Prescription drug · ANDA
Mometasone Furoate Monohydrate NDC 59651-402
Mometasone furoate monohydrate 50 ug/1 · Spray, Metered · Nasal · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59651-402-17 | 5965104021759651040217 | 1 BOTTLE, SPRAY in 1 CARTON (59651-402-17) / 120 SPRAY, METERED in 1 BOTTLE, SPRAYMarketed from Mar 18, 2024 |
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)
- Mometasone Furoate Monohydrate
- Generic name (nonproprietary)
- mometasone furoate monohydrate
- Active ingredients
- Mometasone furoate monohydrate — 50 ug/1
- Dosage form
- Spray, Metered
- Route
- Nasal
- Labeler
- Aurobindo Pharma LimitedNDC labeler code 59651
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215878
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 59651-402_b24f80c5-afe2-4821-9185-2dad3cfe277aSPL ID b24f80c5-afe2-4821-9185-2dad3cfe277aSPL set ID b24f80c5-afe2-4821-9185-2dad3cfe277aRxCUI 1797865UNII MTW0WEG809UPC 0359651402177
- Pharmacologic class
- Corticosteroid
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. Nasal products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N459651040217followed by a unit qualifier and the quantityPackage 59651-0402-17. 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)
Mometasone Furoate Monohydrate Nasal Spray is a corticosteroid indicated for: Prophylaxis of Nasal Symptoms of Seasonal Allergic Rhinitis in adult and pediatric patients 12 years of age and older ( 1.1 ) Treatment of Chronic Rhinosinusitis with Nasal Polyps in adult patients 18 years of age and older ( 1.2 ) 1.1 Prophylaxis of Seasonal Allergic Rhinitis Mometasone furoate monohydrate nasal spray is indicated for the prophylaxis of the nasal symptoms of seasonal allergic rhinitis in adult and pediatric patients 12 years and older. 1.2 Treatment of Chronic Rhinosinusitis with Nasal Polyps Mometasone furoate monohydrate nasal spray is indicated for the treatment of chronic rhinosinusitis with n…
Excerpt only. Read the full label for complete information.
About NDC 59651-402
- What is NDC 59651-402?
- 59651-402 is the product NDC for Mometasone Furoate Monohydrate, Mometasone furoate monohydrate 50 ug/1 spray, metered, listed with the FDA by Aurobindo Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Mometasone Furoate Monohydrate.
- What is the active ingredient?
- Mometasone furoate monohydrate.
- Who is the labeler?
- Aurobindo Pharma Limited, NDC labeler code 59651. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Mometasone Furoate Monohydrate?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.