NDC codes

FDA NDC Directory
Product NDC (as listed)82804-146Labeler and product segments. Claims need a package NDC.
Product NDC at billing width82804-0146Add 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
82804-146-0682804014606828040146066 TABLET in 1 BOTTLE (82804-146-06)Marketed from Sep 8, 2025
82804-146-30828040146308280401463030 TABLET in 1 BOTTLE (82804-146-30)Marketed from Oct 4, 2024

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 — 200 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Proficient Rx LPNDC labeler code 82804
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 82804-146_df8a97c4-4546-48d0-b0f1-d0189224cea5SPL ID df8a97c4-4546-48d0-b0f1-d0189224cea5SPL set ID fef2222c-5d61-435e-8761-d8f3d435d6d8RxCUI 197700UNII 8VZV102JFYUPC 0382804146307
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

N482804014606 followed by a unit qualifier and the quantity

Package 82804-0146-06. 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 Error! Hyperlink reference not valid. section. Studies comparing fluconazole tablets to amphotericin B in n…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 82804-146

What is NDC 82804-146?
82804-146 is the product NDC for Fluconazole, Fluconazole 200 mg/1 tablet, listed with the FDA by Proficient Rx LP. It has 2 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?
Proficient Rx LP, NDC labeler code 82804. 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?
156 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 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
FluconazoleFluconazole 150 mg/1TabletOralREMEDYREPACK INC.70518-433670518-4336-00
FluconazoleFluconazole 150 mg/1TabletOralREMEDYREPACK INC.70518-433270518-4332-00

All 157 Fluconazole NDCs

Other NDCs under ANDA 077731

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

FDA NDC Directory listings under ANDA 077731
ProductStrengthForm · routeLabelerProduct NDC
FluconazoleFluconazole 150 mg/1TabletOralNorthwind Health Company, LLC51655-435
FluconazoleFluconazole 150 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-3578
FluconazoleFluconazole 150 mg/1TabletOralProficient Rx LP63187-584
FluconazoleFluconazole 50 mg/1TabletOralASCLEMED USA INC.87063-203
FluconazoleFluconazole 100 mg/1TabletOralASCLEMED USA INC.87063-204
FluconazoleFluconazole 150 mg/1TabletOralASCLEMED USA INC.87063-205
FluconazoleFluconazole 200 mg/1TabletOralASCLEMED USA INC.87063-206
FluconazoleFluconazole 150 mg/1TabletOralBryant Ranch Prepack71335-1268
FluconazoleFluconazole 200 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-8526
FluconazoleFluconazole 150 mg/1TabletOralA-S Medication Solutions50090-6842
FluconazoleFluconazole 150 mg/1TabletOralA-S Medication Solutions50090-2195
FluconazoleFluconazole 100 mg/1TabletOralREMEDYREPACK INC.70518-4242
FluconazoleFluconazole 150 mg/1TabletOralProficient Rx LP71205-563
FluconazoleFluconazole 50 mg/1TabletOralREMEDYREPACK INC.70518-4723
FluconazoleFluconazole 100 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.43063-645
FluconazoleFluconazole 150 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.43063-642
FluconazoleFluconazole 150 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-7293
FluconazoleFluconazole 50 mg/1TabletOralRising Pharma Holdings, Inc.57237-003
FluconazoleFluconazole 100 mg/1TabletOralRising Pharma Holdings, Inc.57237-004
FluconazoleFluconazole 150 mg/1TabletOralRising Pharma Holdings, Inc.57237-005

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