Fluconazole
- Product NDC
- 53002-4400
- 11-digit product format
- 530024400
- Labeler code
- 53002
- Product ID
- 53002-4400_c1e1a93a-ff95-44c5-bf21-d5c16b6bd90f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluconazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA078423
- Marketing category
- ANDA
- Marketing start
- 2011-03-07
- Marketing end
- 0000-00-00
- Substance
- FLUCONAZOLE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Azole Antifungal [EPC],Azoles [CS],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- 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 |
|---|
| 53002-4400-1 | Fluconazole | 3 in 1 BOTTLE | TABLET | 3 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-4400 | FLUCONAZOLE TABLET [RPK PHARMACEUTICALS, INC.] | 5 | Legacy NDC, 1 package rows | 20210617_b00ead0c-c3fc-43a0-bc85-86c6c155635e.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 |
|---|
| 53002-4400-1 | 53002440001 | 3 TABLET in 1 BOTTLE (53002-4400-1) | 3 tablet | 2018-10-01 | 0000-00-00 | No | No | Current |