Prescription drug · ANDA

Fluconazole NDC 55154-3400

Fluconazole 100 mg/1 · Tablet · Oral · Cardinal Health 107, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)55154-3400Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55154-3400Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
55154-3400-05515434000010 BLISTER PACK in 1 BAG (55154-3400-0) / 1 TABLET in 1 BLISTER PACKMarketed from Jun 25, 2015

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 — 100 mg/1
Dosage form
Tablet
Route
Oral
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 55154-3400_021021a2-991b-48bc-b217-aa08eb530829SPL ID 021021a2-991b-48bc-b217-aa08eb530829SPL set ID f1bfba3a-5b18-41c0-9084-b1f26bb93ef2RxCUI 197698, 197700UNII 8VZV102JFYUPC 0055154340007, 0055154787505
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

N455154340000 followed by a unit qualifier and the quantity

Package 55154-3400-00. 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: 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 076658

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 076658
ProductStrengthForm · routeLabelerProduct NDC
FluconazoleFluconazole 150 mg/1TabletOralBryant Ranch Prepack71335-1448
FluconazoleFluconazole 200 mg/1TabletOralDr. Reddy's Laboratories Limited55111-146
FluconazoleFluconazole 150 mg/1TabletOraldirect rx72189-143
FluconazoleFluconazole 200 mg/1TabletOralSportpharm LLC85766-104
FluconazoleFluconazole 50 mg/1TabletOralSportpharm LLC85766-101
FluconazoleFluconazole 100 mg/1TabletOralSportpharm LLC85766-102
FluconazoleFluconazole 150 mg/1TabletOralSportpharm LLC85766-103
FluconazoleFluconazole 100 mg/1TabletOralMajor Pharmaceuticals0904-6500
FluconazoleFluconazole 200 mg/1TabletOralMajor Pharmaceuticals0904-6501
FluconazoleFluconazole 150 mg/1TabletOralDr. Reddy's Laboratories Limited55111-145
FluconazoleFluconazole 50 mg/1TabletOralDr. Reddy's Laboratories Limited55111-143
FluconazoleFluconazole 100 mg/1TabletOralDr. Reddy's Laboratories Limited55111-144
FluconazoleFluconazole 200 mg/1TabletOralCardinal Health 107, LLC55154-7875

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Fluconazole NDC 55154-3400 | Med-Code