SULFACETAMIDE SODIUM
- Product NDC
- 68387-491
- 11-digit product format
- 683870491
- Labeler code
- 68387
- Product ID
- 68387-491_b3fe37b1-8adc-4728-a7c7-9fec050b21ec
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SULFACETAMIDE SODIUM
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- Keltman Pharmaceuticals Inc.
- Application
- ANDA089560
- Marketing category
- ANDA
- Marketing start
- 2010-01-10
- 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 |
|---|---|---|---|---|---|
| 68387-491-01 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-cfa4-8e05-e053-dbdaa90a074a | SULFACETAMIDE SODIUM - sulfacetamide sodium solution |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68387-491-01 | SULFACETAMIDE SODIUM | 15 mL in 1 BOTTLE | SOLUTION | 15 | 4 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68387-491-01 | ML - Milliliter | 68387-491 | f09b07e6-f977-4315-84b2-85278c800b39 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| SULFACETAMIDE SODIUM | ACTIVE INGREDIENT | 4NRT660KJQ | SULFACETAMIDE SODIUM SOLUTION [KELTMAN PHARMACEUTICALS INC.] | 4 | |
| SULFACETAMIDE | ACTIVE MOIETY | 4965G3J0F5 | SULFACETAMIDE SODIUM SOLUTION [KELTMAN PHARMACEUTICALS INC.] | 4 | |
| METHYLCELLULOSE (100 CPS) | INACTIVE INGREDIENT | 4GFU244C4J | SULFACETAMIDE SODIUM SOLUTION [KELTMAN PHARMACEUTICALS INC.] | 4 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | SULFACETAMIDE SODIUM SOLUTION [KELTMAN PHARMACEUTICALS INC.] | 4 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | SULFACETAMIDE SODIUM SOLUTION [KELTMAN PHARMACEUTICALS INC.] | 4 | |
| SODIUM PHOSPHATE, MONOBASIC | INACTIVE INGREDIENT | 3980JIH2SW | SULFACETAMIDE SODIUM SOLUTION [KELTMAN PHARMACEUTICALS INC.] | 4 | |
| SODIUM THIOSULFATE | INACTIVE INGREDIENT | HX1032V43M | SULFACETAMIDE SODIUM SOLUTION [KELTMAN PHARMACEUTICALS INC.] | 4 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1006120 | sulfacetamide sodium 10 % Ophthalmic Solution | PSN | 1c490337-c060-4f85-9998-f292edea92eb | 4 |
| 1006120 | sulfacetamide sodium 100 MG/ML Ophthalmic Solution | SCD | 1c490337-c060-4f85-9998-f292edea92eb | 4 |
| 1006120 | sulfacetamide sodium 10 % Eye Drops | SY | 1c490337-c060-4f85-9998-f292edea92eb | 4 |
| 1006120 | sulfacetamide sodium 10 % Ophthalmic Solution | SY | 1c490337-c060-4f85-9998-f292edea92eb | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 68387-491-01 | 68387049101 | 15 mL in 1 BOTTLE | 15 ml | Historical |