Fluconazole
- Product NDC
- 55289-824
- 11-digit product format
- 552890824
- Labeler code
- 55289
- Product ID
- 55289-824_2ac0449d-f1fd-33f4-e063-6394a90a9402
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluconazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA077253
- Marketing category
- ANDA
- Marketing start
- 2006-01-25
- Substance
- FLUCONAZOLE
- Active strength
- 200 mg/1
- Pharmacologic classes
- Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 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
- Fluconazole
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FLUCONAZOLE | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8VZV102JFY |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55289-824-20 | Fluconazole | 20 in 1 BOTTLE, PLASTIC | TABLET | 20 | | 31 |
| 55289-824-30 | Fluconazole | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 31 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| FLUCONAZOLE | ACTIVE INGREDIENT | 8VZV102JFY | FLUCONAZOLE TABLET [PD-RX PHARMACEUTICALS, INC.] | 5 | |
| FLUCONAZOLE | ACTIVE MOIETY | 8VZV102JFY | FLUCONAZOLE TABLET [PD-RX PHARMACEUTICALS, INC.] | 5 | |
| ANHYDROUS DIBASIC CALCIUM PHOSPHATE | INACTIVE INGREDIENT | L11K75P92J | FLUCONAZOLE TABLET [PD-RX PHARMACEUTICALS, INC.] | 5 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | FLUCONAZOLE TABLET [PD-RX PHARMACEUTICALS, INC.] | 5 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | FLUCONAZOLE TABLET [PD-RX PHARMACEUTICALS, INC.] | 5 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | FLUCONAZOLE TABLET [PD-RX PHARMACEUTICALS, INC.] | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | FLUCONAZOLE TABLET [PD-RX PHARMACEUTICALS, INC.] | 5 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | FLUCONAZOLE TABLET [PD-RX PHARMACEUTICALS, INC.] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55289-824 | FLUCONAZOLE TABLET [PD-RX PHARMACEUTICALS, INC.] | 31 | Current NDC, Legacy NDC, 2 package rows | 20250104_dd975843-c3e4-44f4-bb0d-33b294c1f6fb.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 |
|---|
| 55289-824-20 | 55289082420 | 20 TABLET in 1 BOTTLE, PLASTIC (55289-824-20) | 20 tablet | 2011-05-20 | 0000-00-00 | No | No | Current |
| 55289-824-30 | 55289082430 | 30 TABLET in 1 BOTTLE, PLASTIC (55289-824-30) | 30 tablet | 2011-05-20 | 0000-00-00 | No | No | Current |