NDC codes

FDA NDC Directory
Product NDC (as listed)31722-006Labeler and product segments. Claims need a package NDC.
Product NDC at billing width31722-0006Add 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
31722-006-31317220006311 BOTTLE, GLASS in 1 CARTON (31722-006-31) / 150 mL in 1 BOTTLE, GLASSMarketed from Sep 1, 2020

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)
Itraconazole
Generic name (nonproprietary)
itraconazole
Active ingredients
Itraconazole — 10 mg/mL
Dosage form
Solution
Route
Oral
Labeler
Camber Pharmaceuticals, Inc.NDC labeler code 31722
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 212239
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 31722-006_2cd3622f-a50f-ec9c-e063-6294a90a3a30SPL ID 2cd3622f-a50f-ec9c-e063-6294a90a3a30SPL set ID 5af0b33d-bfa6-420b-86f0-067f95b402b2RxCUI 348506UNII 304NUG5GF4UPC 0331722006316
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

N431722000631 followed by a unit qualifier and the quantity

Package 31722-0006-31. 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 oral solution is indicated for the treatment of oropharyngeal and esophageal candidiasis. (See CLINICAL PHARMACOLOGY : Special Populations, WARNINGS , and ADVERSE REACTIONS : Postmarketing Experience for more information.)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 31722-006

What is NDC 31722-006?
31722-006 is the product NDC for Itraconazole, Itraconazole 10 mg/mL solution, listed with the FDA by Camber Pharmaceuticals, Inc.. 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?
Camber Pharmaceuticals, Inc., NDC labeler code 31722. 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 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
ItraconazoleItraconazole 10 mg/mLSolutionOralAmneal Pharmaceuticals LLC65162-08765162-0087-3465162-0087-74

All 12 Itraconazole NDCs

Other NDCs under ANDA 212239

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

FDA NDC Directory listings under ANDA 212239
ProductStrengthForm · routeLabelerProduct NDC
Itraconazole OralitraconazoleItraconazole 10 mg/mLSolutionOralNatco Pharma USA LLC69339-159

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