Sulfacetamide Sodium and Prednisolone Sodium Phosphate

Product NDC
21695-186
11-digit product format
216950186
Labeler code
21695
Product ID
21695-186_e5a2f3a5-2b9d-4d02-ad5c-e6a890569363
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sulfacetamide sodium and prednisolone sodium phosphate
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Rebel Distributors Corp
Application
ANDA074449
Marketing category
ANDA
Marketing start
1995-12-29
Marketing end
0000-00-00
Substance
SULFACETAMIDE SODIUM; PREDNISOLONE SODIUM PHOSPHATE
Active strength
100 mg/mL; mg/mL
Pharmacologic classes
Sulfonamide Antibacterial [EPC],Sulfonamides [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
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
b3fecff3-fb51-4f66-b443-a130905bb500Product name120250804
3a7a0034-a88d-88c3-f43e-ea34c6a216deProduct name220250311
9dbc4744-f7be-4393-b71a-e1bfd8b97659Product name220250218
9e44d9f9-cb87-3b0f-4c71-c8438d0dc2e5Product name220240102
a0e37fa3-7f16-4fbf-bdb7-ae82cb1a553aProduct name120170309
af7d3306-1338-423f-839e-419aad9e8a86Product name120170309
0304b7d2-7a07-d53b-750f-36012ae6612eProduct name120140508
18d57d04-4a34-a130-5dd5-b7fc47f3b567Product name120140508
379bc253-901a-e6e1-92b7-0fc574249e07Product name120140508
48b05f5d-d2fc-45ab-76e8-3cb5bd44890dProduct name120140508
64c0cc7e-6478-3ca1-8cd7-9a1251d5a3f6Product name120140508
73adedd8-aba8-27d9-78d9-2e3c4a3cf954Product name120140508
9ae74339-0a3d-82e9-5dd1-88bd2607bd6bProduct name120140508
9f10552a-9a7b-8e6c-3223-dc44310af6cfProduct name120140508
e44e38a9-2d9e-b0e2-cce9-490554639f3dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-186-052019-09-24C16284748780-1934fe258-4737-48b1-e053-8cdaa90a720aSulfacetamide Sodium and Prednisolone Sodium Phosphate Ophthalmic Solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-186-05Sulfacetamide Sodium and Prednisolone Sodium Phosphate5 mL in 1 BOTTLESOLUTION51

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-186-05ML - Milliliter21695-186897f448e-94e9-4d03-b4be-02c8e5c8262b12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
prednisolone sodium phosphateACTIVE INGREDIENTIV021NXA9JSULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP]1
sulfacetamide sodiumACTIVE INGREDIENT4NRT660KJQSULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP]1
prednisoloneACTIVE MOIETY9PHQ9Y1OLMSULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP]1
sulfacetamideACTIVE MOIETY4965G3J0F5SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP]1
boric acidINACTIVE INGREDIENTR57ZHV85D4SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP]1
edetate disodiumINACTIVE INGREDIENT7FLD91C86KSULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP]1
hydrochloric acidINACTIVE INGREDIENTQTT17582CBSULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP]1
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP]1
sodium hydroxideINACTIVE INGREDIENT55X04QC32ISULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP]1
thimerosalINACTIVE INGREDIENT2225PI3MOVSULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP]1
waterINACTIVE INGREDIENT059QF0KO0RSULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-186SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20110201_e5a2f3a5-2b9d-4d02-ad5c-e6a890569363.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1012021prednisoLONE sodium phosphate 0.25 % / sulfacetamide sodium 10 % Ophthalmic SolutionPSNe5a2f3a5-2b9d-4d02-ad5c-e6a8905693631
1012021prednisolone sodium phosphate 2.5 MG/ML / sulfacetamide sodium 100 MG/ML Ophthalmic SolutionSCDe5a2f3a5-2b9d-4d02-ad5c-e6a8905693631
1012021prednisolone sodium phosphate 0.25 % / sulfacetamide sodium 10 % Ophthalmic SolutionSYe5a2f3a5-2b9d-4d02-ad5c-e6a8905693631

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
21695-186-05216950186055 mL in 1 BOTTLE5 mlHistorical