POLYMYXIN B

Product NDC
45932-0030
11-digit product format
459320030
Labeler code
45932
Product ID
45932-0030_5039c2fa-cc43-4787-933c-a9943ca381eb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
POLYMYXIN B SULFATE
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS
Labeler
Xellia Pharmaceuticals ApS
Application
ANDA202766
Marketing category
ANDA
Marketing start
2014-01-24
Marketing end
0000-00-00
Substance
POLYMYXIN B SULFATE
Active strength
500000 1/1
Pharmacologic classes
Polymyxin-class Antibacterial [EPC],Polymyxins [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45932-0030-1POLYMYXIN B1 in 1 VIALINJECTION13
45932-0030-1POLYMYXIN B10 in 1 CARTONINJECTION103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45932-0030POLYMYXIN B (POLYMYXIN B SULFATE) INJECTION [XELLIA PHARMACEUTICALS APS]3Legacy NDC, 2 package rows20160218_132fe072-9c9a-4c56-9004-c27ee6a467ae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204509polymyxin B Variable Concentration Multi-Use Injectable SolutionPSN132fe072-9c9a-4c56-9004-c27ee6a467ae3
204509polymyxin B 250000 UNT/ML Injectable SolutionSCD132fe072-9c9a-4c56-9004-c27ee6a467ae3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
45932-0030-1459320030011 in 1 VIALHistorical