FDA.reportPublic FDA data

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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct69784-880DDiscontinued by firm2026-07-31
excluded packagepackage69784-88069784-880-01DDiscontinued by firm2026-07-31
excluded packagepackage69784-88069784-880-35DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

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

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A061212-001BACITRACIN500 UNITS/GMOINTMENT / OPHTHALMICApproved before 1982a50c72e98297…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69784-880-012025-09-18C16284748780-1d6a99b39-464c-a426-e053-dadaa90af4c2BACIGUENT (bacitracin) Ophthalmic Ointment USP
69784-880-352025-09-18C16284748780-1d6a99b39-464c-a426-e053-dadaa90af4c2BACIGUENT (bacitracin) Ophthalmic Ointment USP
69784-880-012022-01-28C16284748780-1d6a99b39-464c-a426-e053-dadaa90af4c2BACIGUENT (bacitracin) Ophthalmic Ointment USP
69784-880-352022-01-28C16284748780-1d6a99b39-464c-a426-e053-dadaa90af4c2BACIGUENT (bacitracin) Ophthalmic Ointment USP

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