0338-0716 NDC - DAPTOMYCIN IN SODIUM CHLORIDE

Drug Information

  • Product NDC: 0338-0716
  • Proprietary Name: Daptomycin in Sodium Chloride
  • Non Proprietary Name: Daptomycin in Sodium Chloride
  • Active Ingredient(s): 700 mg/100mL DAPTOMYCIN
  • Administration Route(s): INTRAVENOUS
  • Dosage Form(s): INJECTION, SOLUTION
  • Pharmacy Class(es): Lipopeptide Antibacterial [EPC]; Lipopeptides [CS]

Labeler Information

Field Name Field Value
Labeler Name: Baxter Healthcare Corporation
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA213645
Marketing Category: NDA
Start Marketing Date:1/25/2022

Package Information

No. Package Code Package Description Billing Unit
10338-0716-1212 BAG in 1 CARTON (0338-0716-12) / 100 mL in 1 BAGML

NDC Record

Field Name Field Value Definition
PRODUCT NDC0338-0716The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGA suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard.
PROPRIETARY NAMEDaptomycin in Sodium ChlorideThis is the date that the labeler indicates was the start of its marketing of the drug product.
NON PROPRIETARY NAMEDaptomycin in Sodium ChlorideThis is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
DOSAGE FORM NAMEINJECTION, SOLUTIONProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
ROUTE NAMEINTRAVENOUSThis corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
START MARKETING DATE1/25/2022Name of Company corresponding to the labeler code segment of the Product NDC.
MARKETING CATEGORY NAMENDAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERNDA213645This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEBaxter Healthcare CorporationName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEDAPTOMYCINAn active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH700 
ACTIVE INGRED UNITmg/100mL 
PHARM CLASSESLipopeptide Antibacterial [EPC], Lipopeptides [CS] 

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This page was last updated on: 12/6/2025

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