Prescription drug · ANDA
Fluconazole NDC 55111-143
Fluconazole 50 mg/1 · Tablet · Oral · Dr. Reddy's Laboratories Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55111-143-01 | 5511101430155111014301 | 100 TABLET in 1 BOTTLE (55111-143-01)Marketed from Jun 20, 2014 | |
| 55111-143-05 | 5511101430555111014305 | 500 TABLET in 1 BOTTLE (55111-143-05)Marketed from Jun 20, 2014 | |
| 55111-143-30 | 5511101433055111014330 | 30 TABLET in 1 BOTTLE (55111-143-30)Marketed from Jun 20, 2014 | |
| 55111-143-78 | 5511101437855111014378 | 10 DOSE PACK in 1 CARTON (55111-143-78) / 10 TABLET in 1 DOSE PACK (55111-143-79)Marketed from Jun 20, 2014 |
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 — 50 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Dr. Reddy's Laboratories LimitedNDC labeler code 55111
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076658
- 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 55111-143_69e67aa4-a859-7ab0-79df-d9bf8489998dSPL ID 69e67aa4-a859-7ab0-79df-d9bf8489998dSPL set ID d7fa1d79-4cd3-4a55-b74b-b31e82e616a3RxCUI 197698, 197699, 197700, 197701UNII 8VZV102JFYUPC 0355111145127
- 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
N455111014301followed by a unit qualifier and the quantityPackage 55111-0143-01. 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 patients…
Excerpt only. Read the full label for complete information.
About NDC 55111-143
- What is NDC 55111-143?
- 55111-143 is the product NDC for Fluconazole, Fluconazole 50 mg/1 tablet, listed with the FDA by Dr. Reddy's Laboratories Limited. It has 4 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?
- Dr. Reddy's Laboratories Limited, NDC labeler code 55111. 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 076658
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 | Major Pharmaceuticals | 0904-6500 |
| Fluconazole | Fluconazole 200 mg/1 | TabletOral | Major Pharmaceuticals | 0904-6501 |
| Fluconazole | Fluconazole 100 mg/1 | TabletOral | Dr. Reddy's Laboratories Limited | 55111-144 |
| Fluconazole | Fluconazole 150 mg/1 | TabletOral | Dr. Reddy's Laboratories Limited | 55111-145 |
| Fluconazole | Fluconazole 200 mg/1 | TabletOral | Dr. Reddy's Laboratories Limited | 55111-146 |
| Fluconazole | Fluconazole 100 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-3400 |
| Fluconazole | Fluconazole 200 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-7875 |
| Fluconazole | Fluconazole 150 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1448 |
| Fluconazole | Fluconazole 150 mg/1 | TabletOral | direct rx | 72189-143 |
| Fluconazole | Fluconazole 50 mg/1 | TabletOral | Sportpharm LLC | 85766-101 |
| Fluconazole | Fluconazole 100 mg/1 | TabletOral | Sportpharm LLC | 85766-102 |
| Fluconazole | Fluconazole 150 mg/1 | TabletOral | Sportpharm LLC | 85766-103 |
| Fluconazole | Fluconazole 200 mg/1 | TabletOral | Sportpharm LLC | 85766-104 |