What is NDC 50268-337?

50268-337 is the product NDC for Fluconazole, Fluconazole 100 mg/1 tablet, listed with the FDA by AvPAK. It has 1 package NDC, shown above in 10- and 11-digit form.

AvPAK, NDC labeler code 50268. 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?

160 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Fluconazole NDC 50268-337 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)50268-337Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50268-0337Add 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 NDC	11-digit (billing)	Package	Copy
50268-337-15	50268033715	50 BLISTER PACK in 1 BOX (50268-337-15) / 1 TABLET in 1 BLISTER PACK (50268-337-11)Marketed from Sep 9, 2016

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 — 100 mg/1
Dosage form: Tablet
Route: Oral
Labeler: AvPAKNDC labeler code 50268
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077731
Marketing start: Sep 9, 2016
Listing expires: Dec 31, 2027
Other FDA classes: Azoles (Chemical structure)Cytochrome P450 2C19 Inhibitors (Mechanism)Cytochrome P450 2C9 Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)
Identifiers: Product ID 50268-337_47bacb91-b009-2ce7-e063-6394a90a0eacSPL ID 47bacb91-b009-2ce7-e063-6394a90a0eacSPL set ID 551a5c8f-57eb-2643-12c6-7c700584b49fRxCUI 197698, 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

N450268033715 followed by a unit qualifier and the quantity

Package 50268-0337-15. 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 Jan 6, 2026.

Indications (excerpt from the label)

INDICATIONS AND USAGE Fluconazole tablets USP 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 USP 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 USP for AIDS patients with cryptococcal meningitis , please see CLINICAL STUDIES section. Studies comparing fluconazole tablets USP to amphotericin B in non-HIV infecte…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50268-337

What is NDC 50268-337?: 50268-337 is the product NDC for Fluconazole, Fluconazole 100 mg/1 tablet, listed with the FDA by AvPAK. 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?: AvPAK, NDC labeler code 50268. 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?: 160 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
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 150 mg/1	TabletOral	Radha Pharmaceuticals Inc	77771-398	77771-0398-1177771-0398-13
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 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
Fluconazole	Fluconazole 150 mg/1	TabletOral	REMEDYREPACK INC.	70518-4336	70518-4336-00
Fluconazole	Fluconazole 150 mg/1	TabletOral	REMEDYREPACK INC.	70518-4332	70518-4332-00

All 161 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
Product	Strength	Form · route	Labeler	Product NDC
Fluconazole	Fluconazole 150 mg/1	TabletOral	ASCLEMED USA INC.	87063-205
Fluconazole	Fluconazole 200 mg/1	TabletOral	ASCLEMED USA INC.	87063-206
Fluconazole	Fluconazole 150 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-3578
Fluconazole	Fluconazole 150 mg/1	TabletOral	Northwind Health Company, LLC	51655-435
Fluconazole	Fluconazole 200 mg/1	TabletOral	AvPAK	50268-339
Fluconazole	Fluconazole 100 mg/1	TabletOral	REMEDYREPACK INC.	70518-4242
Fluconazole	Fluconazole 100 mg/1	TabletOral	ASCLEMED USA INC.	87063-204
Fluconazole	Fluconazole 50 mg/1	TabletOral	REMEDYREPACK INC.	70518-4723
Fluconazole	Fluconazole 200 mg/1	TabletOral	Proficient Rx LP	82804-146
Fluconazole	Fluconazole 50 mg/1	TabletOral	ASCLEMED USA INC.	87063-203
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 200 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-8526
Fluconazole	Fluconazole 50 mg/1	TabletOral	NorthStar Rx LLC	16714-694
Fluconazole	Fluconazole 200 mg/1	TabletOral	A-S Medication Solutions	50090-6751
Fluconazole	Fluconazole 150 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-7293
Fluconazole	Fluconazole 150 mg/1	TabletOral	Pharmasource Meds, LLC	82982-070
Fluconazole	Fluconazole 150 mg/1	TabletOral	REMEDYREPACK INC.	70518-4336
Fluconazole	Fluconazole 100 mg/1	TabletOral	American Health Packaging	68084-728

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