What is NDC 76420-164?

76420-164 is the product NDC for Fluconazole, Fluconazole 150 mg/1 tablet, listed with the FDA by Asclemed USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Asclemed USA, Inc., NDC labeler code 76420. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Fluconazole NDC 76420-164 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)76420-164Labeler and product segments. Claims need a package NDC.

Product NDC at billing width76420-0164Add 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
76420-164-01	7642001640176420016401	1 TABLET in 1 BLISTER PACK (76420-164-01)Marketed from Mar 4, 2022

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 — 150 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Asclemed USA, Inc.NDC labeler code 76420
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077253
Marketing start: Nov 20, 2020
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 76420-164_d964ddff-cfca-92ad-e053-2995a90a6568SPL ID d964ddff-cfca-92ad-e053-2995a90a6568SPL set ID 56a9de97-bbb9-4210-9ace-f77317d5f33bRxCUI 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

N476420016401 followed by a unit qualifier and the quantity

Package 76420-0164-01. 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 Mar 4, 2022.

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 no…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 76420-164

What is NDC 76420-164?: 76420-164 is the product NDC for Fluconazole, Fluconazole 150 mg/1 tablet, listed with the FDA by Asclemed USA, Inc.. 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?: Asclemed USA, Inc., NDC labeler code 76420. 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
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

All 163 Fluconazole NDCs

Other NDCs under ANDA 077253

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

FDA NDC Directory listings under ANDA 077253
Product	Strength	Form · route	Labeler	Product NDC
Fluconazole	Fluconazole 100 mg/1	TabletOral	Radha Pharmaceuticals Inc	77771-397
Fluconazole	Fluconazole 50 mg/1	TabletOral	Radha Pharmaceuticals Inc	77771-396
Fluconazole	Fluconazole 100 mg/1	TabletOral	Northwind Health Company, LLC	51655-889
Fluconazole	Fluconazole 150 mg/1	TabletOral	Bryant Ranch Prepack	71335-2268
Fluconazole	Fluconazole 150 mg/1	TabletOral	Proficient Rx LP	71205-796
Fluconazole	Fluconazole 100 mg/1	TabletOral	Coupler LLC	67046-2000
Fluconazole	Fluconazole 200 mg/1	TabletOral	Coupler LLC	67046-2044
Fluconazole	Fluconazole 150 mg/1	TabletOral	Direct Rx	72189-342
Fluconazole	Fluconazole 200 mg/1	TabletOral	Glenmark Pharmaceuticals Inc., USA	68462-104
Fluconazole	Fluconazole 50 mg/1	TabletOral	Glenmark Pharmaceuticals Inc., USA	68462-101
Fluconazole	Fluconazole 100 mg/1	TabletOral	Glenmark Pharmaceuticals Inc., USA	68462-102
Fluconazole	Fluconazole 100 mg/1	TabletOral	Coupler LLC	67046-0623
Fluconazole	Fluconazole 50 mg/1	TabletOral	Coupler LLC	67046-1546
Fluconazole	Fluconazole 150 mg/1	TabletOral	Glenmark Pharmaceuticals Inc., USA	68462-119
Fluconazole	Fluconazole 150 mg/1	TabletOral	St. Mary's Medical Park Pharmacy	60760-803
Fluconazole	Fluconazole 150 mg/1	TabletOral	Radha Pharmaceuticals Inc	77771-398
Fluconazole	Fluconazole 200 mg/1	TabletOral	Radha Pharmaceuticals Inc	77771-399
Fluconazole	Fluconazole 150 mg/1	TabletOral	REMEDYREPACK INC.	70518-4332
Fluconazole	Fluconazole 150 mg/1	TabletOral	A-S Medication Solutions	50090-5764
Fluconazole	Fluconazole 150 mg/1	TabletOral	Northwind Health Company, LLC	82868-033

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