Sulfacetamide Sodium

Product NDC
61314-701
11-digit product format
613140701
Labeler code
61314
Product ID
61314-701_6936177e-fec2-4ec0-b81d-af6d0bd43dc6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfacetamide Sodium
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Sandoz 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
No
Listing certified through
2023-12-31
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61314-701-01ML - Milliliter61314-70165ec26b1-74aa-4d77-82d1-dc7cefa90ab612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFACETAMIDE SODIUMACTIVE INGREDIENT4NRT660KJQSULFACETAMIDE SODIUM SOLUTION [KELTMAN PHARMACEUTICALS INC.]4
SULFACETAMIDE SODIUMACTIVE INGREDIENT4NRT660KJQSULFACETAMIDE SODIUM SOLUTION [H.J. HARKINS COMPANY, INC.]4
SULFACETAMIDEACTIVE MOIETY4965G3J0F5SULFACETAMIDE SODIUM SOLUTION [H.J. HARKINS COMPANY, INC.]4
SULFACETAMIDEACTIVE MOIETY4965G3J0F5SULFACETAMIDE SODIUM SOLUTION [KELTMAN PHARMACEUTICALS INC.]4
METHYLCELLULOSE (100 CPS)INACTIVE INGREDIENT4GFU244C4JSULFACETAMIDE SODIUM SOLUTION [KELTMAN PHARMACEUTICALS INC.]4
METHYLCELLULOSE (4000 CPS)INACTIVE INGREDIENTMRJ667KA5ESULFACETAMIDE SODIUM SOLUTION [H.J. HARKINS COMPANY, INC.]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TSULFACETAMIDE SODIUM SOLUTION [KELTMAN PHARMACEUTICALS INC.]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TSULFACETAMIDE SODIUM SOLUTION [H.J. HARKINS COMPANY, INC.]4
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHSULFACETAMIDE SODIUM SOLUTION [KELTMAN PHARMACEUTICALS INC.]4
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHSULFACETAMIDE SODIUM SOLUTION [H.J. HARKINS COMPANY, INC.]4
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWSULFACETAMIDE SODIUM SOLUTION [KELTMAN PHARMACEUTICALS INC.]4
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWSULFACETAMIDE SODIUM SOLUTION [H.J. HARKINS COMPANY, INC.]4
SODIUM THIOSULFATEINACTIVE INGREDIENTHX1032V43MSULFACETAMIDE SODIUM SOLUTION [KELTMAN PHARMACEUTICALS INC.]4
SODIUM THIOSULFATEINACTIVE INGREDIENTHX1032V43MSULFACETAMIDE SODIUM SOLUTION [H.J. HARKINS COMPANY, INC.]4
SULFACETAMIDE SODIUMACTIVE INGREDIENT4NRT660KJQSULFACETAMIDE SODIUM SOLUTION [FALCON PHARMACEUTICALS, LTD.]2
SULFACETAMIDEACTIVE MOIETY4965G3J0F5SULFACETAMIDE SODIUM SOLUTION [FALCON PHARMACEUTICALS, LTD.]2
METHYLCELLULOSE (4000 CPS)INACTIVE INGREDIENTMRJ667KA5ESULFACETAMIDE SODIUM SOLUTION [FALCON PHARMACEUTICALS, LTD.]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TSULFACETAMIDE SODIUM SOLUTION [FALCON PHARMACEUTICALS, LTD.]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHSULFACETAMIDE SODIUM SOLUTION [FALCON PHARMACEUTICALS, LTD.]2
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWSULFACETAMIDE SODIUM SOLUTION [FALCON PHARMACEUTICALS, LTD.]2
SODIUM THIOSULFATEINACTIVE INGREDIENTHX1032V43MSULFACETAMIDE SODIUM SOLUTION [FALCON PHARMACEUTICALS, LTD.]2
sulfacetamide sodiumACTIVE INGREDIENT4NRT660KJQSULFACETAMIDE SODIUM SOLUTION [REBEL DISTRIBUTORS CORP]1
SULFACETAMIDE SODIUMACTIVE INGREDIENT4NRT660KJQSULFACETAMIDE SODIUM SOLUTION/ DROPS [STAT RX USA LLC]1
SULFACETAMIDEACTIVE MOIETY4965G3J0F5SULFACETAMIDE SODIUM SOLUTION/ DROPS [STAT RX USA LLC]1
sulfacetamideACTIVE MOIETY4965G3J0F5SULFACETAMIDE SODIUM SOLUTION [REBEL DISTRIBUTORS CORP]1
METHYLCELLULOSE (100 CPS)INACTIVE INGREDIENT4GFU244C4JSULFACETAMIDE SODIUM SOLUTION [REBEL DISTRIBUTORS CORP]1
METHYLCELLULOSE (100 CPS)INACTIVE INGREDIENT4GFU244C4JSULFACETAMIDE SODIUM SOLUTION/ DROPS [STAT RX USA LLC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TSULFACETAMIDE SODIUM SOLUTION/ DROPS [STAT RX USA LLC]1
methylparabenINACTIVE INGREDIENTA2I8C7HI9TSULFACETAMIDE SODIUM SOLUTION [REBEL DISTRIBUTORS CORP]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHSULFACETAMIDE SODIUM SOLUTION/ DROPS [STAT RX USA LLC]1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHSULFACETAMIDE SODIUM SOLUTION [REBEL DISTRIBUTORS CORP]1
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWSULFACETAMIDE SODIUM SOLUTION [REBEL DISTRIBUTORS CORP]1
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWSULFACETAMIDE SODIUM SOLUTION/ DROPS [STAT RX USA LLC]1
sodium thiosulfateINACTIVE INGREDIENTHX1032V43MSULFACETAMIDE SODIUM SOLUTION [REBEL DISTRIBUTORS CORP]1
SODIUM THIOSULFATEINACTIVE INGREDIENTHX1032V43MSULFACETAMIDE SODIUM SOLUTION/ DROPS [STAT RX USA LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61314-701SULFACETAMIDE SODIUM SOLUTION [SANDOZ INC.]6Legacy NDC20220217_5530fb5f-728b-4a10-a345-01cd749a2684.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1006120sulfacetamide sodium 10 % Ophthalmic SolutionPSN92f53dc3-cedc-4963-911a-77c3431d47654
1006120sulfacetamide sodium 10 % Ophthalmic SolutionPSN1c490337-c060-4f85-9998-f292edea92eb4
1006120sulfacetamide sodium 100 MG/ML Ophthalmic SolutionSCD1c490337-c060-4f85-9998-f292edea92eb4
1006120sulfacetamide sodium 100 MG/ML Ophthalmic SolutionSCD92f53dc3-cedc-4963-911a-77c3431d47654
1006120sulfacetamide sodium 10 % Eye DropsSY92f53dc3-cedc-4963-911a-77c3431d47654
1006120sulfacetamide sodium 10 % Eye DropsSY1c490337-c060-4f85-9998-f292edea92eb4
1006120sulfacetamide sodium 10 % Ophthalmic SolutionSY1c490337-c060-4f85-9998-f292edea92eb4
1006120sulfacetamide sodium 10 % Ophthalmic SolutionSY92f53dc3-cedc-4963-911a-77c3431d47654
1006120sulfacetamide sodium 10 % Ophthalmic SolutionPSNc4c29e13-8303-4a9a-bb47-d7413eaf2f262
1006120sulfacetamide sodium 100 MG/ML Ophthalmic SolutionSCDc4c29e13-8303-4a9a-bb47-d7413eaf2f262
1006120sulfacetamide sodium 10 % Eye DropsSYc4c29e13-8303-4a9a-bb47-d7413eaf2f262
1006120sulfacetamide sodium 10 % Ophthalmic SolutionSYc4c29e13-8303-4a9a-bb47-d7413eaf2f262
1006120sulfacetamide sodium 10 % Ophthalmic SolutionPSN9294ddc5-3778-40af-9d6c-1bea2e1452201
1006120sulfacetamide sodium 10 % Ophthalmic SolutionPSNf43da9e1-1ed7-48e6-b6f4-4794ba0644a11
1006120sulfacetamide sodium 10 % Ophthalmic SolutionPSN1bc451c8-4d7c-a8a4-e063-6394a90a91df1
1006120sulfacetamide sodium 100 MG/ML Ophthalmic SolutionSCD1bc451c8-4d7c-a8a4-e063-6394a90a91df1
1006120sulfacetamide sodium 100 MG/ML Ophthalmic SolutionSCDf43da9e1-1ed7-48e6-b6f4-4794ba0644a11
1006120sulfacetamide sodium 100 MG/ML Ophthalmic SolutionSCD9294ddc5-3778-40af-9d6c-1bea2e1452201
1006120sulfacetamide sodium 10 % Eye DropsSY9294ddc5-3778-40af-9d6c-1bea2e1452201
1006120sulfacetamide sodium 10 % Eye DropsSYf43da9e1-1ed7-48e6-b6f4-4794ba0644a11
1006120sulfacetamide sodium 10 % Eye DropsSY1bc451c8-4d7c-a8a4-e063-6394a90a91df1
1006120sulfacetamide sodium 10 % Ophthalmic SolutionSY9294ddc5-3778-40af-9d6c-1bea2e1452201
1006120sulfacetamide sodium 10 % Ophthalmic SolutionSY1bc451c8-4d7c-a8a4-e063-6394a90a91df1
1006120sulfacetamide sodium 10 % Ophthalmic SolutionSYf43da9e1-1ed7-48e6-b6f4-4794ba0644a11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61314-701-016131407010115 mL in 1 BOTTLE, PLASTIC (61314-701-01) 15 ml2003-03-250000-00-00NoNoCurrent