What is NDC 57237-003?

57237-003 is the product NDC for Fluconazole, Fluconazole 50 mg/1 tablet, listed with the FDA by Rising Pharma Holdings, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Rising Pharma Holdings, Inc., NDC labeler code 57237. 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 57237-003 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)57237-003Labeler and product segments. Claims need a package NDC.

Product NDC at billing width57237-0003Add 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
57237-003-30	5723700033057237000330	30 TABLET in 1 BOTTLE (57237-003-30)Marketed from Oct 7, 2008

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 — 50 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Rising Pharma Holdings, Inc.NDC labeler code 57237
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077731
Marketing start: Oct 7, 2008
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 57237-003_1018b9ad-7145-49b4-903a-b483797d7c86SPL ID 1018b9ad-7145-49b4-903a-b483797d7c86SPL set ID 2ca7efcd-4a8d-4139-a3eb-930afd18b13fRxCUI 197698, 197699, 197700, 197701UNII 8VZV102JFYUPC 0357237005118
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

N457237000330 followed by a unit qualifier and the quantity

Package 57237-0003-30. 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 Jul 4, 2024.

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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 57237-003

What is NDC 57237-003?: 57237-003 is the product NDC for Fluconazole, Fluconazole 50 mg/1 tablet, listed with the FDA by Rising Pharma Holdings, 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?: Rising Pharma Holdings, Inc., NDC labeler code 57237. 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 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	St. Mary's Medical Park Pharmacy	60760-950
Fluconazole	Fluconazole 200 mg/1	TabletOral	American Health Packaging	68084-735
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 50 mg/1	TabletOral	NorthStar Rx LLC	16714-694
Fluconazole	Fluconazole 150 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-3474
Fluconazole	Fluconazole 50 mg/1	TabletOral	Aurobindo Pharma Limited	65862-058
Fluconazole	Fluconazole 100 mg/1	TabletOral	Aurobindo Pharma Limited	65862-059
Fluconazole	Fluconazole 150 mg/1	TabletOral	Aurobindo Pharma Limited	65862-060
Fluconazole	Fluconazole 200 mg/1	TabletOral	Aurobindo Pharma Limited	65862-061
Fluconazole	Fluconazole 150 mg/1	TabletOral	Redpharm Drug	67296-2274
Fluconazole	Fluconazole 100 mg/1	TabletOral	NuCare Pharmaceuticals, Inc.	68071-3768
Fluconazole	Fluconazole 150 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-3515
Fluconazole	Fluconazole 150 mg/1	TabletOral	Pharmasource Meds, LLC	82982-070
Fluconazole	Fluconazole 50 mg/1	TabletOral	Sportpharm LLC	85766-156
Fluconazole	Fluconazole 100 mg/1	TabletOral	Sportpharm LLC	85766-157
Fluconazole	Fluconazole 200 mg/1	TabletOral	Direct_Rx	72189-516
Fluconazole	Fluconazole 150 mg/1	TabletOral	Sportpharm LLC	85766-158
Fluconazole	Fluconazole 200 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-3547

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