Triple Antibiotic

Product NDC
50382-023
11-digit product format
503820023
Labeler code
50382
Product ID
50382-023_ee230c74-5dfe-eea5-e053-2a95a90a4cab
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Galentic Pharma (India) Private Limited
Application
part333B
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-08-07
Marketing end
0000-00-00
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
400 [iU]/g; mg/g; [iU]/g
Pharmacologic classes
Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], 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 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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204602bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical OintmentPSNe55cbf7e-c955-7f1a-e053-2a95a90a3f282
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCDe55cbf7e-c955-7f1a-e053-2a95a90a3f282
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSYe55cbf7e-c955-7f1a-e053-2a95a90a3f282

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50382-023-045038200230425 PACKET in 1 CARTON (50382-023-04) > .5 g in 1 PACKET25 packet2013-08-070000-00-00NoNoCurrent
50382-023-1150382002311144 PACKET in 1 CARTON (50382-023-11) > .9 g in 1 PACKET144 packet2017-08-070000-00-00NoNoCurrent
50382-023-12503820023121 TUBE in 1 CARTON (50382-023-12) > 14.2 g in 1 TUBE1 tube2013-08-070000-00-00NoNoCurrent
50382-023-13503820023131 TUBE in 1 CARTON (50382-023-13) > 28 g in 1 TUBE1 tube2013-08-070000-00-00NoNoCurrent
50382-023-215038200232125 PACKET in 1 CARTON (50382-023-21) > .9 g in 1 PACKET25 packet2013-08-070000-00-00NoNoCurrent