POLYMYXIN B

Product NDC
72266-249
11-digit product format
722660249
Labeler code
72266
Product ID
72266-249_3648864b-bfdb-b481-e063-6294a90a77b2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
POLYMYXIN B SULFATE
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS; OPHTHALMIC
Labeler
FOSUN PHARMA USA INC
Application
ANDA207322
Marketing category
ANDA
Marketing start
2023-08-31
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
72266-249-01POLYMYXIN B1 in 1 VIALINJECTION, POWDER, LYOPHILIZED,14
72266-249-10POLYMYXIN B10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72266-249POLYMYXIN B (POLYMYXIN B SULFATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FOSUN PHARMA USA INC]3Current NDC, 2 package rows20241116_fd664927-db58-a1af-e053-6294a90a9048.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204509polymyxin B Variable Concentration Multi-Use Injectable SolutionPSNfd664927-db58-a1af-e053-6294a90a90484
204509polymyxin B 250000 UNT/ML Injectable SolutionSCDfd664927-db58-a1af-e053-6294a90a90484

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72266-249-01722660249011 in 1 VIALHistorical
72266-249-107226602491010 VIAL in 1 CARTON (72266-249-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (72266-249-01) 10 vial2023-08-31NoNoHistorical