Prescription drug · ANDA
Fluconazole NDC 71335-2235
Fluconazole 200 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-2235-0 | 7133522350071335223500 | 4 TABLET in 1 BOTTLE (71335-2235-0)Marketed from Sep 18, 2023 | |
| 71335-2235-1 | 7133522350171335223501 | 30 TABLET in 1 BOTTLE (71335-2235-1)Marketed from May 6, 2024 | |
| 71335-2235-2 | 7133522350271335223502 | 12 TABLET in 1 BOTTLE (71335-2235-2)Marketed from Sep 6, 2024 | |
| 71335-2235-3 | 7133522350371335223503 | 100 TABLET in 1 BOTTLE (71335-2235-3)Marketed from Sep 6, 2024 | |
| 71335-2235-4 | 7133522350471335223504 | 3 TABLET in 1 BOTTLE (71335-2235-4)Marketed from Sep 6, 2024 | |
| 71335-2235-5 | 7133522350571335223505 | 28 TABLET in 1 BOTTLE (71335-2235-5)Marketed from Sep 6, 2024 | |
| 71335-2235-6 | 7133522350671335223506 | 1 TABLET in 1 BOTTLE (71335-2235-6)Marketed from Sep 6, 2024 | |
| 71335-2235-7 | 7133522350771335223507 | 2 TABLET in 1 BOTTLE (71335-2235-7)Marketed from Oct 16, 2023 | |
| 71335-2235-8 | 7133522350871335223508 | 14 TABLET in 1 BOTTLE (71335-2235-8)Marketed from Oct 11, 2023 | |
| 71335-2235-9 | 7133522350971335223509 | 8 TABLET in 1 BOTTLE (71335-2235-9)Marketed from Sep 6, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 200 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 71335
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077731
- 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 71335-2235_29b45641-c685-4ae8-accb-23784c01ee86SPL ID 29b45641-c685-4ae8-accb-23784c01ee86SPL set ID 3f743514-615e-4e78-8321-24c545a7752fRxCUI 197700UNII 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
N471335223500followed by a unit qualifier and the quantityPackage 71335-2235-00. 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: 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 …
Excerpt only. Read the full label for complete information.
About NDC 71335-2235
- What is NDC 71335-2235?
- 71335-2235 is the product NDC for Fluconazole, Fluconazole 200 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 10 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?
- Bryant Ranch Prepack, NDC labeler code 71335. 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 077731
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 | Aurobindo Pharma Limited | 65862-059 |
| Fluconazole | Fluconazole 50 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-058 |
| Fluconazole | Fluconazole 200 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4020 |
| Fluconazole | Fluconazole 200 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3428 |
| Fluconazole | Fluconazole 100 mg/1 | TabletOral | American Health Packaging | 68084-728 |
| Fluconazole | Fluconazole 100 mg/1 | TabletOral | A-S Medication Solutions | 50090-1429 |
| Fluconazole | Fluconazole 200 mg/1 | TabletOral | American Health Packaging | 68084-735 |
| Fluconazole | Fluconazole 100 mg/1 | TabletOral | NorthStar Rx LLC | 16714-691 |
| Fluconazole | Fluconazole 150 mg/1 | TabletOral | NorthStar Rx LLC | 16714-692 |
| Fluconazole | Fluconazole 200 mg/1 | TabletOral | NorthStar Rx LLC | 16714-693 |
| Fluconazole | Fluconazole 50 mg/1 | TabletOral | NorthStar Rx LLC | 16714-694 |
| Fluconazole | Fluconazole 150 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3474 |
| Fluconazole | Fluconazole 150 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3515 |
| Fluconazole | Fluconazole 100 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3768 |
| Fluconazole | Fluconazole 150 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-950 |
| Fluconazole | Fluconazole 200 mg/1 | TabletOral | Direct_Rx | 72189-516 |
| Fluconazole | Fluconazole 200 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3547 |
| Fluconazole | Fluconazole 150 mg/1 | TabletOral | Proficient Rx LP | 63187-584 |
| Fluconazole | Fluconazole 100 mg/1 | TabletOral | Sportpharm LLC | 85766-157 |
| Fluconazole | Fluconazole 50 mg/1 | TabletOral | Sportpharm LLC | 85766-156 |
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