FDA.reportPublic FDA data

Bacitracin

Product NDC
0574-4022
11-digit product format
005744022
Labeler code
0574
Product ID
0574-4022_6b07949f-2ca2-4a23-a0a4-a36abd1f565c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bacitracin
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
Padagis US LLC
Application
ANDA061212
Marketing category
ANDA
Marketing start
2014-03-10
Marketing end
0000-00-00
Substance
BACITRACIN
Active strength
500 [USP'U]/g
Pharmacologic classes
Decreased Cell Wall Synthesis & Repair [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0574-4022DDiscontinued by firm2026-07-31
excluded packagepackage0574-40220574-4022-01DDiscontinued by firm2026-07-31
excluded packagepackage0574-40220574-4022-13DDiscontinued by firm2026-07-31
excluded packagepackage0574-40220574-4022-35DDiscontinued by firm2026-07-31

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A061212-001BACITRACINBACITRACIN500 UNITS/GMOINTMENT / OPHTHALMICApproved before 1982

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0574-4022-11GM - Gram0574-40224ba319ca-13c5-4089-926f-7917712e105712014-09-03
0574-4022-13GM - Gram0574-4022537247dc-4a7a-4c79-83e3-c2f3e6a6004012014-09-03
0574-4022-35GM - Gram0574-40228531c58e-456b-4288-9794-b153dd9c512812014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BACITRACINACTIVE INGREDIENT58H6RWO52IBACITRACIN OINTMENT [PADDOCK LABORATORIES, LLC]1
BACITRACINACTIVE MOIETY58H6RWO52IBACITRACIN OINTMENT [PADDOCK LABORATORIES, LLC]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPBACITRACIN OINTMENT [PADDOCK LABORATORIES, LLC]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UBACITRACIN OINTMENT [PADDOCK LABORATORIES, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0574-4022BACITRACIN OINTMENT [PADAGIS US LLC]6Legacy NDC20241102_6ed2f2bd-9d2f-46af-a44c-95a02ca034de.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0574-4022-01005744022011 TUBE in 1 CARTON (0574-4022-01) > 1 g in 1 TUBE (0574-4022-11) 1 tube2014-03-100000-00-00NoNoCurrent
0574-4022-13005744022133 TUBE in 1 CARTON (0574-4022-13) > 1 g in 1 TUBE (0574-4022-11) 3 tube2014-03-100000-00-00NoNoCurrent
0574-4022-35005744022351 TUBE in 1 CARTON (0574-4022-35) > 3.5 g in 1 TUBE1 tube2014-03-100000-00-00NoNoCurrent