Prescription drug · ANDA
Zafirlukast NDC 31722-007
Zafirlukast 10 mg/1 · Tablet, Film coated · Oral · Camber Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-007-01 | 31722000701 | 10 BLISTER PACK in 1 CARTON (31722-007-01) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Sep 10, 2020 | |
| 31722-007-05 | 31722000705 | 500 TABLET, FILM COATED in 1 BOTTLE (31722-007-05)Marketed from Sep 10, 2020 | |
| 31722-007-60 | 31722000760 | 60 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
N431722000701followed by a unit qualifier and the quantityPackage 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.
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.
Related NDCs: other Zafirlukast products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Zafirlukast | Zafirlukast 20 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-292 | 59651-0292-60 |
| Zafirlukast | Zafirlukast 10 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-291 | 59651-0291-60 |
| Zafirlukast | Zafirlukast 20 mg/1 | Tablet, CoatedOral | AvKARE | 42291-971 | 42291-0971-60 |
| Zafirlukast | Zafirlukast 10 mg/1 | Tablet, CoatedOral | AvKARE | 42291-970 | 42291-0970-60 |
| Zafirlukast | Zafirlukast 10 mg/1 | Tablet, CoatedOral | Strides Pharma Science Limited | 64380-187 | 64380-0187-01 |
| Zafirlukast | Zafirlukast 20 mg/1 | Tablet, CoatedOral | Strides Pharma Science Limited | 64380-188 | 64380-0188-01 |
| Zafirlukast | Zafirlukast 20 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2361 | 72162-2361-06 |
| Zafirlukast | Zafirlukast 20 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-008 | 31722-0008-0131722-0008-0531722-0008-60 |
| Zafirlukast | Zafirlukast 20 mg/1 | Tablet, Film coatedOral | American Health Packaging | 68084-059 | 68084-0059-21 |
| Zafirlukast | Zafirlukast 20 mg/1 | Tablet, Film coatedOral | Dr. Reddys Laboratories Limited | 55111-626 | 55111-0626-0155111-0626-0555111-0626-30+2 more |
Other NDCs under ANDA 212475
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Zafirlukast | Zafirlukast 20 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2361 |
| Zafirlukast | Zafirlukast 20 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-008 |