Fluconazole
- Product NDC
- 0143-9667
- 11-digit product format
- 001439667
- Labeler code
- 0143
- Product ID
- 0143-9667_a90257a3-d842-4990-81a5-614293e23119
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluconazole
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA078764
- Marketing category
- ANDA
- Marketing start
- 2012-01-30
- Substance
- FLUCONAZOLE
- Active strength
- 2 mg/mL
- 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 | 2 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8VZV102JFY |
| Rxcui | 1721314, 1721315 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0143-9667-01 | Fluconazole | 100 mL in 1 CONTAINER | INJECTION | 100 | | 19 |
| 0143-9667-06 | Fluconazole | 6 in 1 CARTON | INJECTION | 6 | | 19 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0143-9667 | FLUCONAZOLE INJECTION [HIKMA PHARMACEUTICALS USA INC.] | 19 | Current NDC, Legacy NDC, 2 package rows | 20240629_d3ca59bd-ae00-48ab-89aa-87c7f56e9989.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 |
|---|
| 0143-9667-01 | 00143966701 | 100 mL in 1 CONTAINER | 100 ml | | | | | Historical |
| 0143-9667-06 | 00143966706 | 6 CONTAINER in 1 CARTON (0143-9667-06) / 100 mL in 1 CONTAINER (0143-9667-01) | 6 container | 2012-01-30 | 0000-00-00 | No | No | Current |