voriconazole
- Product NDC
- 43386-088
- 11-digit product format
- 433860088
- Labeler code
- 43386
- Product ID
- 43386-088_56ca1aed-0ee1-4afa-8bc3-a6d5f503ba6e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- voriconazole
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals,Inc.
- Application
- ANDA207371
- Marketing category
- ANDA
- Marketing start
- 2016-05-24
- 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 |
|---|
| 43386-088-03 | voriconazole | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 14 |
| 43386-088-05 | voriconazole | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 14 |
| 43386-088-30 | voriconazole | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 14 |
| 43386-088-31 | voriconazole | 3 in 1 CARTON | TABLET, FILM COATED | 3 | | 14 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43386-088 | VORICONAZOLE TABLET, FILM COATED [LUPIN PHARMACEUTICALS,INC.] | 14 | Current NDC, Legacy NDC, 4 package rows | 20240201_b4c934c0-c1bb-4b0a-bc32-fb9e77ef65fc.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 |
|---|
| 43386-088-03 | 43386008803 | 30 TABLET, FILM COATED in 1 BOTTLE (43386-088-03) | | 2016-05-24 | 0000-00-00 | No | No | Current |
| 43386-088-05 | 43386008805 | 500 TABLET, FILM COATED in 1 BOTTLE (43386-088-05) | | 2016-05-24 | 0000-00-00 | No | No | Current |
| 43386-088-30 | 43386008830 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 43386-088-31 | 43386008831 | 3 BLISTER PACK in 1 CARTON (43386-088-31) > 10 TABLET, FILM COATED in 1 BLISTER PACK (43386-088-30) | 3 blister pack | 2016-05-24 | 0000-00-00 | No | No | Current |