Prescription drug · ANDA
Fluconazole NDC 71205-796
Fluconazole 150 mg/1 · Tablet · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-796-01 | 71205079601 | 1 BLISTER PACK in 1 BAG (71205-796-01) / 1 TABLET in 1 BLISTER PACKMarketed from Apr 28, 2023 | |
| 71205-796-02 | 71205079602 | 2 BLISTER PACK in 1 BAG (71205-796-02) / 1 TABLET in 1 BLISTER PACKMarketed from Apr 28, 2023 |
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 — 150 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Proficient Rx LPNDC labeler code 71205
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077253
- 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 71205-796_fa2fa2f8-f3a6-4bc0-943c-03dabd0f1581SPL ID fa2fa2f8-f3a6-4bc0-943c-03dabd0f1581SPL set ID fa2fa2f8-f3a6-4bc0-943c-03dabd0f1581RxCUI 197699UNII 8VZV102JFYUPC 0371205796013
- 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
N471205079601followed by a unit qualifier and the quantityPackage 71205-0796-01. 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 tablets are indicated for the treatment of: 1. Vaginal candidiasis (vaginal yeast infections due to Candida ). 2. Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. 3. Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patient…
Excerpt only. Read the full label for complete information.
About NDC 71205-796
- What is NDC 71205-796?
- 71205-796 is the product NDC for Fluconazole, Fluconazole 150 mg/1 tablet, listed with the FDA by Proficient Rx LP. It has 2 package NDCs, 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?
- Proficient Rx LP, NDC labeler code 71205. 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?
- 160 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 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 100 mg/1 | TabletOral | Radha Pharmaceuticals Inc | 77771-397 | 77771-0397-0177771-0397-30 |
| Fluconazole | Fluconazole 50 mg/1 | TabletOral | Radha Pharmaceuticals Inc | 77771-396 | 77771-0396-30 |
| 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 |
| Fluconazole | Fluconazole 150 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4336 | 70518-4336-00 |
| Fluconazole | Fluconazole 150 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4332 | 70518-4332-00 |
Other NDCs under ANDA 077253
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 150 mg/1 | TabletOral | A-S Medication Solutions | 50090-5764 |
| Fluconazole | Fluconazole 100 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4413 |
| Fluconazole | Fluconazole 100 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-889 |
| Fluconazole | Fluconazole 150 mg/1 | TabletOral | Direct Rx | 72189-342 |
| Fluconazole | Fluconazole 150 mg/1 | TabletOral | Northwind Health Company, LLC | 82868-033 |
| Fluconazole | Fluconazole 100 mg/1 | TabletOral | Coupler LLC | 67046-2000 |
| Fluconazole | Fluconazole 100 mg/1 | TabletOral | Proficient Rx LP | 82804-218 |
| Fluconazole | Fluconazole 50 mg/1 | TabletOral | Glenmark Pharmaceuticals Inc., USA | 68462-101 |
| Fluconazole | Fluconazole 100 mg/1 | TabletOral | Glenmark Pharmaceuticals Inc., USA | 68462-102 |
| Fluconazole | Fluconazole 200 mg/1 | TabletOral | Glenmark Pharmaceuticals Inc., USA | 68462-104 |
| Fluconazole | Fluconazole 150 mg/1 | TabletOral | Glenmark Pharmaceuticals Inc., USA | 68462-119 |
| Fluconazole | Fluconazole 50 mg/1 | TabletOral | Coupler LLC | 67046-1546 |
| Fluconazole | Fluconazole 150 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-803 |
| Fluconazole | Fluconazole 150 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4332 |
| Fluconazole | Fluconazole 150 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-164 |
| Fluconazole | Fluconazole 200 mg/1 | TabletOral | BluePoint Laboratories | 68001-254 |
| Fluconazole | Fluconazole 50 mg/1 | TabletOral | BluePoint Laboratories | 68001-251 |
| Fluconazole | Fluconazole 100 mg/1 | TabletOral | BluePoint Laboratories | 68001-252 |
| Fluconazole | Fluconazole 150 mg/1 | TabletOral | BluePoint Laboratories | 68001-253 |
| Fluconazole | Fluconazole 150 mg/1 | TabletOral | Radha Pharmaceuticals Inc | 77771-398 |
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