BACIGUENT

Product NDC
69784-880
11-digit product format
697840880
Labeler code
69784
Product ID
69784-880_e9a41f2f-5955-451c-8d9f-7a2594da99ea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bacitracin
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
Woodward Pharma Services LLC
Application
ANDA061212
Marketing category
ANDA
Marketing start
2020-04-15
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
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69784-880-35GM - Gram69784-880f1741427-feac-4c1f-84c0-6aa89baa0d3a12020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69784-880BACIGUENT (BACITRACIN) OINTMENT [WOODWARD PHARMA SERVICES LLC]2Legacy NDC20200827_d0155eb8-3d05-4e02-9b05-584ee629e7a7.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69784-880-01697840880013 TUBE in 1 CARTON (69784-880-01) > 1 g in 1 TUBE3 tube2020-04-150000-00-00NoNoCurrent
69784-880-35697840880351 TUBE in 1 CARTON (69784-880-35) > 3.5 g in 1 TUBE1 tube2020-04-150000-00-00NoNoCurrent