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NDC 59467-0700-84 Ryaltris 25; 665 ug/1; ug/1 Details
Ryaltris 25; 665 ug/1; ug/1
Ryaltris is a NASAL SPRAY, METERED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by HIKMA SPECIALTY USA INC.. The primary component is MOMETASONE FUROATE MONOHYDRATE; OLOPATADINE HYDROCHLORIDE.
Product Information
| NDC | 59467-0700 |
|---|---|
| Product ID | 59467-700_d6cac74c-1bfc-4745-8a35-27f03686c86c |
| Associated GPIs | |
| GCN Sequence Number | 081937 |
| GCN Sequence Number Description | olopatadine HCl/mometasone SPRAY/PUMP 665-25 MCG NASAL |
| HIC3 | Q7O |
| HIC3 Description | NASAL ANTIHISTAMINE AND ANTI-INFLAM. STEROID COMB. |
| GCN | 49205 |
| HICL Sequence Number | 047115 |
| HICL Sequence Number Description | OLOPATADINE HCL/MOMETASONE FUROATE |
| Brand/Generic | Brand |
| Proprietary Name | Ryaltris |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | olopatadine hydrochloride and mometasone furoate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SPRAY, METERED |
| Route | NASAL |
| Active Ingredient Strength | 25; 665 |
| Active Ingredient Units | ug/1; ug/1 |
| Substance Name | MOMETASONE FUROATE MONOHYDRATE; OLOPATADINE HYDROCHLORIDE |
| Labeler Name | HIKMA SPECIALTY USA INC. |
| Pharmaceutical Class | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Decreased Histamine Release [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Histamine-1 Receptor In |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA211746 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 59467-0700-84 (59467070084)
| NDC Package Code | 59467-700-84 |
|---|---|
| Billing NDC | 59467070084 |
| Package | 12 CARTON in 1 BOX (59467-700-84) / 1 BOTTLE, SPRAY in 1 CARTON / 56 SPRAY, METERED in 1 BOTTLE, SPRAY |
| Marketing Start Date | 2022-08-15 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |