Prescription drug · ANDA
Itraconazole NDC 31722-006
Itraconazole 10 mg/mL · Solution · Oral · Camber Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-006-31 | 31722000631 | 1 BOTTLE, GLASS in 1 CARTON (31722-006-31) / 150 mL in 1 BOTTLE, GLASSMarketed from Sep 1, 2020 |
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 — 10 mg/mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Camber Pharmaceuticals, Inc.NDC labeler code 31722
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212239
- 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 31722-006_2cd3622f-a50f-ec9c-e063-6294a90a3a30SPL ID 2cd3622f-a50f-ec9c-e063-6294a90a3a30SPL set ID 5af0b33d-bfa6-420b-86f0-067f95b402b2RxCUI 348506UNII 304NUG5GF4UPC 0331722006316
- 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
N431722000631followed by a unit qualifier and the quantityPackage 31722-0006-31. 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 oral solution is indicated for the treatment of oropharyngeal and esophageal candidiasis. (See CLINICAL PHARMACOLOGY : Special Populations, WARNINGS , and ADVERSE REACTIONS : Postmarketing Experience for more information.)
Excerpt only. Read the full label for complete information.
About NDC 31722-006
- What is NDC 31722-006?
- 31722-006 is the product NDC for Itraconazole, Itraconazole 10 mg/mL solution, listed with the FDA by Camber Pharmaceuticals, Inc.. It has 1 package NDC, 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?
- Camber Pharmaceuticals, Inc., NDC labeler code 31722. 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 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 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 212239
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 Oralitraconazole | Itraconazole 10 mg/mL | SolutionOral | Natco Pharma USA LLC | 69339-159 |