ketoconazole
- Product NDC
- 45802-532
- 11-digit product format
- 458020532
- Labeler code
- 45802
- Product ID
- 45802-532_f9768109-216c-49f3-be2a-d0c3eac142b9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ketoconazole
- Dosage form
- AEROSOL, FOAM
- Route
- TOPICAL
- Labeler
- Padagis Israel Pharmaceuticals Ltd
- Application
- ANDA091550
- Marketing category
- ANDA
- Marketing start
- 2011-08-30
- Substance
- KETOCONAZOLE
- Active strength
- 2 g/100g
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ketoconazole
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| KETOCONAZOLE | 2 g/100g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | R9400W927I |
| Rxcui | 728550 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 45802-532-32 | ketoconazole | 1 in 1 CARTON | AEROSOL, FOAM | 1 | | 8 |
| 45802-532-32 | ketoconazole | 50 g in 1 CANISTER | AEROSOL, FOAM | 50 | | 8 |
| 45802-532-33 | ketoconazole | 1 in 1 CARTON | AEROSOL, FOAM | 1 | | 8 |
| 45802-532-33 | ketoconazole | 100 g in 1 CANISTER | AEROSOL, FOAM | 100 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 45802-532 | KETOCONAZOLE AEROSOL, FOAM [PADAGIS ISRAEL PHARMACEUTICALS LTD] | 8 | Current NDC, Legacy NDC, 4 package rows | 20240921_9b65f632-a98d-400e-9ec3-84dea581d6a3.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 |
|---|
| 45802-532-32 | 45802053232 | 1 CANISTER in 1 CARTON (45802-532-32) / 50 g in 1 CANISTER | 1 canister | 2011-08-30 | 0000-00-00 | No | No | Current |
| 45802-532-33 | 45802053233 | 1 CANISTER in 1 CARTON (45802-532-33) / 100 g in 1 CANISTER | 1 canister | 2011-08-30 | 0000-00-00 | No | No | Current |