Neomycin and Polymyxin B Sulfates and Bacitracin Zinc

Product NDC
16571-754
11-digit product format
165710754
Labeler code
16571
Product ID
16571-754_48173c90-79ed-459d-b259-947bc7952c13
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Neomycin and Polymyxin B Sulfates and Bacitracin Zinc
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
Rising Pharma Holdings, Inc.
Application
NDA050417
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2017-04-07
Marketing end
0000-00-00
Substance
NEOMYCIN SULFATE; POLYMYXIN B SULFATE; BACITRACIN ZINC
Active strength
4 mg/g; [USP'U]/g; [USP'U]/g
Pharmacologic classes
Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Polymyxin-class Antibacterial [EPC],Polymyxins [CS],Decreased Cell Wall Synthesis & Repair [PE]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-754-53GM - Gram16571-754cafe3402-a8f4-4adc-bd88-219b8c236c7812021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-754NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC OINTMENT [RISING PHARMA HOLDINGS, INC.]1Legacy NDC20211117_48173c90-79ed-459d-b259-947bc7952c13.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16571-754-53165710754531 TUBE in 1 CARTON (16571-754-53) > 3.5 g in 1 TUBE1 tube2021-11-010000-00-00NoNoCurrent