Sulfacetamide Sodium

Product NDC
52959-117
11-digit product format
529590117
Labeler code
52959
Product ID
52959-117_629fd51c-0ad7-4ea2-9661-1d654bcbbd17
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfacetamide Sodium
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
H.J. Harkins Company, Inc.
Application
ANDA089560
Marketing category
ANDA
Marketing start
2003-03-25
Marketing end
0000-00-00
Substance
SULFACETAMIDE SODIUM
Active strength
100 mg/mL
Pharmacologic classes
Sulfonamide Antibacterial [EPC],Sulfonamides [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52959-117-012019-11-13C16284748780-197449f38-b54c-f6ea-e053-dbdaa90aa703SULFACETAMIDE SODIUM OPHTHALMIC SOLUTION USP, 10%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-117-01Sulfacetamide Sodium15 mL in 1 BOTTLE, PLASTICSOLUTION154

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-117-01ML - Milliliter52959-11787f9791d-1c59-408f-9151-c62d3f093ec612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFACETAMIDE SODIUMACTIVE INGREDIENT4NRT660KJQSULFACETAMIDE SODIUM SOLUTION [H.J. HARKINS COMPANY, INC.]4
SULFACETAMIDEACTIVE MOIETY4965G3J0F5SULFACETAMIDE SODIUM SOLUTION [H.J. HARKINS COMPANY, INC.]4
METHYLCELLULOSE (4000 CPS)INACTIVE INGREDIENTMRJ667KA5ESULFACETAMIDE SODIUM SOLUTION [H.J. HARKINS COMPANY, INC.]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TSULFACETAMIDE SODIUM SOLUTION [H.J. HARKINS COMPANY, INC.]4
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHSULFACETAMIDE SODIUM SOLUTION [H.J. HARKINS COMPANY, INC.]4
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWSULFACETAMIDE SODIUM SOLUTION [H.J. HARKINS COMPANY, INC.]4
SODIUM THIOSULFATEINACTIVE INGREDIENTHX1032V43MSULFACETAMIDE SODIUM SOLUTION [H.J. HARKINS COMPANY, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-117SULFACETAMIDE SODIUM SOLUTION [H.J. HARKINS COMPANY, INC.]4Legacy NDC, 1 package rows20111118_92f53dc3-cedc-4963-911a-77c3431d4765.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1006120sulfacetamide sodium 10 % Ophthalmic SolutionPSN92f53dc3-cedc-4963-911a-77c3431d47654
1006120sulfacetamide sodium 100 MG/ML Ophthalmic SolutionSCD92f53dc3-cedc-4963-911a-77c3431d47654
1006120sulfacetamide sodium 10 % Eye DropsSY92f53dc3-cedc-4963-911a-77c3431d47654
1006120sulfacetamide sodium 10 % Ophthalmic SolutionSY92f53dc3-cedc-4963-911a-77c3431d47654

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
52959-117-015295901170115 mL in 1 BOTTLE, PLASTIC15 mlHistorical