FDA.reportPublic FDA data

Polymyxin B

Product NDC
0143-9461
11-digit product format
001439461
Labeler code
0143
Product ID
0143-9461_d87f8155-092a-4dd0-8325-417a0ed8f167
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Polymyxin B Sulfate
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS; OPHTHALMIC
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA202766
Marketing category
ANDA
Marketing start
2025-09-30
Substance
POLYMYXIN B SULFATE
Active strength
500000 [USP'U]/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
Polymyxin B
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POLYMYXIN B SULFATE500000 [USP'U]/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii19371312D4
Rxcui204509

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9461-01Polymyxin B1 in 1 VIAL, GLASSINJECTION, POWDER, FOR SOLUTION113
0143-9461-01Polymyxin B1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION113
0143-9461-10Polymyxin B10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION1013
0143-9461-10Polymyxin B1 in 1 VIAL, GLASSINJECTION, POWDER, FOR SOLUTION113

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9461-01EA - Each0143-9461c60732d4-4a7c-4fa5-90a1-f5050a703fca12025-11-13
0143-9461-10EA - Each0143-94619de5214d-99f8-435a-9c55-c72d9c81235912025-11-13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204509polymyxin B Variable Concentration Multi-Use Injectable SolutionPSNd2bf65f6-2763-4859-a665-ad5e6cde71ee13
204509polymyxin B 250000 UNT/ML Injectable SolutionSCDd2bf65f6-2763-4859-a665-ad5e6cde71ee13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0143-9461-01001439461011 VIAL, GLASS in 1 CARTON (0143-9461-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS2025-09-30NoNoCurrent
0143-9461-100014394611010 VIAL, GLASS in 1 CARTON (0143-9461-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS2025-09-30NoNoCurrent