FDA.reportPublic FDA data

Colistimethate

Product NDC
0143-9443
11-digit product format
001439443
Labeler code
0143
Product ID
0143-9443_a6b19fc2-67bd-4f3d-bcfa-155aeb0d4aca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Colistimethate Sodium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA205356
Marketing category
ANDA
Marketing start
2026-03-04
Substance
COLISTIMETHATE SODIUM
Active strength
150 mg/1
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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
COLISTIMETHATE SODIUM150 mg/1

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
0143-9443-01Colistimethate1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION17
0143-9443-01Colistimethate1 in 1 VIAL, GLASSINJECTION, POWDER, FOR SOLUTION17
0143-9443-12Colistimethate1 in 1 VIAL, GLASSINJECTION, POWDER, FOR SOLUTION17
0143-9443-12Colistimethate12 in 1 CARTONINJECTION, POWDER, FOR SOLUTION127

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9443-01EA - Each0143-94438dda4d0d-90e5-4fa6-a26c-70ce038fe66c12026-04-20
0143-9443-12EA - Each0143-94430092344d-9b97-4954-b60f-9eb05c7023a912026-04-20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1117522colistin 75 MG/ML Injectable SolutionPSNbf556f89-6373-45cb-b465-d991fde7eab97
1117522colistin 75 MG/ML Injectable SolutionSCDbf556f89-6373-45cb-b465-d991fde7eab97
1117522colistin (as colistimethate sodium) 75 MG/ML Injectable SolutionSYbf556f89-6373-45cb-b465-d991fde7eab97

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0143-9443-01001439443011 VIAL, GLASS in 1 CARTON (0143-9443-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS2026-03-04NoNoHistorical
0143-9443-120014394431212 VIAL, GLASS in 1 CARTON (0143-9443-12) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS2026-03-04NoNoHistorical