Fluconazole
- Product NDC
- 21695-560
- 11-digit product format
- 216950560
- Labeler code
- 21695
- Product ID
- 21695-560_8e80f9d8-2577-4fd9-a455-e6c6dc244c3a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluconazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rebel Distributors Corp
- Application
- ANDA077253
- Marketing category
- ANDA
- Marketing start
- 2006-01-25
- Marketing end
- 0000-00-00
- Substance
- FLUCONAZOLE
- Active strength
- 200 mg/1
- Pharmacologic classes
- Azole Antifungal [EPC],Azoles [CS],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
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 |
|---|---|---|---|---|---|
| 21695-560-07 | 2019-09-24 | C162847 | 48780-1 | 934fe258-482a-48b1-e053-8cdaa90a720a | Fluconazole Tablets USP |
| 21695-560-30 | 2019-09-24 | C162847 | 48780-1 | 934fe258-482a-48b1-e053-8cdaa90a720a | Fluconazole Tablets USP |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-560-07 | Fluconazole | 7 in 1 BOTTLE | TABLET | 7 | 1 | |
| 21695-560-30 | Fluconazole | 30 in 1 BOTTLE | TABLET | 30 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21695-560-07 | EA - Each | 21695-560 | b4569911-c8cf-480b-86e5-50c23afd53ac | 1 | 2012-07-24 |
| 21695-560-30 | EA - Each | 21695-560 | 547ee83a-4ca6-4cb3-b254-38bc2ba81f3f | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| FLUCONAZOLE | ACTIVE INGREDIENT | 8VZV102JFY | FLUCONAZOLE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| FLUCONAZOLE | ACTIVE MOIETY | 8VZV102JFY | FLUCONAZOLE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| ANHYDROUS DIBASIC CALCIUM PHOSPHATE | INACTIVE INGREDIENT | L11K75P92J | FLUCONAZOLE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | FLUCONAZOLE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | FLUCONAZOLE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | FLUCONAZOLE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | FLUCONAZOLE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | FLUCONAZOLE TABLET [REBEL DISTRIBUTORS CORP] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197698 | fluconazole 100 MG Oral Tablet | PSN | 8e80f9d8-2577-4fd9-a455-e6c6dc244c3a | 1 |
| 197699 | fluconazole 150 MG Oral Tablet | PSN | 8e80f9d8-2577-4fd9-a455-e6c6dc244c3a | 1 |
| 197700 | fluconazole 200 MG Oral Tablet | PSN | 8e80f9d8-2577-4fd9-a455-e6c6dc244c3a | 1 |
| 197698 | fluconazole 100 MG Oral Tablet | SCD | 8e80f9d8-2577-4fd9-a455-e6c6dc244c3a | 1 |
| 197699 | fluconazole 150 MG Oral Tablet | SCD | 8e80f9d8-2577-4fd9-a455-e6c6dc244c3a | 1 |
| 197700 | fluconazole 200 MG Oral Tablet | SCD | 8e80f9d8-2577-4fd9-a455-e6c6dc244c3a | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 21695-560-07 | 21695056007 | 7 in 1 BOTTLE | Historical |
| 21695-560-30 | 21695056030 | 30 in 1 BOTTLE | Historical |