Colistimethate

Product NDC
39822-0615
11-digit product format
398220615
Labeler code
39822
Product ID
39822-0615_eedca302-5a83-6a5c-e053-2a95a90a7144
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Colistimethate
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
XGen Pharmaceuticals DJB, Inc.
Application
ANDA064216
Marketing category
ANDA
Marketing start
2011-01-01
Marketing end
0000-00-00
Substance
COLISTIMETHATE SODIUM
Active strength
150 mg/2mL
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
39822-0615-1EA - Each39822-061589dc5ae6-32bf-4179-81e4-881f6b8e0b3e12012-07-24
39822-0615-2EA - Each39822-0615c62bf5b1-30ec-40ff-b10c-db6fe3bff98a12013-02-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
39822-0615-23982206150212 CARTON in 1 CARTON (39822-0615-2) > 1 VIAL in 1 CARTON (39822-0615-1) > 2 mL in 1 VIAL12 carton2011-01-010000-00-00NoNoCurrent