FDA.reportPublic FDA data

sunmark

Product NDC
49348-274
11-digit product format
493480274
Labeler code
49348
Product ID
49348-274_39e5f2d5-8536-d895-e063-6294a90a5d92
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin zinc and Polymyxin B sulfate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Strategic Sourcing Services LLC
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1990-12-05
Marketing end
2027-09-30
Substance
BACITRACIN ZINC; POLYMYXIN B SULFATE
Active strength
500; 10000 [USP'U]/g; [USP'U]/g
Pharmacologic classes
Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
sunmark
Brand name suffix
double antibiotic

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC500 [USP'U]/g
POLYMYXIN B SULFATE10000 [USP'U]/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii89Y4M234ES, 19371312D4
Rxcui308512

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49348-274-72sunmarkdouble antibiotic28.4 g in 1 TUBEOINTMENT28.45
49348-274-72sunmarkdouble antibiotic1 in 1 CARTONOINTMENT15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-274-72GM - Gram49348-274d7782643-a412-4145-a37e-cab5c515f22512013-02-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Bacitracin zincACTIVE INGREDIENT89Y4M234ESSUNMARK DOUBLE ANTIBIOTIC (BACITRACIN ZINC AND POLYMYXIN B SULFATE) OINTMENT [MCKESSON]1
Polymyxin B sulfateACTIVE INGREDIENT19371312D4SUNMARK DOUBLE ANTIBIOTIC (BACITRACIN ZINC AND POLYMYXIN B SULFATE) OINTMENT [MCKESSON]1
BacitracinACTIVE MOIETY58H6RWO52ISUNMARK DOUBLE ANTIBIOTIC (BACITRACIN ZINC AND POLYMYXIN B SULFATE) OINTMENT [MCKESSON]1
Polymyxin BACTIVE MOIETYJ2VZ07J96KSUNMARK DOUBLE ANTIBIOTIC (BACITRACIN ZINC AND POLYMYXIN B SULFATE) OINTMENT [MCKESSON]1
petrolatumINACTIVE INGREDIENT4T6H12BN9USUNMARK DOUBLE ANTIBIOTIC (BACITRACIN ZINC AND POLYMYXIN B SULFATE) OINTMENT [MCKESSON]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49348-274SUNMARK DOUBLE ANTIBIOTIC (BACITRACIN ZINC AND POLYMYXIN B SULFATE) OINTMENT [STRATEGIC SOURCING SERVICES LLC]4Current NDC, Legacy NDC, 2 package rows20241006_2868de5c-4894-45ee-9647-9acd3bde7cfc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308512bacitracin 500 UNT / polymyxin B 10,000 UNT per GM Topical OintmentPSN2868de5c-4894-45ee-9647-9acd3bde7cfc5
308512bacitracin 500 UNT / polymyxin B 10,000 UNT per GM Topical OintmentPSN3948510f-10b9-454f-9da8-022559d460db5
308512bacitracin 0.5 UNT/MG / polymyxin B 10 UNT/MG Topical OintmentSCD2868de5c-4894-45ee-9647-9acd3bde7cfc5
308512bacitracin 0.5 UNT/MG / polymyxin B 10 UNT/MG Topical OintmentSCD3948510f-10b9-454f-9da8-022559d460db5
308512bacitracin 500 UNT / polymyxin B 10,000 UNT per GM Topical OintmentSY2868de5c-4894-45ee-9647-9acd3bde7cfc5
308512bacitracin 500 UNT / polymyxin B 10,000 UNT per GM Topical OintmentSY3948510f-10b9-454f-9da8-022559d460db5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49348-274-72493480274721 TUBE in 1 CARTON (49348-274-72) / 28.4 g in 1 TUBE1 tube1990-12-052027-09-30NoNoCurrent