Prescription drug · ANDA
Itraconazole NDC 16714-743
Itraconazole 100 mg/1 · Capsule, Coated pellets · Oral · NorthStar RxLLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16714-743-01 | 16714074301 | 7 BLISTER PACK in 1 CARTON (16714-743-01) / 4 CAPSULE, COATED PELLETS in 1 BLISTER PACKMarketed from Sep 1, 2017 | |
| 16714-743-02 | 16714074302 | 30 CAPSULE, COATED PELLETS in 1 BOTTLE (16714-743-02)Marketed from Sep 1, 2017 |
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, Coated pellets
- Route
- Oral
- Labeler
- NorthStar RxLLCNDC labeler code 16714
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208591
- 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 16714-743_62530d1a-98c7-4605-a95e-4bdf1b4f3d7cSPL ID 62530d1a-98c7-4605-a95e-4bdf1b4f3d7cSPL set ID 46732a10-1f0d-4022-9689-256c44683e96RxCUI 311204UNII 304NUG5GF4
- 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
N416714074301followed by a unit qualifier and the quantityPackage 16714-0743-01. 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 c…
Excerpt only. Read the full label for complete information.
About NDC 16714-743
- What is NDC 16714-743?
- 16714-743 is the product NDC for Itraconazole, Itraconazole 100 mg/1 capsule, coated pellets, listed with the FDA by NorthStar RxLLC. It has 2 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?
- NorthStar RxLLC, NDC labeler code 16714. 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 | 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 Limited | 46708-204 | 46708-0204-0446708-0204-1046708-0204-30+2 more |
| 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 208591
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 | Capsule, Coated pelletsOral | Ascend Laboratories, LLC | 67877-454 |