Sulfacetamide Sodium

Product NDC
76420-076
11-digit product format
764200076
Labeler code
76420
Product ID
76420-076_ead2d6e4-62f6-3b3c-e053-2a95a90a4ccd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfacetamide Sodium
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Asclemed USA, Inc.
Application
ANDA089560
Marketing category
ANDA
Marketing start
2003-03-25
Substance
SULFACETAMIDE SODIUM
Active strength
100 mg/mL
Pharmacologic classes
Sulfonamide Antibacterial [EPC], Sulfonamides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sulfacetamide Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFACETAMIDE SODIUM100 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4NRT660KJQ
Rxcui1006120

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76420-076-15Sulfacetamide Sodium15 mL in 1 BOTTLE, PLASTICSOLUTION152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-076SULFACETAMIDE SODIUM SOLUTION [ASCLEMED USA, INC.]2Current NDC, Legacy NDC, 1 package rows20221013_c4c29e13-8303-4a9a-bb47-d7413eaf2f26.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76420-076-157642000761515 mL in 1 BOTTLE, PLASTIC (76420-076-15) 15 ml2020-01-160000-00-00NoNoCurrent