FDA.reportPublic FDA data

BACITRACIN ZINC

Product NDC
58980-011
11-digit product format
589800011
Labeler code
58980
Product ID
58980-011_989398c9-b804-46c7-b8bf-20d9dabcb245
Type
HUMAN OTC DRUG
Nonproprietary name
BACITRACIN ZINC
Dosage form
OINTMENT
Route
TOPICAL
Labeler
STRATUS PHARMACEUTICALS INC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-09-15
Substance
BACITRACIN ZINC
Active strength
500 [USP'U]/g
Pharmacologic classes
Decreased Cell Wall Synthesis & Repair [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
BACITRACIN ZINC
Listing expiration
2026-12-31

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
58980-011-01BACITRACIN ZINC144 in 1 BOXOINTMENT1443
58980-011-01BACITRACIN ZINC1 g in 1 PACKETOINTMENT13
58980-011-10BACITRACIN ZINC1 in 1 BOXOINTMENT13
58980-011-10BACITRACIN ZINC28.35 g in 1 TUBEOINTMENT28.353

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58980-011-01GM - Gram58980-011ed1efaa5-281e-49da-b478-d773777e69a512020-06-05
58980-011-10GM - Gram58980-011435dc26d-b088-408a-aa6e-5d766734c9db12018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58980-011BACITRACIN ZINC OINTMENT [STRATUS PHARMACEUTICALS INC]3Current NDC, Legacy NDC, 4 package rows20241105_b2cb3a96-b0ca-42ee-8056-91d5450fb376.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1366116bacitracin zinc 500 UNT/GM Topical OintmentPSNb2cb3a96-b0ca-42ee-8056-91d5450fb3763
1366116bacitracin zinc 0.5 UNT/MG Topical OintmentSCDb2cb3a96-b0ca-42ee-8056-91d5450fb3763
1366116bacitracin zinc 500 UNT per GM Topical OintmentSYb2cb3a96-b0ca-42ee-8056-91d5450fb3763

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58980-011-0158980001101144 PACKET in 1 BOX (58980-011-01) / 1 g in 1 PACKET144 packet2020-05-150000-00-00NoNoCurrent
58980-011-10589800011101 TUBE in 1 BOX (58980-011-10) / 28.35 g in 1 TUBE1 tube2017-09-150000-00-00NoNoCurrent