colistimethate sodium

Generic: colistimethate sodium

Labeler: heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name colistimethate sodium
Generic Name colistimethate sodium
Labeler heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

colistimethate sodium 150 mg/4mL

Manufacturer
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 23155-193
Product ID 23155-193_698b0d4f-1182-475f-aafb-bfcbd0b637f2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202359
Listing Expiration 2027-12-31
Marketing Start 2021-09-09

Pharmacologic Class

Classes
polymyxin-class antibacterial [epc] polymyxins [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 23155193
Hyphenated Format 23155-193

Supplemental Identifiers

RxCUI
1117522
UPC
0323155193312
UNII
XW0E5YS77G

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 colistimethate sodium (source: ndc)
Generic Name colistimethate sodium (source: ndc)
Application Number ANDA202359 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 150 mg/4mL
source: ndc
Packaging
  • 1 VIAL, GLASS in 1 CARTON (23155-193-31) / 4 mL in 1 VIAL, GLASS
  • 12 VIAL, GLASS in 1 CARTON (23155-193-41) / 4 mL in 1 VIAL, GLASS
source: ndc

Packages (2)

23155-193-31 1 VIAL, GLASS in 1 CARTON (23155-193-31) / 4 mL in 1 VIAL, GLASS 23155-193-41 12 VIAL, GLASS in 1 CARTON (23155-193-41) / 4 mL in 1 VIAL, GLASS

Ingredients (1)

colistimethate sodium (150 mg/4mL)

Linked Drug Pages (1)

COLISTIMETHATE SODIUM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "698b0d4f-1182-475f-aafb-bfcbd0b637f2", "openfda": {"upc": ["0323155193312"], "unii": ["XW0E5YS77G"], "rxcui": ["1117522"], "spl_set_id": ["6a335659-03b0-4a2d-9cd4-7dcf7da96fe6"], "manufacturer_name": ["Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 CARTON (23155-193-31)  / 4 mL in 1 VIAL, GLASS", "package_ndc": "23155-193-31", "marketing_start_date": "20210909"}, {"sample": false, "description": "12 VIAL, GLASS in 1 CARTON (23155-193-41)  / 4 mL in 1 VIAL, GLASS", "package_ndc": "23155-193-41", "marketing_start_date": "20210909"}], "brand_name": "COLISTIMETHATE SODIUM", "product_id": "23155-193_698b0d4f-1182-475f-aafb-bfcbd0b637f2", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Polymyxin-class Antibacterial [EPC]", "Polymyxins [CS]"], "product_ndc": "23155-193", "generic_name": "COLISTIMETHATE SODIUM", "labeler_name": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "COLISTIMETHATE SODIUM", "active_ingredients": [{"name": "COLISTIMETHATE SODIUM", "strength": "150 mg/4mL"}], "application_number": "ANDA202359", "marketing_category": "ANDA", "marketing_start_date": "20210909", "listing_expiration_date": "20271231"}