Polymyxin B

Product NDC
55150-234
11-digit product format
551500234
Labeler code
55150
Product ID
55150-234_097fa44b-506b-4ee0-9f64-4b560c3ed41c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Polymyxin B
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS; OPHTHALMIC
Labeler
Eugia US LLC
Application
ANDA206589
Marketing category
ANDA
Marketing start
2016-04-04
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
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 [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
55150-234-10Polymyxin B1 in 1 VIALINJECTION, POWDER, LYOPHILIZED,17
55150-234-10Polymyxin B10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55150-234-10EA - Each55150-2340aac51ef-8fdf-487e-b6db-f9e05b0780c112017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-234POLYMYXIN B INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [EUGIA US LLC]7Current NDC, Legacy NDC, 2 package rows20250515_a974c557-e88f-451b-a1bd-d2c656be226e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204509polymyxin B Variable Concentration Multi-Use Injectable SolutionPSNa974c557-e88f-451b-a1bd-d2c656be226e7
204509polymyxin B 250000 UNT/ML Injectable SolutionSCDa974c557-e88f-451b-a1bd-d2c656be226e7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55150-234-105515002341010 VIAL in 1 CARTON (55150-234-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL10 vial2016-04-040000-00-00NoNoCurrent