use Reconstitute viral only with Sterile Water for Injection or Bacteriostatic Water for Injection. Single-dose vial - Discard Unused Portion 1D Barcode (01) 20360977145017 Recommended Dosage: See Prescribing Information. This package contains one single-dose vial of sterile DAPZURA RT (daptomycin for injection) and one package insert. Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP controlled Room Temperature.] See package insert for storage of reconstituted and further diluted product. Not made with Natural rubber latex Baxter Logo Baxter Healthcare Corporation Deerfield, IL 60015 Made in the USA 2VR500 07-01-00-0894 3-6118-520 NDC 60977- 145 -01 DAPZURA RT (daptomycin for injection) 500 mg per vial For Intravenous Use Reconstitute viral only with Sterile Water for Injection or Bacteriostatic Water for Injection. Single-dose vial - Discard Unused Portion Rx Only Baxter Logo FPO 2D Barcode location See enclosed package insert for reconstitution instructions and complete information on dosage and administration. DAPZURA RT (daptomycin for injection) contains 500 mg/vial of daptomycin. Reconstitute with 10 mL Sterile Water for Injection or Bacteriostatic Water for Injection to obtain a final concentration of 50 mg/mL. Each vial also contains 238 mg sorbitol and 238 mg of mannitol. Sodium hydroxide and/or hydrochloric acid are used to adjust pH. Contains no preservatives. Note: Parenteral drug products should be inspected visually for particulate matter prior to administration. Daptomycin Representative Container Label 60977-145-01 Daptomycin Representative Carton Label 60977-145-01 1 of 2 Daptomycin Representative Carton Label 60977-145-01 2 of 2
source: label

Packages (0)

No package records.

Ingredients (1)

daptomycin (500 mg/10mL)

Linked Drug Pages (1)

DAPZURA RT ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "b62c0b44-b534-4364-8776-811b0df198ba", "openfda": {"nui": ["N0000175509", "M0519359"], "unii": ["NWQ5N31VKK"], "rxcui": ["403920", "2591793"], "spl_set_id": ["cb1283e1-35b8-425c-b338-d9ac0c7161f8"], "pharm_class_cs": ["Lipopeptides [CS]"], "pharm_class_epc": ["Lipopeptide Antibacterial [EPC]"], "manufacturer_name": ["Baxter Healthcare Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "DAPZURA RT", "product_id": "60977-145_b62c0b44-b534-4364-8776-811b0df198ba", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Lipopeptide Antibacterial [EPC]", "Lipopeptides [CS]"], "product_ndc": "60977-145", "generic_name": "daptomycin", "labeler_name": "Baxter Healthcare Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DAPZURA RT", "active_ingredients": [{"name": "DAPTOMYCIN", "strength": "500 mg/10mL"}], "application_number": "NDA213645", "marketing_category": "NDA", "marketing_start_date": "20220125", "listing_expiration_date": "20261231"}