fluconazole
- Product NDC
- 70518-2415
- 11-digit product format
- 705182415
- Labeler code
- 70518
- Product ID
- 70518-2415_4f94ff0a-6184-d778-e063-6394a90a9de9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fluconazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA208963
- Marketing category
- ANDA
- Marketing start
- 2019-11-11
- Substance
- FLUCONAZOLE
- Active strength
- 100 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 | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8VZV102JFY |
| Rxcui | 197698 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-2415-0 | fluconazole | 30 in 1 BLISTER PACK | TABLET | 30 | | 15 |
| 70518-2415-1 | fluconazole | 16 in 1 BOTTLE, PLASTIC | TABLET | 16 | | 15 |
| 70518-2415-2 | fluconazole | 8 in 1 BOTTLE, PLASTIC | TABLET | 8 | | 15 |
| 70518-2415-3 | fluconazole | 30 in 1 BOX | TABLET | 30 | | 15 |
| 70518-2415-4 | fluconazole | 1 in 1 POUCH | TABLET | 1 | | 15 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-2415 | FLUCONAZOLE TABLET [REMEDYREPACK INC.] | 10 | Current NDC, Legacy NDC, 5 package rows | 20250315_b5cfe0a1-f55c-41b1-8ad6-d1d0134a4d1d.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 |
|---|
| 70518-2415-0 | 70518241500 | 30 TABLET in 1 BLISTER PACK (70518-2415-0) | 30 tablet | 2019-11-11 | 0000-00-00 | No | No | Current |
| 70518-2415-1 | 70518241501 | 16 TABLET in 1 BOTTLE, PLASTIC (70518-2415-1) | 16 tablet | 2024-08-23 | | No | No | Historical |
| 70518-2415-2 | 70518241502 | 8 TABLET in 1 BOTTLE, PLASTIC (70518-2415-2) | 8 tablet | 2024-08-23 | | No | No | Historical |
| 70518-2415-3 | 70518241503 | 30 in 1 BOX | | | | | | Historical |
| 70518-2415-4 | 70518241504 | 1 in 1 POUCH | | | | | | Historical |