Sulfacetamide Sodium
- Product NDC
- 21695-525
- 11-digit product format
- 216950525
- Labeler code
- 21695
- Product ID
- 21695-525_f43da9e1-1ed7-48e6-b6f4-4794ba0644a1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sulfacetamide Sodium
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- Rebel Distributors Corp
- Application
- ANDA089560
- Marketing category
- ANDA
- Marketing start
- 1988-10-18
- 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 | Effective |
|---|---|---|---|
| 4073022c-5d5d-48f5-82ed-091ad146a4b2 | Product name | 1 | 20171211 |
| 9ffbd0ae-0bce-c086-b707-f0da5f8cd7c5 | Product name | 1 | 20150828 |
| 0304b7d2-7a07-d53b-750f-36012ae6612e | Product name | 1 | 20140508 |
| 64c0cc7e-6478-3ca1-8cd7-9a1251d5a3f6 | Product name | 1 | 20140508 |
| 9ae74339-0a3d-82e9-5dd1-88bd2607bd6b | Product name | 1 | 20140508 |
| e44e38a9-2d9e-b0e2-cce9-490554639f3d | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 21695-525-15 | 2019-09-24 | C162847 | 48780-1 | 934fe258-47e2-48b1-e053-8cdaa90a720a | Sulfacetamide Sodium Ophthalmic Solution USP, 10% |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-525-15 | Sulfacetamide Sodium | 15 mL in 1 BOTTLE, PLASTIC | SOLUTION | 15 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21695-525-15 | ML - Milliliter | 21695-525 | 4af48667-2e57-44e9-ab60-17e110efd7c1 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| sulfacetamide sodium | ACTIVE INGREDIENT | 4NRT660KJQ | SULFACETAMIDE SODIUM SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| sulfacetamide | ACTIVE MOIETY | 4965G3J0F5 | SULFACETAMIDE SODIUM SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| METHYLCELLULOSE (100 CPS) | INACTIVE INGREDIENT | 4GFU244C4J | SULFACETAMIDE SODIUM SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| methylparaben | INACTIVE INGREDIENT | A2I8C7HI9T | SULFACETAMIDE SODIUM SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| propylparaben | INACTIVE INGREDIENT | Z8IX2SC1OH | SULFACETAMIDE SODIUM SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| SODIUM PHOSPHATE, MONOBASIC | INACTIVE INGREDIENT | 3980JIH2SW | SULFACETAMIDE SODIUM SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| sodium thiosulfate | INACTIVE INGREDIENT | HX1032V43M | SULFACETAMIDE SODIUM SOLUTION [REBEL DISTRIBUTORS CORP] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1006120 | sulfacetamide sodium 10 % Ophthalmic Solution | PSN | f43da9e1-1ed7-48e6-b6f4-4794ba0644a1 | 1 |
| 1006120 | sulfacetamide sodium 100 MG/ML Ophthalmic Solution | SCD | f43da9e1-1ed7-48e6-b6f4-4794ba0644a1 | 1 |
| 1006120 | sulfacetamide sodium 10 % Eye Drops | SY | f43da9e1-1ed7-48e6-b6f4-4794ba0644a1 | 1 |
| 1006120 | sulfacetamide sodium 10 % Ophthalmic Solution | SY | f43da9e1-1ed7-48e6-b6f4-4794ba0644a1 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 21695-525-15 | 21695052515 | 15 mL in 1 BOTTLE, PLASTIC | 15 ml | Historical |