Fluconazole
- Product NDC
- 50090-2195
- 11-digit product format
- 500902195
- Labeler code
- 50090
- Product ID
- 50090-2195_0eaa42bc-0006-47e5-a302-1c369883f0fc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluconazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA077731
- Marketing category
- ANDA
- Marketing start
- 2008-10-07
- 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
- 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 |
|---|---|
| FLUCONAZOLE | 150 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 8VZV102JFY |
| Rxcui | 197699 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 74f0b828-cb79-42cb-bb6c-81c9f5bd2648 | Product name | 2 | 20250623 |
| fe6bb120-ebc6-6290-9eab-e842fdb6c841 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50090-2195-0 | 2023-02-07 | C162847 | 48780-1 | f386c649-e4ff-0266-e053-dadaa90a7c1a | Fluconazole Tablets USP Rx only |
| 50090-2195-1 | 2023-02-07 | C162847 | 48780-1 | f386c649-e4ff-0266-e053-dadaa90a7c1a | Fluconazole Tablets USP Rx only |
| 50090-2195-2 | 2023-02-07 | C162847 | 48780-1 | f386c649-e4ff-0266-e053-dadaa90a7c1a | Fluconazole Tablets USP Rx only |
| 50090-2195-3 | 2023-02-07 | C162847 | 48780-1 | f386c649-e4ff-0266-e053-dadaa90a7c1a | Fluconazole Tablets USP Rx only |
| 50090-2195-0 | 2023-01-30 | C162847 | 48780-1 | f386c649-e4ff-0266-e053-dadaa90a7c1a | Fluconazole Tablets USP Rx only |
| 50090-2195-1 | 2023-01-30 | C162847 | 48780-1 | f386c649-e4ff-0266-e053-dadaa90a7c1a | Fluconazole Tablets USP Rx only |
| 50090-2195-2 | 2023-01-30 | C162847 | 48780-1 | f386c649-e4ff-0266-e053-dadaa90a7c1a | Fluconazole Tablets USP Rx only |
| 50090-2195-3 | 2023-01-30 | C162847 | 48780-1 | f386c649-e4ff-0266-e053-dadaa90a7c1a | Fluconazole Tablets USP Rx only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-2195-0 | Fluconazole | 1 in 1 BLISTER PACK | TABLET | 1 | 12 | |
| 50090-2195-0 | Fluconazole | 1 in 1 CARTON | TABLET | 1 | 12 | |
| 50090-2195-1 | Fluconazole | 1 in 1 CARTON | TABLET | 1 | 12 | |
| 50090-2195-1 | Fluconazole | 12 in 1 BLISTER PACK | TABLET | 12 | 12 | |
| 50090-2195-2 | Fluconazole | 2 in 1 BLISTER PACK | TABLET | 2 | 12 | |
| 50090-2195-2 | Fluconazole | 1 in 1 CARTON | TABLET | 1 | 12 | |
| 50090-2195-3 | Fluconazole | 1 in 1 CARTON | TABLET | 1 | 12 | |
| 50090-2195-3 | Fluconazole | 4 in 1 BLISTER PACK | TABLET | 4 | 12 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-2195-0 | EA - Each | 50090-2195 | d310e622-7915-441c-afd6-8b2358911674 | 1 | 2021-08-05 |
| 50090-2195-1 | EA - Each | 50090-2195 | 9551a7b3-60cf-4cb1-a2e4-3f3e18552f6a | 1 | 2024-12-10 |
| 50090-2195-2 | EA - Each | 50090-2195 | 0f9726ae-5743-4fa1-8b4d-16cb6c5788b7 | 1 | 2021-09-07 |
| 50090-2195-3 | EA - Each | 50090-2195 | 8126d907-080d-433e-ba1d-952bd1695343 | 1 | 2024-12-10 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-2195 | FLUCONAZOLE TABLET [A-S MEDICATION SOLUTIONS] | 12 | Current NDC, Legacy NDC, 8 package rows | 20241120_177322f4-9526-40cb-9e5d-bc24e8fb02db.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197699 | fluconazole 150 MG Oral Tablet | PSN | 177322f4-9526-40cb-9e5d-bc24e8fb02db | 12 |
| 197699 | fluconazole 150 MG Oral Tablet | SCD | 177322f4-9526-40cb-9e5d-bc24e8fb02db | 12 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50090-2195-0 | 50090219500 | 1 BLISTER PACK in 1 CARTON (50090-2195-0) / 1 TABLET in 1 BLISTER PACK | 1 blister pack | 2015-10-27 | 0000-00-00 | No | No | Current |
| 50090-2195-1 | 50090219501 | 1 BLISTER PACK in 1 CARTON (50090-2195-1) / 12 TABLET in 1 BLISTER PACK | 1 blister pack | 2015-10-27 | 0000-00-00 | No | No | Current |
| 50090-2195-2 | 50090219502 | 1 BLISTER PACK in 1 CARTON (50090-2195-2) / 2 TABLET in 1 BLISTER PACK | 1 blister pack | 2015-10-27 | 0000-00-00 | No | No | Current |
| 50090-2195-3 | 50090219503 | 1 BLISTER PACK in 1 CARTON (50090-2195-3) / 4 TABLET in 1 BLISTER PACK | 1 blister pack | 2019-11-05 | 0000-00-00 | No | No | Current |