fluconazole
- Product NDC
- 50090-4425
- 11-digit product format
- 500904425
- Labeler code
- 50090
- Product ID
- 50090-4425_db5ecbc8-7329-45c5-b19a-d0e79fbe1659
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fluconazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA208963
- Marketing category
- ANDA
- Marketing start
- 2017-04-06
- 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 | 197699 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 50090-4425-0 | 2023-02-07 | C162847 | 48780-1 | f386c649-e293-0266-e053-dadaa90a7c1a | Fluconazole Tablets, USP Rx only |
| 50090-4425-1 | 2023-02-07 | C162847 | 48780-1 | f386c649-e293-0266-e053-dadaa90a7c1a | Fluconazole Tablets, USP Rx only |
| 50090-4425-2 | 2023-02-07 | C162847 | 48780-1 | f386c649-e293-0266-e053-dadaa90a7c1a | Fluconazole Tablets, USP Rx only |
| 50090-4425-3 | 2023-02-07 | C162847 | 48780-1 | f386c649-e293-0266-e053-dadaa90a7c1a | Fluconazole Tablets, USP Rx only |
| 50090-4425-0 | 2023-01-30 | C162847 | 48780-1 | f386c649-e293-0266-e053-dadaa90a7c1a | Fluconazole Tablets, USP Rx only |
| 50090-4425-1 | 2023-01-30 | C162847 | 48780-1 | f386c649-e293-0266-e053-dadaa90a7c1a | Fluconazole Tablets, USP Rx only |
| 50090-4425-2 | 2023-01-30 | C162847 | 48780-1 | f386c649-e293-0266-e053-dadaa90a7c1a | Fluconazole Tablets, USP Rx only |
| 50090-4425-3 | 2023-01-30 | C162847 | 48780-1 | f386c649-e293-0266-e053-dadaa90a7c1a | Fluconazole Tablets, USP Rx only |
DailyMed Package Descriptions#
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 |
|---|
| 50090-4425-0 | 50090442500 | 1 BLISTER PACK in 1 CARTON (50090-4425-0) / 1 TABLET in 1 BLISTER PACK | 1 blister pack | 2019-07-19 | 0000-00-00 | No | No | Current |
| 50090-4425-1 | 50090442501 | 12 BLISTER PACK in 1 CARTON (50090-4425-1) / 1 TABLET in 1 BLISTER PACK | 12 blister pack | 2019-07-19 | 0000-00-00 | No | No | Current |
| 50090-4425-2 | 50090442502 | 2 BLISTER PACK in 1 CARTON (50090-4425-2) / 1 TABLET in 1 BLISTER PACK | 2 blister pack | 2019-07-19 | 0000-00-00 | No | No | Current |
| 50090-4425-3 | 50090442503 | 4 BLISTER PACK in 1 CARTON (50090-4425-3) / 1 TABLET in 1 BLISTER PACK | 4 blister pack | 2019-07-19 | 0000-00-00 | No | No | Current |