FDA.reportPublic FDA data

Clenia Plus

Product NDC
79043-180
Requested package NDC
79043-180-08
11-digit product format
790430180
Labeler code
79043
Product ID
79043-180_1903a7bc-3c3e-4c4a-b0ca-0f8ee5a9a6c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sulfacetamide sodium and sulfur
Dosage form
SUSPENSION
Route
TOPICAL
Labeler
Scite Pharma, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2021-03-10
Marketing end
0000-00-00
Substance
SULFACETAMIDE SODIUM; SULFUR
Active strength
90 mg/mL; mg/mL
Pharmacologic classes
Sulfonamide Antibacterial [EPC],Sulfonamides [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage79043-18079043-180-08DDiscontinued by firm2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage79043-18079043-180-08DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4073022c-5d5d-48f5-82ed-091ad146a4b2Product name120171211
9ffbd0ae-0bce-c086-b707-f0da5f8cd7c5Product name120150828
0304b7d2-7a07-d53b-750f-36012ae6612eProduct name120140508
64c0cc7e-6478-3ca1-8cd7-9a1251d5a3f6Product name120140508
9ae74339-0a3d-82e9-5dd1-88bd2607bd6bProduct name120140508
e44e38a9-2d9e-b0e2-cce9-490554639f3dProduct name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
79043-180-08ML - Milliliter79043-180e552b7a6-e001-47ca-835c-991b8da5b58f12021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79043-180CLENIA PLUS SODIUM SULFACETAMIDE - SULFUR (SULFACETAMIDE SODIUM AND SULFUR) SUSPENSION [SCITE PHARMA, LLC]4Legacy NDC20240712_32bf9d3b-98d5-4cb4-9363-c668e04ec52f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
79043-180-0879043018008237 mL in 1 BOTTLE (79043-180-08) 237 ml2021-03-100000-00-00NoNoCurrent