Prescription drug · ANDA
fluconazole NDC 72189-149
Fluconazole 150 mg/1 · Tablet · Oral · direct rx
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-149-01 | 72189014901 | 1 TABLET in 1 BLISTER PACK (72189-149-01)Marketed from Nov 11, 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)
- fluconazole
- Generic name (nonproprietary)
- fluconazole
- Active ingredients
- Fluconazole — 150 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- direct rx
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208963
- 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 72189-149_2becff06-7cc2-1200-e063-6294a90ad1ecSPL ID 2becff06-7cc2-1200-e063-6294a90ad1ecSPL set ID b3db505a-9677-6f5a-e053-2a95a90a13d4RxCUI 197698, 197699UNII 8VZV102JFY
- 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
N472189014901followed by a unit qualifier and the quantityPackage 72189-0149-01. 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)
Fluconazole tablets are indicated for the treatment of: Vaginal candidiasis (vaginal yeast infections due to Candida). 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. 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 patients have not been conducted. Proph…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 208963
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 100 mg/1 | TabletOral | A-S Medication Solutions | 50090-5299 |
| fluconazole | Fluconazole 150 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1065 |
| fluconazole | Fluconazole 150 mg/1 | TabletOral | A-S Medication Solutions | 50090-4425 |
| fluconazole | Fluconazole 50 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1063 |
| fluconazole | Fluconazole 100 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1064 |
| fluconazole | Fluconazole 200 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1066 |
| fluconazole | Fluconazole 100 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4501 |
| fluconazole | Fluconazole 50 mg/1 | TabletOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1137 |
| fluconazole | Fluconazole 200 mg/1 | TabletOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1140 |
| fluconazole | Fluconazole 100 mg/1 | TabletOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1138 |
| fluconazole | Fluconazole 150 mg/1 | TabletOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1139 |
| Fluconazole | Fluconazole 100 mg/1 | TabletOral | direct rx | 72189-140 |
| fluconazole | Fluconazole 150 mg/1 | TabletOral | Proficient Rx LP | 71205-081 |
| Fluconazole | Fluconazole 200 mg/1 | TabletOral | Direct Rx | 61919-493 |
| fluconazole | Fluconazole 100 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2415 |
| fluconazole | Fluconazole 200 mg/1 | TabletOral | A-S Medication Solutions | 50090-4864 |
| fluconazole | Fluconazole 100 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0686 |
| fluconazole | Fluconazole 200 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0769 |
| fluconazole | Fluconazole 200 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4163 |
| fluconazole | Fluconazole 200 mg/1 | TabletOral | Proficient Rx LP | 71205-283 |