Bacitracin Zinc and Polymyxin B Sulfate

Product NDC
68788-7599
11-digit product format
687887599
Labeler code
68788
Product ID
68788-7599_fbc413a0-6310-42e2-8860-13615240c362
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bacitracin Zinc and Polymyxin B Sulfate
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA064046
Marketing category
ANDA
Marketing start
2020-03-27
Marketing end
0000-00-00
Substance
BACITRACIN ZINC; POLYMYXIN B SULFATE
Active strength
500 [USP'U]/g; [USP'U]/g
Pharmacologic classes
Decreased Cell Wall Synthesis & Repair [PE], 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
68788-7599-3GM - Gram68788-7599177dcb01-b243-41eb-89de-695e982c0f0d12020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7599BACITRACIN ZINC AND POLYMYXIN B SULFATE OINTMENT [PREFERRED PHARMACEUTICALS INC.]6Legacy NDC20250207_e6447ebb-9224-4a3e-ad74-0c923414aa07.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7599-3687887599031 TUBE in 1 CARTON (68788-7599-3) > 3.5 g in 1 TUBE1 tube2020-03-270000-00-00NoNoCurrent