Triple Antibiotic

Product NDC
71927-003
11-digit product format
719270003
Labeler code
71927
Product ID
71927-003_d8c318c1-5787-0e62-e053-2a95a90a8618
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin Zinc, Neomycin Sulfate and Polymyxin B Sulfate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Orazen Inc
Application
part333B
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2018-07-12
Marketing end
0000-00-00
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
400 [USP'U]/g; mg/g; [USP'U]/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
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71927-003-02Triple Antibiotic1 in 1 CARTONOINTMENT13
71927-003-02Triple Antibiotic14.2 g in 1 TUBEOINTMENT14.23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71927-003TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE) OINTMENT [ORAZEN INC]3Legacy NDC, 2 package rows20220225_f9d698e2-a122-48bb-8298-38c55ef36874.zip

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 OintmentPSNf9d698e2-a122-48bb-8298-38c55ef368743
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCDf9d698e2-a122-48bb-8298-38c55ef368743
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSYf9d698e2-a122-48bb-8298-38c55ef368743

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71927-003-02719270003021 TUBE in 1 CARTON (71927-003-02) > 14.2 g in 1 TUBE1 tube2018-07-120000-00-00NoNoCurrent