Prescription drug · NDA
Ryaltris NDC 59467-700
olopatadine hydrochloride and mometasone furoate · Olopatadine hydrochloride 665 ug/1; Mometasone furoate monohydrate 25 ug/1 · Spray, Metered · Nasal · HIKMA SPECIALTY USA INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59467-700-27 | 59467070027 | 12 CARTON in 1 BOX (59467-700-27) / 1 BOTTLE, SPRAY in 1 CARTON / 240 SPRAY, METERED in 1 BOTTLE, SPRAYMarketed from Aug 15, 2022 | |
| 59467-700-84 | 59467070084 | 12 CARTON in 1 BOX (59467-700-84) / 1 BOTTLE, SPRAY in 1 CARTON / 56 SPRAY, METERED in 1 BOTTLE, SPRAYMarketed from Aug 15, 2022 |
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)
- Ryaltris
- Generic name (nonproprietary)
- olopatadine hydrochloride and mometasone furoate
- Active ingredients
- Olopatadine hydrochloride — 665 ug/1Mometasone furoate monohydrate — 25 ug/1
- Dosage form
- Spray, Metered
- Route
- Nasal
- Labeler
- HIKMA SPECIALTY USA INC.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 211746
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)Corticosteroid Hormone Receptor Agonists (Mechanism)Decreased Histamine Release (Physiologic effect)Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 59467-700_84bec5d6-00c3-45a3-ae2b-ec28c8b9a290SPL ID 84bec5d6-00c3-45a3-ae2b-ec28c8b9a290SPL set ID 382eac74-a7ce-4f42-ac0a-b253308f335fRxCUI 2591806, 2591812UNII 2XG66W44KF, MTW0WEG809UPC 0359467700276
- Pharmacologic class
- Corticosteroid; Histamine-1 Receptor Antagonist; Histamine-1 Receptor Inhibitor; Mast Cell Stabilizer
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
N459467070027followed by a unit qualifier and the quantityPackage 59467-0700-27. 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)
RYALTRIS is indicated for the treatment of symptoms of seasonal allergic rhinitis in adult and pediatric patients 12 years of age and older. RYALTRIS is a combination of olopatadine, a histamine-1 (H1)-receptor inhibitor, and mometasone furoate, a corticosteroid, indicated for the treatment of symptoms of seasonal allergic rhinitis in adult and pediatric patients 12 years of age and older. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 211746
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 |
|---|---|---|---|---|
| Ryaltrisolopatadine hydrochloride and mometasone furoate | Olopatadine hydrochloride 665 ug/1; Mometasone furoate monohydrate 25 ug/1 | Spray, MeteredNasal | Glenmark Pharmaceuticals Inc., USA | 68462-659 |