Prescription drug · ANDA
Itraconazole NDC 46708-204
Itraconazole 100 mg/1 · Capsule · Oral · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-204-04 | 46708020404 | 28 CAPSULE in 1 CARTON (46708-204-04)Marketed from Dec 16, 2016 | |
| 46708-204-10 | 46708020410 | 100 CAPSULE in 1 CARTON (46708-204-10)Marketed from Dec 16, 2016 | |
| 46708-204-30 | 46708020430 | 30 CAPSULE in 1 BOTTLE (46708-204-30)Marketed from Dec 16, 2016 | |
| 46708-204-71 | 46708020471 | 500 CAPSULE in 1 BOTTLE (46708-204-71)Marketed from Dec 16, 2016 | |
| 46708-204-90 | 46708020490 | 90 CAPSULE in 1 BOTTLE (46708-204-90)Marketed from Dec 16, 2016 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Itraconazole
- Generic name (nonproprietary)
- itraconazole
- Active ingredients
- Itraconazole — 100 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Alembic Pharmaceuticals LimitedNDC labeler code 46708
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206741
- Marketing start
- Listing expires
- Other FDA classes
- Azoles (Chemical structure)Breast Cancer Resistance Protein Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
- Identifiers
- Product ID 46708-204_13a86518-48bc-421b-ad49-c253bd65b488SPL ID 13a86518-48bc-421b-ad49-c253bd65b488SPL set ID f9d8b5a7-435f-40e6-8596-5f2376b92c74RxCUI 311204UNII 304NUG5GF4UPC 0346708204303
- Pharmacologic class
- Azole Antifungal
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N446708020404followed by a unit qualifier and the quantityPackage 46708-0204-04. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Itraconazole capsules are indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised patients: 1. Blastomycosis, pulmonary and extrapulmonary 2. Histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non- meningeal histoplasmosis, and 3. Aspergillosis, pulmonary and extrapulmonary, in patients who are intolerant of or who are refractory to amphotericin B therapy. Specimens for fungal cultures and other relevant laboratory studies (wet mount, histopathology, serology) should be obtained before therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the …
Excerpt only. Read the full label for complete information.
About NDC 46708-204
- What is NDC 46708-204?
- 46708-204 is the product NDC for Itraconazole, Itraconazole 100 mg/1 capsule, listed with the FDA by Alembic Pharmaceuticals Limited. It has 5 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Itraconazole.
- What is the active ingredient?
- Itraconazole.
- Who is the labeler?
- Alembic Pharmaceuticals Limited, NDC labeler code 46708. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Itraconazole?
- 11 other product NDCs are listed under this name. See all Itraconazole NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Itraconazole products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Itraconazole | Itraconazole 100 mg/1 | CapsuleOral | Rising Pharma Holdings, Inc. | 16571-245 | 16571-0245-03 |
| Itraconazole | Itraconazole 10 mg/mL | SolutionOral | Camber Pharmaceuticals, Inc. | 31722-006 | 31722-0006-31 |
| Itraconazole | Itraconazole 100 mg/1 | CapsuleOral | Torrent Pharmaceuticals Limited | 13668-463 | 13668-0463-0513668-0463-3013668-0463-37+1 more |
| Itraconazole | Itraconazole 100 mg/1 | CapsuleOral | AvPAK | 50268-450 | 50268-0450-12 |
| Itraconazole | Itraconazole 100 mg/1 | Capsule, Coated pelletsOral | NorthStar RxLLC | 16714-743 | 16714-0743-0116714-0743-02 |
| Itraconazole | Itraconazole 100 mg/1 | Capsule, Coated pelletsOral | Ascend Laboratories, LLC | 67877-454 | 67877-0454-0567877-0454-3067877-0454-84+1 more |
| Itraconazole | Itraconazole 100 mg/1 | CapsuleOral | American Health Packaging | 60687-299 | 60687-0299-25 |
| Itraconazole | Itraconazole 100 mg/1 | CapsuleOral | Alembic Pharmaceuticals Inc. | 62332-204 | 62332-0204-0462332-0204-1062332-0204-30+2 more |
| Itraconazole | Itraconazole 100 mg/1 | CapsuleOral | Amneal Pharmaceuticals LLC | 65162-630 | 65162-0630-03 |
| Itraconazole | Itraconazole 10 mg/mL | SolutionOral | Amneal Pharmaceuticals LLC | 65162-087 | 65162-0087-3465162-0087-74 |
Other NDCs under ANDA 206741
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Itraconazole | Itraconazole 100 mg/1 | CapsuleOral | Alembic Pharmaceuticals Inc. | 62332-204 |