Fluconazole
- Product NDC
- 10544-855
- 11-digit product format
- 105440855
- Labeler code
- 10544
- Product ID
- 10544-855_1467b4ed-05ef-6147-e054-00144ff8d46c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluconazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Blenheim Pharmacal, Inc.
- Application
- ANDA077253
- Marketing category
- ANDA
- Marketing start
- 2015-04-22
- Marketing end
- 0000-00-00
- Substance
- FLUCONAZOLE
- Active strength
- 150 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
- E
- Listing certified through
- 2017-12-31
- 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 |
|---|
| 10544-855-91 | Fluconazole | 1 in 1 BLISTER PACK | TABLET | 1 | | 1 |
| 10544-855-91 | Fluconazole | 1 in 1 CARTON | TABLET | 1 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| FLUCONAZOLE | ACTIVE INGREDIENT | 8VZV102JFY | FLUCONAZOLE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| FLUCONAZOLE | ACTIVE MOIETY | 8VZV102JFY | FLUCONAZOLE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS | INACTIVE INGREDIENT | L11K75P92J | FLUCONAZOLE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | FLUCONAZOLE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | FLUCONAZOLE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | FLUCONAZOLE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | FLUCONAZOLE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10544-855 | FLUCONAZOLE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | Legacy NDC, 2 package rows | 20150423_1467b4ed-05ee-6147-e054-00144ff8d46c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 10544-855-91 | 10544085591 | 1 in 1 BLISTER PACK | Historical |