FDA.reportPublic FDA data

bacitracin zinc, neomycin sulfate and polymyxin b sulfate

Product NDC
50382-008
11-digit product format
503820008
Labeler code
50382
Product ID
50382-008_cae22cb8-66e4-4702-80c2-89428b37f1cc
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
NDC exclude flag
E
Listing certified through
2017-12-31
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
50382-008-012019-11-27C16284748780-19855d018-de38-cd31-e053-dbdaa90ab51aGalentic Triple Antibiotic Ointment
50382-008-022019-11-27C16284748780-19855d018-de38-cd31-e053-dbdaa90ab51aGalentic Triple Antibiotic Ointment
50382-008-032019-11-27C16284748780-19855d018-de38-cd31-e053-dbdaa90ab51aGalentic Triple Antibiotic Ointment
50382-008-042019-11-27C16284748780-19855d018-de38-cd31-e053-dbdaa90ab51aGalentic Triple Antibiotic Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50382-008-01bacitracin zinc, neomycin sulfate and polymyxin b sulfate28.35 g in 1 TUBEOINTMENT28.351
50382-008-02bacitracin zinc, neomycin sulfate and polymyxin b sulfate14.17 g in 1 TUBEOINTMENT14.171
50382-008-03bacitracin zinc, neomycin sulfate and polymyxin b sulfate56.7 g in 1 TUBEOINTMENT56.71
50382-008-04bacitracin zinc, neomycin sulfate and polymyxin b sulfate113.4 g in 1 TUBEOINTMENT113.41

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BACITRACIN ZINCACTIVE INGREDIENT89Y4M234ESBACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE OINTMENT [GALENTIC PHARMA (INDIA) PRIVATE LIMITED]1
NEOMYCIN SULFATEACTIVE INGREDIENT057Y626693BACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE OINTMENT [GALENTIC PHARMA (INDIA) PRIVATE LIMITED]1
POLYMYXIN B SULFATEACTIVE INGREDIENT19371312D4BACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE OINTMENT [GALENTIC PHARMA (INDIA) PRIVATE LIMITED]1
BACITRACINACTIVE MOIETY58H6RWO52IBACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE OINTMENT [GALENTIC PHARMA (INDIA) PRIVATE LIMITED]1
NEOMYCINACTIVE MOIETYI16QD7X297BACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE OINTMENT [GALENTIC PHARMA (INDIA) PRIVATE LIMITED]1
POLYMYXIN BACTIVE MOIETYJ2VZ07J96KBACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE OINTMENT [GALENTIC PHARMA (INDIA) PRIVATE LIMITED]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UBACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE OINTMENT [GALENTIC PHARMA (INDIA) PRIVATE LIMITED]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50382-008BACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE OINTMENT [GALENTIC PHARMA (INDIA) PRIVATE LIMITED]1Legacy NDC, 4 package rows20130808_f562f46c-a764-44f5-b8f4-2d4e97489691.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 OintmentPSNf562f46c-a764-44f5-b8f4-2d4e974896911
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCDf562f46c-a764-44f5-b8f4-2d4e974896911
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSYf562f46c-a764-44f5-b8f4-2d4e974896911

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
50382-008-015038200080128.35 g in 1 TUBE28.35 gHistorical
50382-008-025038200080214.17 g in 1 TUBE14.17 gHistorical
50382-008-035038200080356.7 g in 1 TUBE56.7 gHistorical
50382-008-0450382000804113.4 g in 1 TUBE113.4 gHistorical