FDA.reportPublic FDA data

SULFACETAMIDE SODIUM

Product NDC
61919-209
11-digit product format
619190209
Labeler code
61919
Product ID
61919-209_9cad1a67-25de-4da8-e053-2a95a90a6abd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SULFACETAMIDE SODIUM
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
DIRECT RX
Application
ANDA040066
Marketing category
ANDA
Marketing start
2014-01-01
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
2021-12-31
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
61919-209-152023-01-30C16284748780-1f386c64a-0a1f-0266-e053-dadaa90a7c1aSULFACETAMIDE SODIUM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-209-15SULFACETAMIDE SODIUM15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS153

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-209-15ML - Milliliter61919-2092d4994e6-7ab5-4716-9d4d-015e0ee54a9c12015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFACETAMIDE SODIUMACTIVE INGREDIENT4NRT660KJQSULFACETAMIDE SODIUM SOLUTION/ DROPS [DIRECT RX]1
SULFACETAMIDEACTIVE MOIETY4965G3J0F5SULFACETAMIDE SODIUM SOLUTION/ DROPS [DIRECT RX]1
METHYLCELLULOSE (100 CPS)INACTIVE INGREDIENT4GFU244C4JSULFACETAMIDE SODIUM SOLUTION/ DROPS [DIRECT RX]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TSULFACETAMIDE SODIUM SOLUTION/ DROPS [DIRECT RX]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHSULFACETAMIDE SODIUM SOLUTION/ DROPS [DIRECT RX]1
SODIUM THIOSULFATEINACTIVE INGREDIENTHX1032V43MSULFACETAMIDE SODIUM SOLUTION/ DROPS [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-209SULFACETAMIDE SODIUM SOLUTION/ DROPS [DIRECT RX]3Legacy NDC, 1 package rows20200122_fae0c19a-2177-4aa7-9266-320b8502065e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1006120sulfacetamide sodium 10 % Ophthalmic SolutionPSNfae0c19a-2177-4aa7-9266-320b8502065e3
1006120sulfacetamide sodium 100 MG/ML Ophthalmic SolutionSCDfae0c19a-2177-4aa7-9266-320b8502065e3
1006120sulfacetamide sodium 10 % Eye DropsSYfae0c19a-2177-4aa7-9266-320b8502065e3
1006120sulfacetamide sodium 10 % Ophthalmic SolutionSYfae0c19a-2177-4aa7-9266-320b8502065e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-209-156191902091515 mL in 1 BOTTLE, DROPPER (61919-209-15) 15 ml2015-01-010000-00-00NoNoCurrent