NDC codes

FDA NDC Directory
Product NDC (as listed)10147-1700Labeler and product segments. Claims need a package NDC.
Product NDC at billing width10147-1700Add 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
10147-1700-3101471700031014717000330 CAPSULE in 1 BOTTLE (10147-1700-3)Marketed from Feb 1, 2005

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)
itraconazole
Generic name (nonproprietary)
itraconazole
Active ingredients
Itraconazole — 100 mg/1
Dosage form
Capsule
Route
Oral
Labeler
Patriot PharmaceuticalsNDC labeler code 10147
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 020083
Marketing start
Listing expires
Other FDA classes
Azoles (Chemical structure)Breast Cancer Resistance Protein Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
Identifiers
Product ID 10147-1700_2cca3625-96e8-34cf-e063-6294a90ac975SPL ID 2cca3625-96e8-34cf-e063-6294a90ac975SPL set ID 6242b7ad-eaa0-a524-b6e0-ec33e63407dbRxCUI 311204UNII 304NUG5GF4UPC 0310147170079
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

N410147170003 followed by a unit qualifier and the quantity

Package 10147-1700-03. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Itraconazole Capsules are indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised patients: Blastomycosis, pulmonary and extrapulmonary Histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis, and Aspergillosis, pulmonary and extrapulmonary, in patients who are intolerant of or who are refractory to amphotericin B therapy. Specimens for fungal cultures and other relevant laboratory studies (wet mount, histopathology, serology) should be obtained before therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures a…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 10147-1700

What is NDC 10147-1700?
10147-1700 is the product NDC for itraconazole, Itraconazole 100 mg/1 capsule, listed with the FDA by Patriot Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
itraconazole.
What is the active ingredient?
Itraconazole.
Who is the labeler?
Patriot Pharmaceuticals, NDC labeler code 10147. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for itraconazole?
11 other product NDCs are listed under this name. See all itraconazole 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 itraconazole NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
ItraconazoleItraconazole 100 mg/1CapsuleOralRising Pharma Holdings, Inc.16571-24516571-0245-03
ItraconazoleItraconazole 10 mg/mLSolutionOralCamber Pharmaceuticals, Inc.31722-00631722-0006-31
ItraconazoleItraconazole 100 mg/1CapsuleOralTorrent Pharmaceuticals Limited13668-46313668-0463-0513668-0463-3013668-0463-37+1 more
ItraconazoleItraconazole 100 mg/1CapsuleOralAvPAK50268-45050268-0450-12
ItraconazoleItraconazole 100 mg/1Capsule, Coated pelletsOralNorthStar RxLLC16714-74316714-0743-0116714-0743-02
ItraconazoleItraconazole 100 mg/1Capsule, Coated pelletsOralAscend Laboratories, LLC67877-45467877-0454-0567877-0454-3067877-0454-84+1 more
ItraconazoleItraconazole 100 mg/1CapsuleOralAmerican Health Packaging60687-29960687-0299-25
ItraconazoleItraconazole 100 mg/1CapsuleOralAlembic Pharmaceuticals Limited46708-20446708-0204-0446708-0204-1046708-0204-30+2 more
ItraconazoleItraconazole 100 mg/1CapsuleOralAlembic Pharmaceuticals Inc.62332-20462332-0204-0462332-0204-1062332-0204-30+2 more
ItraconazoleItraconazole 100 mg/1CapsuleOralAmneal Pharmaceuticals LLC65162-63065162-0630-03

All 12 itraconazole NDCs

Other NDCs under NDA 020083

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

FDA NDC Directory listings under NDA 020083
ProductStrengthForm · routeLabelerProduct NDC
SporanoxitraconazoleItraconazole 100 mg/1CapsuleOralJanssen Pharmaceuticals, Inc.50458-290

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