Voriconazole
- Product NDC
- 51079-164
- 11-digit product format
- 510790164
- Labeler code
- 51079
- Product ID
- 51079-164_3a879fbf-a5ce-949d-e063-6394a90a90d5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- voriconazole
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Mylan Institutional Inc.
- Application
- ANDA090547
- Marketing category
- ANDA
- Marketing start
- 2011-08-08
- Substance
- VORICONAZOLE
- Active strength
- 50 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
- Voriconazole
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| VORICONAZOLE | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | JFU09I87TR |
| Rxcui | 349434, 349435 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51079-164-01 | Voriconazole | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 15 |
| 51079-164-03 | Voriconazole | 30 in 1 CARTON | TABLET, FILM COATED | 30 | | 15 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| VORICONAZOLE | ACTIVE INGREDIENT | JFU09I87TR | VORICONAZOLE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 6 | |
| VORICONAZOLE | ACTIVE MOIETY | JFU09I87TR | VORICONAZOLE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 6 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | VORICONAZOLE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 6 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | VORICONAZOLE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 6 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | VORICONAZOLE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 6 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | VORICONAZOLE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 6 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | VORICONAZOLE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 6 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | VORICONAZOLE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 6 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | VORICONAZOLE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 6 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | VORICONAZOLE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51079-164 | VORICONAZOLE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 14 | Current NDC, Legacy NDC, 2 package rows | 20250129_3af8cfe6-1c0d-4b57-ae31-05cffa64132e.zip |
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 |
|---|
| 51079-164-01 | 51079016401 | 1 in 1 BLISTER PACK | | | | | | Historical |
| 51079-164-03 | 51079016403 | 30 BLISTER PACK in 1 CARTON (51079-164-03) / 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-164-01) | 30 blister pack | 2011-08-08 | 0000-00-00 | No | No | Current |