Fluconazole
- Product NDC
- 68258-3036
- 11-digit product format
- 682583036
- Labeler code
- 68258
- Product ID
- 68258-3036_db169f6d-67b5-4328-9796-fdf7a57422be
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluconazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Dispensing Solutions Inc.
- Application
- ANDA077253
- Marketing category
- ANDA
- Marketing start
- 2004-09-23
- Marketing end
- 0000-00-00
- Substance
- FLUCONAZOLE
- Active strength
- 150 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 |
|---|---|---|---|---|---|
| 68258-3036-2 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-c117-621f-e053-dbdaa90a74ad | Fluconazole Tablets |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68258-3036-2 | Fluconazole | 1 in 1 BLISTER PACK | TABLET | 1 | 1 | |
| 68258-3036-2 | Fluconazole | 2 in 1 CARTON | TABLET | 2 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68258-3036-2 | EA - Each | 68258-3036 | 74b98309-6794-461a-a68b-c30b644f8a6a | 1 | 2013-08-02 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| FLUCONAZOLE | ACTIVE INGREDIENT | 8VZV102JFY | FLUCONAZOLE TABLET [DISPENSING SOLUTIONS INC.] | 1 | |
| FLUCONAZOLE | ACTIVE MOIETY | 8VZV102JFY | FLUCONAZOLE TABLET [DISPENSING SOLUTIONS INC.] | 1 | |
| ANHYDROUS DIBASIC CALCIUM PHOSPHATE | INACTIVE INGREDIENT | L11K75P92J | FLUCONAZOLE TABLET [DISPENSING SOLUTIONS INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | FLUCONAZOLE TABLET [DISPENSING SOLUTIONS INC.] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | FLUCONAZOLE TABLET [DISPENSING SOLUTIONS INC.] | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | FLUCONAZOLE TABLET [DISPENSING SOLUTIONS INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | FLUCONAZOLE TABLET [DISPENSING SOLUTIONS INC.] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | FLUCONAZOLE TABLET [DISPENSING SOLUTIONS INC.] | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68258-3036 | FLUCONAZOLE TABLET [DISPENSING SOLUTIONS INC.] | 1 | Legacy NDC, 2 package rows | 20100303_5d8db96a-c0f5-44c5-aadd-72433ea30e46.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197699 | fluconazole 150 MG Oral Tablet | PSN | 5d8db96a-c0f5-44c5-aadd-72433ea30e46 | 1 |
| 197699 | fluconazole 150 MG Oral Tablet | SCD | 5d8db96a-c0f5-44c5-aadd-72433ea30e46 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 68258-3036-2 | 68258303602 | 1 in 1 BLISTER PACK | Historical |