FDA.reportPublic FDA data

Double Antibiotic

Product NDC
58980-012
11-digit product format
589800012
Labeler code
58980
Product ID
58980-012_6c82f396-e1f6-4210-87b1-2615eedbdc6a
Type
HUMAN OTC DRUG
Nonproprietary name
BACITRACIN ZINC and POLYMYXIN B SULFATE
Dosage form
OINTMENT
Route
TOPICAL
Labeler
STRATUS PHARMACEUTICALS INC
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-09-15
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
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Double Antibiotic
Listing expiration
2027-12-31

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
58980-012-01Double Antibiotic144 in 1 BOXOINTMENT1444
58980-012-01Double Antibiotic0.9 g in 1 PACKETOINTMENT0.94
58980-012-05Double Antibiotic14.2 g in 1 TUBEOINTMENT14.24
58980-012-05Double Antibiotic1 in 1 BOXOINTMENT14
58980-012-10Double Antibiotic28.35 g in 1 TUBEOINTMENT28.354
58980-012-10Double Antibiotic1 in 1 BOXOINTMENT14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58980-012-01EA - Each58980-01274ba8db2-0c1b-4268-906c-c36d78ae6d6412020-02-13
58980-012-05GM - Gram58980-012cd555393-3a0f-4bb3-9a1b-3a1c2a476b7312021-03-02
58980-012-10GM - Gram58980-012229bf842-dc27-4c41-8c20-c431dc24b98612026-03-17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58980-012BACITRACIN ZINC (BACITRACIN ZINC AND POLYMYXIN B SULFATE) OINTMENT [STRATUS PHARMACEUTICALS INC]3Current NDC, Legacy NDC, 6 package rows20241107_f64b3564-ea3c-4316-8f00-f92c08dcad35.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308512bacitracin 500 UNT / polymyxin B 10,000 UNT per GM Topical OintmentPSNf64b3564-ea3c-4316-8f00-f92c08dcad354
308512bacitracin 0.5 UNT/MG / polymyxin B 10 UNT/MG Topical OintmentSCDf64b3564-ea3c-4316-8f00-f92c08dcad354
308512bacitracin 500 UNT / polymyxin B 10,000 UNT per GM Topical OintmentSYf64b3564-ea3c-4316-8f00-f92c08dcad354

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58980-012-0158980001201144 PACKET in 1 BOX (58980-012-01) / .9 g in 1 PACKET144 packet2017-09-150000-00-00NoNoCurrent
58980-012-05589800012051 TUBE in 1 BOX (58980-012-05) / 14.2 g in 1 TUBE1 tube2021-02-080000-00-00NoNoCurrent
58980-012-10589800012101 TUBE in 1 BOX (58980-012-10) / 28.35 g in 1 TUBE1 tube2026-01-26NoNoCurrent