FDA.reportPublic FDA data

COLISTIMETHATE SODIUM

Product NDC
23155-193
11-digit product format
231550193
Labeler code
23155
Product ID
23155-193_698b0d4f-1182-475f-aafb-bfcbd0b637f2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
COLISTIMETHATE SODIUM
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA202359
Marketing category
ANDA
Marketing start
2021-09-09
Substance
COLISTIMETHATE SODIUM
Active strength
150 mg/4mL
Pharmacologic classes
Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
COLISTIMETHATE SODIUM
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
COLISTIMETHATE SODIUM150 mg/4mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiXW0E5YS77G
Rxcui1117522

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f304a07f-cb4d-4a13-bc6d-a0095b865f96Product name120150611

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23155-193-31COLISTIMETHATE SODIUM1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,118
23155-193-31COLISTIMETHATE SODIUM4 mL in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,418
23155-193-41COLISTIMETHATE SODIUM12 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,1218
23155-193-41COLISTIMETHATE SODIUM4 mL in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,418

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-193-31EA - Each23155-1937c9fa0f6-5395-44dc-aa84-20bfc5c6717712013-02-13
23155-193-41EA - Each23155-193796076fa-a2de-4533-988b-88c2fdc0141412021-11-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
COLISTIMETHATE SODIUMACTIVE INGREDIENTXW0E5YS77GCOLISTIMETHATE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HERITAGE PHARMACEUTICALS INC.]7
COLISTIMETHATEACTIVE MOIETYDL2R53P963COLISTIMETHATE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HERITAGE PHARMACEUTICALS INC.]7
WATERINACTIVE INGREDIENT059QF0KO0RCOLISTIMETHATE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HERITAGE PHARMACEUTICALS INC.]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-193COLISTIMETHATE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]17Current NDC, Legacy NDC, 4 package rows20250406_6a335659-03b0-4a2d-9cd4-7dcf7da96fe6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1117522colistin 75 MG/ML Injectable SolutionPSN6a335659-03b0-4a2d-9cd4-7dcf7da96fe618
1117522colistin 75 MG/ML Injectable SolutionSCD6a335659-03b0-4a2d-9cd4-7dcf7da96fe618
1117522colistin (as colistimethate sodium) 75 MG/ML Injectable SolutionSY6a335659-03b0-4a2d-9cd4-7dcf7da96fe618

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
23155-193-31231550193311 VIAL, GLASS in 1 CARTON (23155-193-31) / 4 mL in 1 VIAL, GLASS2021-09-090000-00-00NoNoCurrent
23155-193-412315501934112 VIAL, GLASS in 1 CARTON (23155-193-41) / 4 mL in 1 VIAL, GLASS2021-09-090000-00-00NoNoCurrent