Ketoconazole
- Product NDC
- 68788-9903
- 11-digit product format
- 687889903
- Labeler code
- 68788
- Product ID
- 68788-9903_ceeafcbd-3faa-4e32-8283-014f127c7030
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ketoconazole
- Dosage form
- SHAMPOO, SUSPENSION
- Route
- TOPICAL
- Labeler
- Preferred Pharmaceuticals, Inc.
- Application
- ANDA076419
- Marketing category
- ANDA
- Marketing start
- 2012-01-30
- Marketing end
- 0000-00-00
- Substance
- KETOCONAZOLE
- Active strength
- 20 mg/mL
- Pharmacologic classes
- Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-9903-1 | Ketoconazole | 120 mL in 1 BOTTLE, PLASTIC | SHAMPOO, SUSPENSION | 120 | | 11 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| KETOCONAZOLE | ACTIVE INGREDIENT | R9400W927I | KETOCONAZOLE SHAMPOO, SUSPENSION [PREFERRED PHARMACEUTICALS, INC.] | 4 | |
| KETOCONAZOLE | ACTIVE MOIETY | R9400W927I | KETOCONAZOLE SHAMPOO, SUSPENSION [PREFERRED PHARMACEUTICALS, INC.] | 4 | |
| COCO DIETHANOLAMIDE | INACTIVE INGREDIENT | 92005F972D | KETOCONAZOLE SHAMPOO, SUSPENSION [PREFERRED PHARMACEUTICALS, INC.] | 4 | |
| DISODIUM LAURETH SULFOSUCCINATE | INACTIVE INGREDIENT | D6DH1DTN7E | KETOCONAZOLE SHAMPOO, SUSPENSION [PREFERRED PHARMACEUTICALS, INC.] | 4 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | KETOCONAZOLE SHAMPOO, SUSPENSION [PREFERRED PHARMACEUTICALS, INC.] | 4 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | KETOCONAZOLE SHAMPOO, SUSPENSION [PREFERRED PHARMACEUTICALS, INC.] | 4 | |
| IMIDUREA | INACTIVE INGREDIENT | M629807ATL | KETOCONAZOLE SHAMPOO, SUSPENSION [PREFERRED PHARMACEUTICALS, INC.] | 4 | |
| PEG-120 METHYL GLUCOSE DIOLEATE | INACTIVE INGREDIENT | YM0K64F20V | KETOCONAZOLE SHAMPOO, SUSPENSION [PREFERRED PHARMACEUTICALS, INC.] | 4 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | KETOCONAZOLE SHAMPOO, SUSPENSION [PREFERRED PHARMACEUTICALS, INC.] | 4 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | KETOCONAZOLE SHAMPOO, SUSPENSION [PREFERRED PHARMACEUTICALS, INC.] | 4 | |
| SODIUM LAURETH-3 SULFATE | INACTIVE INGREDIENT | BPV390UAP0 | KETOCONAZOLE SHAMPOO, SUSPENSION [PREFERRED PHARMACEUTICALS, INC.] | 4 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | KETOCONAZOLE SHAMPOO, SUSPENSION [PREFERRED PHARMACEUTICALS, INC.] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-9903 | KETOCONAZOLE SHAMPOO, SUSPENSION [PREFERRED PHARMACEUTICALS, INC.] | 11 | Legacy NDC, 1 package rows | 20220713_098afc02-ac71-4214-9fe1-8b519b173bdf.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68788-9903-1 | 68788990301 | 120 mL in 1 BOTTLE, PLASTIC (68788-9903-1) | 120 ml | 2012-01-30 | 0000-00-00 | No | No | Current |