NDC codes

FDA NDC Directory
Product NDC (as listed)72162-2361Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72162-2361Add 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
72162-2361-67216223610660 TABLET, FILM COATED in 1 BOTTLE (72162-2361-6)Marketed from Jun 28, 2024

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)
Zafirlukast
Generic name (nonproprietary)
zafirlukast
Active ingredients
Zafirlukast — 20 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Bryant Ranch PrepackNDC labeler code 72162
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 72162-2361_50679c31-2161-47a0-a704-13a01760fdbfSPL ID 50679c31-2161-47a0-a704-13a01760fdbfSPL set ID d2256673-fe8b-4fba-a73a-a81e24e47cf8RxCUI 199655UNII XZ629S5L50
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

N472162236106 followed by a unit qualifier and the quantity

Package 72162-2361-06. 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 72162-2361

What is NDC 72162-2361?
72162-2361 is the product NDC for Zafirlukast, Zafirlukast 20 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 1 package NDC, 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?
Bryant Ranch Prepack, NDC labeler code 72162. 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 10 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-29159651-0291-60
ZafirlukastZafirlukast 20 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-29259651-0292-60
ZafirlukastZafirlukast 10 mg/1Tablet, CoatedOralAvKARE42291-97042291-0970-60
ZafirlukastZafirlukast 20 mg/1Tablet, CoatedOralAvKARE42291-97142291-0971-60
ZafirlukastZafirlukast 10 mg/1Tablet, CoatedOralStrides Pharma Science Limited64380-18764380-0187-01
ZafirlukastZafirlukast 20 mg/1Tablet, CoatedOralStrides Pharma Science Limited64380-18864380-0188-01
ZafirlukastZafirlukast 10 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-00731722-0007-0131722-0007-0531722-0007-60
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 10 mg/1Tablet, Film coatedOralDr. Reddys Laboratories Limited55111-62555111-0625-0155111-0625-0555111-0625-30+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 10 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-007
ZafirlukastZafirlukast 20 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-008

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