Prescription drug · ANDA
Fluconazole NDC 16714-695
Fluconazole 10 mg/mL · Powder, For suspension · Oral · NorthStar Rx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16714-695-01 | 1671406950116714069501 | 1 BOTTLE in 1 CARTON (16714-695-01) / 35 mL in 1 BOTTLEMarketed from Sep 18, 2009 |
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)
- Fluconazole
- Generic name (nonproprietary)
- fluconazole
- Active ingredients
- Fluconazole — 10 mg/mL
- Dosage form
- Powder, For suspension
- Route
- Oral
- Labeler
- NorthStar Rx LLCNDC labeler code 16714
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 079150
- Marketing start
- Listing expires
- Other FDA classes
- Azoles (Chemical structure)Cytochrome P450 2C19 Inhibitors (Mechanism)Cytochrome P450 2C9 Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)
- Identifiers
- Product ID 16714-695_95e12350-efed-4dad-8ec3-6aa48fdc1512SPL ID 95e12350-efed-4dad-8ec3-6aa48fdc1512SPL set ID afde17e7-b95b-4cd5-97eb-e361724014bdRxCUI 310352, 310353UNII 8VZV102JFYUPC 0316714696010
- 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
N416714069501followed by a unit qualifier and the quantityPackage 16714-0695-01. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE Fluconazole for oral suspension is indicated for the treatment of: Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole for oral suspension was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. Cryptococcal meningitis . Before prescribing fluconazole for oral suspension for AIDS patients with cryptococcal meningitis , please see CLINICAL STUDIES section. Studies comparing fluconazole for oral suspension to amphotericin B in non-HIV infected patients have not been conducted…
Excerpt only. Read the full label for complete information.
About NDC 16714-695
- What is NDC 16714-695?
- 16714-695 is the product NDC for Fluconazole, Fluconazole 10 mg/mL powder, for suspension, listed with the FDA by NorthStar Rx LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Fluconazole.
- What is the active ingredient?
- Fluconazole.
- Who is the labeler?
- NorthStar Rx LLC, 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 Fluconazole?
- 162 other product NDCs are listed under this name. See all Fluconazole NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Fluconazole products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Fluconazole | Fluconazole 200 mg/1 | TabletOral | Coupler LLC | 67046-2044 | 67046-2044-03 |
| Fluconazole | Fluconazole 100 mg/1 | TabletOral | Coupler LLC | 67046-0623 | 67046-0623-03 |
| Fluconazole | Fluconazole 50 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4723 | 70518-4723-00 |
| fluconazole | Fluconazole 200 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4163 | 68788-4163-0068788-4163-0168788-4163-02+4 more |
| Fluconazole | Fluconazole 100 mg/1 | TabletOral | Coupler LLC | 67046-2000 | 67046-2000-03 |
| Fluconazole | Fluconazole 50 mg/1 | TabletOral | Radha Pharmaceuticals Inc | 77771-396 | 77771-0396-30 |
| Fluconazole | Fluconazole 100 mg/1 | TabletOral | Radha Pharmaceuticals Inc | 77771-397 | 77771-0397-0177771-0397-30 |
| Fluconazole | Fluconazole 150 mg/1 | TabletOral | Radha Pharmaceuticals Inc | 77771-398 | 77771-0398-1177771-0398-13 |
| Fluconazole | Fluconazole 200 mg/1 | TabletOral | Radha Pharmaceuticals Inc | 77771-399 | 77771-0399-0177771-0399-30 |
| Fluconazole | Fluconazole 100 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4413 | 70518-4413-00 |
Other NDCs under ANDA 079150
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 |
|---|---|---|---|---|
| Fluconazole | Fluconazole 40 mg/mL | Powder, For suspensionOral | NorthStar Rx LLC | 16714-696 |
| Fluconazole | Fluconazole 10 mg/mL | Powder, For suspensionOral | Rising Pharma Holdings, Inc. | 57237-149 |
| Fluconazole | Fluconazole 40 mg/mL | Powder, For suspensionOral | Rising Pharma Holdings, Inc. | 57237-150 |
| Fluconazole | Fluconazole 10 mg/mL | Powder, For suspensionOral | Aurobindo Pharma Limited | 65862-299 |
| Fluconazole | Fluconazole 40 mg/mL | Powder, For suspensionOral | Aurobindo Pharma Limited | 65862-300 |