Fluconazole
- Product NDC
- 0409-3435
- 11-digit product format
- 004093435
- Labeler code
- 0409
- Product ID
- 0409-3435_f49a2c6f-6b6f-43a4-8faf-d21b97ccbbf5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluconazole
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Hospira, Inc
- Application
- ANDA079104
- Marketing category
- ANDA
- Marketing start
- 2025-01-06
- Substance
- FLUCONAZOLE
- Active strength
- 200 mg/100mL
- 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 | 200 mg/100mL |
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 |
|---|
| 0409-3435-01 | Fluconazole | 1 in 1 POUCH | INJECTION, SOLUTION | 1 | | 2 |
| 0409-3435-01 | Fluconazole | 100 mL in 1 BAG | INJECTION, SOLUTION | 100 | | 2 |
| 0409-3435-24 | Fluconazole | 24 in 1 CARTON | INJECTION, SOLUTION | 24 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0409-3435 | FLUCONAZOLE INJECTION, SOLUTION [HOSPIRA, INC] | 2 | Current NDC, 3 package rows | 20250107_22ebc3fb-ee81-44bd-a6e3-5e759ee724a8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0409-3435-01 | 00409343501 | 1 in 1 POUCH | | | | | Historical |
| 0409-3435-24 | 00409343524 | 24 POUCH in 1 CARTON (0409-3435-24) / 1 BAG in 1 POUCH (0409-3435-01) / 100 mL in 1 BAG | 24 pouch | 2025-01-06 | No | No | Current |