NDC codes

FDA NDC Directory
Product NDC (as listed)71335-1268Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-1268Add 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
71335-1268-1713351268011 BLISTER PACK in 1 POUCH (71335-1268-1) / 1 TABLET in 1 BLISTER PACKMarketed from Oct 7, 2008
71335-1268-2713351268022 BLISTER PACK in 1 POUCH (71335-1268-2) / 1 TABLET in 1 BLISTER PACKMarketed from Oct 7, 2008
71335-1268-3713351268033 BLISTER PACK in 1 POUCH (71335-1268-3) / 1 TABLET in 1 BLISTER PACKMarketed from Oct 7, 2008

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
Bryant Ranch PrepackNDC labeler code 71335
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 71335-1268_37401a7b-6d0c-5f6e-e063-6294a90a3e36SPL ID 37401a7b-6d0c-5f6e-e063-6294a90a3e36SPL set ID 90538767-c84b-4637-8ab6-8c147315eafaRxCUI 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

N471335126801 followed by a unit qualifier and the quantity

Package 71335-1268-01. 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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71335-1268

What is NDC 71335-1268?
71335-1268 is the product NDC for Fluconazole, Fluconazole 150 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 3 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?
Bryant Ranch Prepack, NDC labeler code 71335. 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
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 150 mg/1TabletOralRadha Pharmaceuticals Inc77771-39877771-0398-1177771-0398-13
FluconazoleFluconazole 50 mg/1TabletOralRadha Pharmaceuticals Inc77771-39677771-0396-30
FluconazoleFluconazole 100 mg/1TabletOralRadha Pharmaceuticals Inc77771-39777771-0397-0177771-0397-30
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 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
ProductStrengthForm · routeLabelerProduct NDC
FluconazoleFluconazole 150 mg/1TabletOralREMEDYREPACK INC.70518-4336
FluconazoleFluconazole 100 mg/1TabletOralAmerican Health Packaging68084-728
FluconazoleFluconazole 50 mg/1TabletOralRising Pharma Holdings, Inc.57237-003
FluconazoleFluconazole 200 mg/1TabletOralAmerican Health Packaging68084-735
FluconazoleFluconazole 100 mg/1TabletOralRising Pharma Holdings, Inc.57237-004
FluconazoleFluconazole 150 mg/1TabletOralRising Pharma Holdings, Inc.57237-005
FluconazoleFluconazole 200 mg/1TabletOralREMEDYREPACK INC.70518-4020
FluconazoleFluconazole 200 mg/1TabletOralRising Pharma Holdings, Inc.57237-006
FluconazoleFluconazole 200 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-3428
FluconazoleFluconazole 150 mg/1TabletOralA-S Medication Solutions50090-6842
FluconazoleFluconazole 150 mg/1TabletOralA-S Medication Solutions50090-2195
FluconazoleFluconazole 200 mg/1TabletOralBryant Ranch Prepack71335-2235
FluconazoleFluconazole 200 mg/1TabletOralProficient Rx LP82804-030
FluconazoleFluconazole 150 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-3474
FluconazoleFluconazole 150 mg/1TabletOralRedpharm Drug67296-2274
FluconazoleFluconazole 150 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-3515
FluconazoleFluconazole 100 mg/1TabletOralNuCare Pharmaceuticals, Inc.68071-3768
FluconazoleFluconazole 150 mg/1TabletOralAurobindo Pharma Limited65862-060
FluconazoleFluconazole 50 mg/1TabletOralAurobindo Pharma Limited65862-058
FluconazoleFluconazole 100 mg/1TabletOralAurobindo Pharma Limited65862-059

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