daptomycin in sodium chloride (0338-0716)

Drug Facts

Product Profile

Brand Name daptomycin in sodium chloride

Generic Name daptomycin in sodium chloride

Labeler baxter healthcare corporation

Dosage Form INJECTION, SOLUTION

Routes

INTRAVENOUS

Active Ingredients

daptomycin 700 mg/100mL

Manufacturer

Baxter Healthcare Corporation

Identifiers & Regulatory

Product NDC 0338-0716

Product ID 0338-0716_7b6f75eb-02dd-4906-9ee1-4c658a5e36b3

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category NDA

Application Number NDA213645

Listing Expiration 2027-12-31

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 03380716

Hyphenated Format 0338-0716

Supplemental Identifiers

RxCUI

2632127 2632130 2632132 2632133

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 in sodium chloride (source: ndc)

Generic Name daptomycin in sodium chloride (source: ndc)

Application Number NDA213645 (source: ndc)

Routes

INTRAVENOUS

source: ndc

Resolved Composition

Strengths

700 mg/100mL

source: ndc

Packaging

12 BAG in 1 CARTON (0338-0716-12) / 100 mL in 1 BAG

source: ndc

Packages (1)

0338-0716-12 12 BAG in 1 CARTON (0338-0716-12) / 100 mL in 1 BAG

Ingredients (1)

daptomycin (700 mg/100mL)

Linked Drug Pages (1)

Daptomycin in Sodium Chloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["INTRAVENOUS"], "spl_id": "7b6f75eb-02dd-4906-9ee1-4c658a5e36b3", "openfda": {"nui": ["N0000175509", "M0519359"], "unii": ["NWQ5N31VKK"], "rxcui": ["2632127", "2632130", "2632132", "2632133"], "spl_set_id": ["7ed4d986-2aa9-43cd-9a8a-fbd11cb5ecef"], "pharm_class_cs": ["Lipopeptides [CS]"], "pharm_class_epc": ["Lipopeptide Antibacterial [EPC]"], "manufacturer_name": ["Baxter Healthcare Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 BAG in 1 CARTON (0338-0716-12)  / 100 mL in 1 BAG", "package_ndc": "0338-0716-12", "marketing_start_date": "20230227"}], "brand_name": "Daptomycin in Sodium Chloride", "product_id": "0338-0716_7b6f75eb-02dd-4906-9ee1-4c658a5e36b3", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Lipopeptide Antibacterial [EPC]", "Lipopeptides [CS]"], "product_ndc": "0338-0716", "generic_name": "Daptomycin in Sodium Chloride", "labeler_name": "Baxter Healthcare Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Daptomycin in Sodium Chloride", "active_ingredients": [{"name": "DAPTOMYCIN", "strength": "700 mg/100mL"}], "application_number": "NDA213645", "marketing_category": "NDA", "marketing_start_date": "20220125", "listing_expiration_date": "20271231"}