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NDC 13668-0463-37 Itraconazole 100 mg/1 Details
Itraconazole 100 mg/1
Itraconazole is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Torrent Pharmaceuticals Limited. The primary component is ITRACONAZOLE.
Product Information
| NDC | 13668-0463 |
|---|---|
| Product ID | 13668-463_7c8c2315-1c52-4020-9ac2-e92646a7bab1 |
| Associated GPIs | 11407035000120 |
| GCN Sequence Number | 016949 |
| GCN Sequence Number Description | itraconazole CAPSULE 100 MG ORAL |
| HIC3 | W3B |
| HIC3 Description | ANTIFUNGAL AGENTS |
| GCN | 49101 |
| HICL Sequence Number | 006503 |
| HICL Sequence Number Description | ITRACONAZOLE |
| Brand/Generic | Generic |
| Proprietary Name | Itraconazole |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Itraconazole |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE |
| Route | ORAL |
| Active Ingredient Strength | 100 |
| Active Ingredient Units | mg/1 |
| Substance Name | ITRACONAZOLE |
| Labeler Name | Torrent Pharmaceuticals Limited |
| Pharmaceutical Class | Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA209460 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 13668-0463-37 (13668046337)
| NDC Package Code | 13668-463-37 |
|---|---|
| Billing NDC | 13668046337 |
| Package | 28 CAPSULE in 1 CARTON (13668-463-37) |
| Marketing Start Date | 2018-08-24 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |