Polymyxin B

Product NDC
0143-9941
11-digit product format
001439941
Labeler code
0143
Product ID
0143-9941_dc529b6b-bbf4-44da-a829-f506c41d47f6
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
ANDA060716
Marketing category
ANDA
Marketing start
1998-06-01
Substance
POLYMYXIN B SULFATE
Active strength
500000 [iU]/1
Pharmacologic classes
Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Polymyxin B
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POLYMYXIN B SULFATE500000 [iU]/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
0143-9941-01Polymyxin B1 in 1 VIALINJECTION, POWDER, FOR SOLUTION13
0143-9941-10Polymyxin B10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9941POLYMYXIN B (POLYMYXIN B SULFATE) INJECTION, POWDER, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.]3Current NDC, Legacy NDC, 2 package rows20220429_18daf0d1-b6f5-46f4-ab2f-01a594f3959c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204509polymyxin B Variable Concentration Multi-Use Injectable SolutionPSN18daf0d1-b6f5-46f4-ab2f-01a594f3959c3
204509polymyxin B 250000 UNT/ML Injectable SolutionSCD18daf0d1-b6f5-46f4-ab2f-01a594f3959c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9941-01001439941011 in 1 VIALHistorical
0143-9941-100014399411010 VIAL in 1 CARTON (0143-9941-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9941-01) 10 vial1998-06-010000-00-00NoNoCurrent