NDC codes

FDA NDC Directory
Product NDC (as listed)68071-2557Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68071-2557Add 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
68071-2557-1680712557016807125570112 BLISTER PACK in 1 CARTON (68071-2557-1) / 1 TABLET in 1 BLISTER PACKMarketed from Oct 28, 2021

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
NuCare Pharmaceuticals,Inc.NDC labeler code 68071
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077253
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 68071-2557_2dcc5468-9b13-b6d5-e063-6294a90a4139SPL ID 2dcc5468-9b13-b6d5-e063-6294a90a4139SPL set ID cf6c7cca-d074-2178-e053-2a95a90a3af7RxCUI 197699UNII 8VZV102JFYUPC 0368071255713
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

N468071255701 followed by a unit qualifier and the quantity

Package 68071-2557-01. 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: 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 68071-2557

What is NDC 68071-2557?
68071-2557 is the product NDC for Fluconazole, Fluconazole 150 mg/1 tablet, listed with the FDA by NuCare Pharmaceuticals,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?
NuCare Pharmaceuticals,Inc., NDC labeler code 68071. 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 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
ProductStrengthForm · routeLabelerProduct NDC
FluconazoleFluconazole 150 mg/1TabletOralA-S Medication Solutions50090-5764
FluconazoleFluconazole 100 mg/1TabletOralNorthwind Health Company, LLC51655-889
FluconazoleFluconazole 200 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.55289-824
FluconazoleFluconazole 150 mg/1TabletOralSt. Mary's Medical Park Pharmacy60760-803
FluconazoleFluconazole 200 mg/1TabletOralProficient Rx LP63187-878
FluconazoleFluconazole 50 mg/1TabletOralCoupler LLC67046-1546
FluconazoleFluconazole 100 mg/1TabletOralCoupler LLC67046-2000
FluconazoleFluconazole 50 mg/1TabletOralBluePoint Laboratories68001-251
FluconazoleFluconazole 100 mg/1TabletOralBluePoint Laboratories68001-252
FluconazoleFluconazole 150 mg/1TabletOralBluePoint Laboratories68001-253
FluconazoleFluconazole 200 mg/1TabletOralBluePoint Laboratories68001-254
FluconazoleFluconazole 50 mg/1TabletOralGlenmark Pharmaceuticals Inc., USA68462-101
FluconazoleFluconazole 100 mg/1TabletOralGlenmark Pharmaceuticals Inc., USA68462-102
FluconazoleFluconazole 200 mg/1TabletOralGlenmark Pharmaceuticals Inc., USA68462-104
FluconazoleFluconazole 150 mg/1TabletOralGlenmark Pharmaceuticals Inc., USA68462-119
FluconazoleFluconazole 150 mg/1TabletOralREMEDYREPACK INC.70518-4332
FluconazoleFluconazole 100 mg/1TabletOralREMEDYREPACK INC.70518-4413
FluconazoleFluconazole 150 mg/1TabletOralProficient Rx LP71205-796
FluconazoleFluconazole 150 mg/1TabletOralBryant Ranch Prepack71335-2268
FluconazoleFluconazole 150 mg/1TabletOralDirect Rx72189-342

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