NDC codes

FDA NDC Directory
Product NDC (as listed)31722-007Labeler and product segments. Claims need a package NDC.
Product NDC at billing width31722-0007Add 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
31722-007-013172200070110 BLISTER PACK in 1 CARTON (31722-007-01) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Sep 10, 2020
31722-007-0531722000705500 TABLET, FILM COATED in 1 BOTTLE (31722-007-05)Marketed from Sep 10, 2020
31722-007-603172200076060 TABLET, FILM COATED in 1 BOTTLE (31722-007-60)Marketed from Sep 10, 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)
Zafirlukast
Generic name (nonproprietary)
zafirlukast
Active ingredients
Zafirlukast — 10 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Camber Pharmaceuticals, Inc.NDC labeler code 31722
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 212475
Marketing start
Listing expires
Other FDA classes
Cytochrome P450 2C9 Inhibitors (Mechanism)Leukotriene Receptor Antagonists (Mechanism)
Identifiers
Product ID 31722-007_5d30ffab-38a1-411d-94ad-0a15c227d882SPL ID 5d30ffab-38a1-411d-94ad-0a15c227d882SPL set ID 5d30ffab-38a1-411d-94ad-0a15c227d882RxCUI 199655, 313758UNII XZ629S5L50UPC 0331722007603, 0331722008600
Pharmacologic class
Leukotriene Receptor Antagonist

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

N431722000701 followed by a unit qualifier and the quantity

Package 31722-0007-01. 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 Zafirlukast is indicated for the prophylaxis and chronic treatment of asthma in adults and children 5 years of age and older.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 31722-007

What is NDC 31722-007?
31722-007 is the product NDC for Zafirlukast, Zafirlukast 10 mg/1 tablet, film coated, listed with the FDA by Camber Pharmaceuticals, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Zafirlukast.
What is the active ingredient?
Zafirlukast.
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 Zafirlukast?
11 other product NDCs are listed under this name. See all Zafirlukast 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 Zafirlukast NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
ZafirlukastZafirlukast 20 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-29259651-0292-60
ZafirlukastZafirlukast 10 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-29159651-0291-60
ZafirlukastZafirlukast 20 mg/1Tablet, CoatedOralAvKARE42291-97142291-0971-60
ZafirlukastZafirlukast 10 mg/1Tablet, CoatedOralAvKARE42291-97042291-0970-60
ZafirlukastZafirlukast 10 mg/1Tablet, CoatedOralStrides Pharma Science Limited64380-18764380-0187-01
ZafirlukastZafirlukast 20 mg/1Tablet, CoatedOralStrides Pharma Science Limited64380-18864380-0188-01
ZafirlukastZafirlukast 20 mg/1Tablet, Film coatedOralBryant Ranch Prepack72162-236172162-2361-06
ZafirlukastZafirlukast 20 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-00831722-0008-0131722-0008-0531722-0008-60
ZafirlukastZafirlukast 20 mg/1Tablet, Film coatedOralAmerican Health Packaging68084-05968084-0059-21
ZafirlukastZafirlukast 20 mg/1Tablet, Film coatedOralDr. Reddys Laboratories Limited55111-62655111-0626-0155111-0626-0555111-0626-30+2 more

All 12 Zafirlukast NDCs

Other NDCs under ANDA 212475

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

FDA NDC Directory listings under ANDA 212475
ProductStrengthForm · routeLabelerProduct NDC
ZafirlukastZafirlukast 20 mg/1Tablet, Film coatedOralBryant Ranch Prepack72162-2361
ZafirlukastZafirlukast 20 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-008

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