Ryzumvi
- Product NDC
- 83368-075
- 11-digit product format
- 833680075
- Labeler code
- 83368
- Product ID
- 83368-075_7f954669-af25-4d50-8430-36dcc77fd78f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- phentolamine mesylate
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Oyster Point Pharma, Inc.
- Application
- NDA217064
- Marketing category
- NDA
- Marketing start
- 2024-03-25
- Substance
- PHENTOLAMINE MESYLATE
- Active strength
- 10 mg/mL
- Pharmacologic classes
- Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ryzumvi
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PHENTOLAMINE MESYLATE | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | Y7543E5K9T |
| Rxcui | 2677793, 2677798 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 83368-075-30 | Ryzumvi | 6 in 1 CARTON | SOLUTION/ DROPS | 6 | | 4 |
| 83368-075-30 | Ryzumvi | 5 in 1 POUCH | SOLUTION/ DROPS | 5 | | 4 |
| 83368-075-31 | Ryzumvi | 5 in 1 POUCH | SOLUTION/ DROPS | 5 | | 4 |
| 83368-075-31 | Ryzumvi | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 83368-075 | RYZUMVI (PHENTOLAMINE MESYLATE) SOLUTION/ DROPS [OYSTER POINT PHARMA, INC.] | 4 | Current NDC, 4 package rows | 20241123_96bb1e53-c2cc-4e60-a21a-db0269c371bf.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 83368-075-30 | 83368007530 | 6 POUCH in 1 CARTON (83368-075-30) / 5 VIAL, SINGLE-USE in 1 POUCH / .31 mL in 1 VIAL, SINGLE-USE | 6 pouch | 2024-03-25 | No | No | Historical |
| 83368-075-31 | 83368007531 | 1 POUCH in 1 CARTON (83368-075-31) / 5 VIAL, SINGLE-USE in 1 POUCH / .31 mL in 1 VIAL, SINGLE-USE | 1 pouch | 2024-09-25 | Yes | No | Historical |