Fluconazole
- Product NDC
- 43063-645
- 11-digit product format
- 430630645
- Labeler code
- 43063
- Product ID
- 43063-645_4139d4e5-b633-82bb-e063-6394a90adf79
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluconazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA077731
- Marketing category
- ANDA
- Marketing start
- 2008-10-07
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fluconazole
- Listing expiration
- 2026-12-31
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 |
|---|
| 43063-645-10 | Fluconazole | 10 in 1 BOTTLE, PLASTIC | TABLET | 10 | | 21 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43063-645 | FLUCONAZOLE TABLET [PD-RX PHARMACEUTICALS, INC.] | 20 | Current NDC, Legacy NDC, 1 package rows | 20240925_28d53f27-a0cd-4d8d-e054-00144ff8d46c.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 |
|---|
| 43063-645-10 | 43063064510 | 10 TABLET in 1 BOTTLE, PLASTIC (43063-645-10) | 10 tablet | 2016-01-08 | 0000-00-00 | No | No | Current |