FDA.reportPublic FDA data

ANCALIMA

Product NDC
73014-3025
11-digit product format
730143025
Labeler code
73014
Product ID
73014-3025_b8b4c69a-ed0d-78b1-e053-2a95a90ade8b
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin Zinc Neomycin Sulfate Polymyxin B Sulfate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
ANCALIMA LIFESCIENCES LIMITED
Application
part333B
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2019-04-08
Marketing end
0000-00-00
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
400 [USP'U]/g; mg/g; [USP'U]/g
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73014-3025-22023-01-30C16284748780-1f386c649-fdc9-0266-e053-dadaa90a7c1aMedpride Triple Antibiotic
73014-3025-32023-01-30C16284748780-1f386c649-fdc9-0266-e053-dadaa90a7c1aMedpride Triple Antibiotic
73014-3025-42023-01-30C16284748780-1f386c649-fdc9-0266-e053-dadaa90a7c1aMedpride Triple Antibiotic
73014-3025-52023-01-30C16284748780-1f386c649-fdc9-0266-e053-dadaa90a7c1aMedpride Triple Antibiotic

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73014-3025-2ANCALIMAFirst Aid0.5 g in 1 PACKETOINTMENT0.52
73014-3025-3ANCALIMAFirst Aid0.9 g in 1 PACKETOINTMENT0.92
73014-3025-4ANCALIMAFirst Aid14 g in 1 TUBEOINTMENT142
73014-3025-5ANCALIMAFirst Aid28.3 g in 1 TUBEOINTMENT28.32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73014-3025ANCALIMA FIRST AID (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE) OINTMENT [ANCALIMA LIFESCIENCES LIMITED]2Legacy NDC, 4 package rows20210113_860ecb50-9cbb-fe33-e053-2991aa0a744b.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 OintmentPSN860ecb50-9cbb-fe33-e053-2991aa0a744b2
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD860ecb50-9cbb-fe33-e053-2991aa0a744b2
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY860ecb50-9cbb-fe33-e053-2991aa0a744b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
73014-3025-273014302502.5 g in 1 PACKET (73014-3025-2) 2019-04-080000-00-00NoNoCurrent
73014-3025-373014302503.9 g in 1 PACKET (73014-3025-3) 2019-04-080000-00-00NoNoCurrent
73014-3025-47301430250414 g in 1 TUBE (73014-3025-4) 14 g2019-04-080000-00-00NoNoCurrent
73014-3025-57301430250528.3 g in 1 TUBE (73014-3025-5) 28.3 g2019-04-080000-00-00NoNoCurrent