Ryaltris
- Product NDC
- 59467-700
- 11-digit product format
- 594670700
- Labeler code
- 59467
- Product ID
- 59467-700_84bec5d6-00c3-45a3-ae2b-ec28c8b9a290
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- olopatadine hydrochloride and mometasone furoate
- Dosage form
- SPRAY, METERED
- Route
- NASAL
- Labeler
- HIKMA SPECIALTY USA INC.
- Application
- NDA211746
- Marketing category
- NDA
- Marketing start
- 2022-08-15
- Substance
- MOMETASONE FUROATE MONOHYDRATE; OLOPATADINE HYDROCHLORIDE
- Active strength
- 25; 665 ug/1; ug/1
- Pharmacologic classes
- 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 Inhibitor [EPC], Mast Cell Stabilizer [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ryaltris
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MOMETASONE FUROATE MONOHYDRATE | 25 ug/1 |
| OLOPATADINE HYDROCHLORIDE | 665 ug/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | MTW0WEG809, 2XG66W44KF |
| Rxcui | 2591806, 2591812 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59467-700-27 | Ryaltris | 1 in 1 CARTON | SPRAY, METERED | 1 | | 9 |
| 59467-700-27 | Ryaltris | 12 in 1 BOX | SPRAY, METERED | 12 | | 9 |
| 59467-700-84 | Ryaltris | 12 in 1 BOX | SPRAY, METERED | 12 | | 9 |
| 59467-700-84 | Ryaltris | 1 in 1 CARTON | SPRAY, METERED | 1 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59467-700 | RYALTRIS (OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE) SPRAY, METERED [HIKMA SPECIALTY USA INC.] | 8 | Current NDC, Legacy NDC, 4 package rows | 20240518_382eac74-a7ce-4f42-ac0a-b253308f335f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 59467-700-27 | 59467070027 | 12 CARTON in 1 BOX (59467-700-27) / 1 BOTTLE, SPRAY in 1 CARTON / 240 SPRAY, METERED in 1 BOTTLE, SPRAY | 12 carton | 2022-08-15 | 0000-00-00 | No | No | Current |
| 59467-700-84 | 59467070084 | 12 CARTON in 1 BOX (59467-700-84) / 1 BOTTLE, SPRAY in 1 CARTON / 56 SPRAY, METERED in 1 BOTTLE, SPRAY | 12 carton | 2022-08-15 | 0000-00-00 | No | No | Current |