IZERVAY
- Product NDC
- 82829-002
- 11-digit product format
- 828290002
- Labeler code
- 82829
- Product ID
- 82829-002_7fc0afa6-193a-413b-b5be-39c1069b1110
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- avacincaptad pegol
- Dosage form
- INJECTION
- Route
- INTRAVITREAL
- Labeler
- Astellas Pharma US, Inc.
- Application
- NDA217225
- Marketing category
- NDA
- Marketing start
- 2023-08-19
- Substance
- AVACINCAPTAD PEGOL SODIUM
- Active strength
- 20 mg/mL
- Pharmacologic classes
- Complement Inhibitor [EPC], Complement Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- IZERVAY
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AVACINCAPTAD PEGOL SODIUM | 20 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | K86ENL12I5 |
| Rxcui | 2645112, 2645118 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82829-002-01 | IZERVAY | 0.35 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 0.35 | | 9 |
| 82829-002-01 | IZERVAY | 1 in 1 CARTON | INJECTION | 1 | | 9 |
| 82829-002-99 | IZERVAY | 1 in 1 CARTON | INJECTION | 1 | | 9 |
| 82829-002-99 | IZERVAY | 0.35 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 0.35 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82829-002 | IZERVAY (AVACINCAPTAD PEGOL) INJECTION [ASTELLAS PHARMA US, INC.] | 8 | Current NDC, 4 package rows | 20250316_1642fe6a-dc26-4d20-ae6e-654af744e3bd.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 82829-002-01 | 82829000201 | 1 VIAL, SINGLE-DOSE in 1 CARTON (82829-002-01) / .35 mL in 1 VIAL, SINGLE-DOSE | 2023-08-19 | No | No | Current |
| 82829-002-99 | 82829000299 | 1 VIAL, SINGLE-DOSE in 1 CARTON (82829-002-99) / .35 mL in 1 VIAL, SINGLE-DOSE | 2023-08-19 | Yes | No | Current |