FDA.reportPublic FDA data

Bacitracin Zinc

Product NDC
51672-2075
11-digit product format
516722075
Labeler code
51672
Product ID
51672-2075_4f1daf7d-bd63-8325-e063-6394a90ac878
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin Zinc
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2006-05-11
Substance
BACITRACIN ZINC
Active strength
500 [USP'U]/g
Pharmacologic classes
Decreased Cell Wall Synthesis & Repair [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Bacitracin Zinc
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii89Y4M234ES
Rxcui1366116

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-2075-1Bacitracin Zinc15 g in 1 TUBEOINTMENT156
51672-2075-1Bacitracin Zinc1 in 1 CARTONOINTMENT16
51672-2075-2Bacitracin Zinc1 in 1 CARTONOINTMENT16
51672-2075-2Bacitracin Zinc30 g in 1 TUBEOINTMENT306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-2075-1GM - Gram51672-2075e945b097-4fbc-49ee-be04-cda62ddd0a1b12013-02-13
51672-2075-2GM - Gram51672-20759d1461f6-ec4f-41a4-abbd-699c44ef8cb812013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Bacitracin ZincACTIVE INGREDIENT89Y4M234ESBACITRACIN ZINC OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
BacitracinACTIVE MOIETY58H6RWO52IBACITRACIN ZINC OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
mineral oilINACTIVE INGREDIENTT5L8T28FGPBACITRACIN ZINC OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
petrolatumINACTIVE INGREDIENT4T6H12BN9UBACITRACIN ZINC OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-2075BACITRACIN ZINC OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]4Current NDC, Legacy NDC, 4 package rows20241105_4afdeedf-9cdf-47d6-919f-ea907fda0290.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1366116bacitracin zinc 500 UNT/GM Topical OintmentPSN9fcda25b-3940-4028-a8ee-6e6c6e4b2a538
1366116bacitracin zinc 0.5 UNT/MG Topical OintmentSCD9fcda25b-3940-4028-a8ee-6e6c6e4b2a538
1366116bacitracin zinc 500 UNT per GM Topical OintmentSY9fcda25b-3940-4028-a8ee-6e6c6e4b2a538
1366116bacitracin zinc 500 UNT/GM Topical OintmentPSN4afdeedf-9cdf-47d6-919f-ea907fda02906
1366116bacitracin zinc 0.5 UNT/MG Topical OintmentSCD4afdeedf-9cdf-47d6-919f-ea907fda02906
1366116bacitracin zinc 500 UNT per GM Topical OintmentSY4afdeedf-9cdf-47d6-919f-ea907fda02906

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-2075-1516722075011 TUBE in 1 CARTON (51672-2075-1) / 15 g in 1 TUBE1 tube2006-05-110000-00-00NoNoCurrent
51672-2075-2516722075021 TUBE in 1 CARTON (51672-2075-2) / 30 g in 1 TUBE1 tube2006-05-110000-00-00NoNoCurrent