Polymyxin B

Product NDC
39822-0166
11-digit product format
398220166
Labeler code
39822
Product ID
39822-0166_eedc47c0-5580-3069-e053-2995a90a0226
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Polymyxin B
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS; OPHTHALMIC
Labeler
XGen Pharmaceuticals DJB, Inc.
Application
ANDA063000
Marketing category
ANDA
Marketing start
1994-09-30
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
39822-0166-5EA - Each39822-01663654b76a-9309-4ddd-b43b-26b934b43c0f12012-07-24
39822-0166-7EA - Each39822-016689ba6e6e-ea54-4672-9bb0-7503cf55d6ed12013-02-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
39822-0166-5398220166051 VIAL in 1 CARTON (39822-0166-5) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL1 vial1994-09-300000-00-00NoNoCurrent
39822-0166-7398220166071 VIAL in 1 CARTON (39822-0166-7) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL1 vial1994-09-300000-00-00NoNoCurrent