NDC codes

FDA NDC Directory
Product NDC (as listed)71335-1448Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-1448Add 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
71335-1448-171335144801713351448011 TABLET in 1 DOSE PACK (71335-1448-1)Marketed from Jun 20, 2014

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 — 150 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 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 71335-1448_ef05e10f-f066-4d73-a4cc-fbd1790d2863SPL ID ef05e10f-f066-4d73-a4cc-fbd1790d2863SPL set ID a499c43e-0454-4a8c-a547-31e9816babddRxCUI 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

N471335144801 followed by a unit qualifier and the quantity

Package 71335-1448-01. 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.

Full label on DailyMed (opens in a new tab)

About NDC 71335-1448

What is NDC 71335-1448?
71335-1448 is the product NDC for Fluconazole, Fluconazole 150 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 1 package NDC, 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Fluconazole NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
FluconazoleFluconazole 200 mg/1TabletOralCoupler LLC67046-204467046-2044-03
FluconazoleFluconazole 100 mg/1TabletOralCoupler LLC67046-062367046-0623-03
FluconazoleFluconazole 50 mg/1TabletOralREMEDYREPACK INC.70518-472370518-4723-00
fluconazoleFluconazole 200 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-416368788-4163-0068788-4163-0168788-4163-02+4 more
FluconazoleFluconazole 100 mg/1TabletOralCoupler LLC67046-200067046-2000-03
FluconazoleFluconazole 50 mg/1TabletOralRadha Pharmaceuticals Inc77771-39677771-0396-30
FluconazoleFluconazole 100 mg/1TabletOralRadha Pharmaceuticals Inc77771-39777771-0397-0177771-0397-30
FluconazoleFluconazole 150 mg/1TabletOralRadha Pharmaceuticals Inc77771-39877771-0398-1177771-0398-13
FluconazoleFluconazole 200 mg/1TabletOralRadha Pharmaceuticals Inc77771-39977771-0399-0177771-0399-30
FluconazoleFluconazole 100 mg/1TabletOralREMEDYREPACK INC.70518-441370518-4413-00

All 163 Fluconazole NDCs

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 100 mg/1TabletOralMajor Pharmaceuticals0904-6500
FluconazoleFluconazole 200 mg/1TabletOralMajor Pharmaceuticals0904-6501
FluconazoleFluconazole 50 mg/1TabletOralDr. Reddy's Laboratories Limited55111-143
FluconazoleFluconazole 100 mg/1TabletOralDr. Reddy's Laboratories Limited55111-144
FluconazoleFluconazole 150 mg/1TabletOralDr. Reddy's Laboratories Limited55111-145
FluconazoleFluconazole 200 mg/1TabletOralDr. Reddy's Laboratories Limited55111-146
FluconazoleFluconazole 100 mg/1TabletOralCardinal Health 107, LLC55154-3400
FluconazoleFluconazole 200 mg/1TabletOralCardinal Health 107, LLC55154-7875
FluconazoleFluconazole 150 mg/1TabletOraldirect rx72189-143
FluconazoleFluconazole 50 mg/1TabletOralSportpharm LLC85766-101
FluconazoleFluconazole 100 mg/1TabletOralSportpharm LLC85766-102
FluconazoleFluconazole 150 mg/1TabletOralSportpharm LLC85766-103
FluconazoleFluconazole 200 mg/1TabletOralSportpharm LLC85766-104

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