Fluconazole
- Product NDC
- 68462-119
- 11-digit product format
- 684620119
- Labeler code
- 68462
- Product ID
- 68462-119_639b832d-b798-4efb-8db0-e64b8ba81574
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluconazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- Application
- ANDA077253
- Marketing category
- ANDA
- Marketing start
- 2020-11-20
- Substance
- FLUCONAZOLE
- Active strength
- 150 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
- 2027-12-31
- 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 | 150 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8VZV102JFY |
| Rxcui | 197698, 197699, 197700, 197701 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68462-119-40 | Fluconazole | 1 in 1 CARTON | TABLET | 1 | | 23 |
| 68462-119-40 | Fluconazole | 1 in 1 BLISTER PACK | TABLET | 1 | | 23 |
| 68462-119-44 | Fluconazole | 1 in 1 BLISTER PACK | TABLET | 1 | | 23 |
| 68462-119-44 | Fluconazole | 12 in 1 CARTON | TABLET | 12 | | 23 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| FLUCONAZOLE | ACTIVE INGREDIENT | 8VZV102JFY | FLUCONAZOLE TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 10 | |
| FLUCONAZOLE | ACTIVE MOIETY | 8VZV102JFY | FLUCONAZOLE TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 10 | |
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS | INACTIVE INGREDIENT | L11K75P92J | FLUCONAZOLE TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 10 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | FLUCONAZOLE TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 10 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | FLUCONAZOLE TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 10 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | FLUCONAZOLE TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 10 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | FLUCONAZOLE TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 10 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68462-119 | FLUCONAZOLE TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 22 | Current NDC, Legacy NDC, 4 package rows | 20240405_3da5f41d-5200-45ac-b89d-00881237ec85.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 |
|---|
| 68462-119-40 | 68462011940 | 1 BLISTER PACK in 1 CARTON (68462-119-40) / 1 TABLET in 1 BLISTER PACK | 1 blister pack | 2020-11-20 | 0000-00-00 | No | No | Current |
| 68462-119-44 | 68462011944 | 12 BLISTER PACK in 1 CARTON (68462-119-44) / 1 TABLET in 1 BLISTER PACK | 12 blister pack | 2020-11-20 | 0000-00-00 | No | No | Current |