OVACE

Product NDC
0178-0499
Requested package NDC
0178-0499-06
11-digit product format
001780499
Labeler code
0178
Product ID
0178-0499_47e771ab-b852-724f-e063-6394a90ac63c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SULFACETAMIDE SODIUM
Dosage form
LIQUID
Route
TOPICAL
Labeler
Mission Pharmacal Company
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2011-09-15
Substance
SULFACETAMIDE SODIUM
Active strength
100 mg/mL
Pharmacologic classes
Sulfonamide Antibacterial [EPC], Sulfonamides [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFACETAMIDE SODIUM100 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4NRT660KJQInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1006107Internal RxNorm lookup
1006110Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a77aed6c-355f-44ed-ae95-78b4d1549c2bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0178-0499-06OVACE180 mL in 1 BOTTLE, PLASTICLIQUID18010
0178-0499-12OVACE355 mL in 1 BOTTLE, PLASTICLIQUID35510
0178-0499-16OVACE480 mL in 1 BOTTLE, PLASTICLIQUID48010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0178-0499-06ML - Milliliter0178-0499671cfa0f-fed4-4410-8634-011457fef0b812013-07-02
0178-0499-12ML - Milliliter0178-049937ef293f-d09d-488c-a90f-2c9d0bda5fa212013-02-13
0178-0499-16ML - Milliliter0178-0499a7863d99-5da7-40e9-bd48-dd8048df2aa712014-02-04

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0178-0499OVACE (SULFACETAMIDE SODIUM) LIQUID [MISSION PHARMACAL COMPANY]9Current NDC, Legacy NDC, 3 package rows20230908_a77aed6c-355f-44ed-ae95-78b4d1549c2b.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OVACESULFACETAMIDE SODIUMMission Pharmacal Companya77aed6c-355f-44ed-ae95-78b4d1549c2b2026-01-08Warnings, Adverse reactionsExact identifier
ndc (package): 0178-0499-06
ndc (product): 0178-0499
ndc11 (package): 00178049906

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1006110OVACE 10 % Medicated Liquid SoapPSNa77aed6c-355f-44ed-ae95-78b4d1549c2b10
1006107sulfacetamide sodium 10 % Medicated Liquid SoapPSNa77aed6c-355f-44ed-ae95-78b4d1549c2b10
1006110sulfacetamide sodium 100 MG/ML Medicated Liquid Soap [Ovace]SBDa77aed6c-355f-44ed-ae95-78b4d1549c2b10
1006107sulfacetamide sodium 100 MG/ML Medicated Liquid SoapSCDa77aed6c-355f-44ed-ae95-78b4d1549c2b10
1006110Ovace 10 % Medicated Liquid SoapSYa77aed6c-355f-44ed-ae95-78b4d1549c2b10
1006110Ovace 100 MG/ML Medicated Liquid SoapSYa77aed6c-355f-44ed-ae95-78b4d1549c2b10
1006110Ovace Plus 10 % Topical WashSYa77aed6c-355f-44ed-ae95-78b4d1549c2b10
1006107sulfacetamide sodium 10 % Medicated Liquid SoapSYa77aed6c-355f-44ed-ae95-78b4d1549c2b10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0178-0499-0600178049906180 mL in 1 BOTTLE, PLASTIC (0178-0499-06) 180 ml2011-09-150000-00-00NoNoCurrent