ILEVRO
- Product NDC
- 82667-400
- 11-digit product format
- 826670400
- Labeler code
- 82667
- Product ID
- 82667-400_4e6f184f-0de5-acca-e063-6394a90ac321
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- nepafenac
- Dosage form
- SUSPENSION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Harrow Eye, LLC
- Application
- NDA203491
- Marketing category
- NDA
- Marketing start
- 2024-05-01
- Substance
- NEPAFENAC
- Active strength
- 3 mg/mL
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ILEVRO
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NEPAFENAC | 3 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0J9L7J6V8C |
| Rxcui | 1362132, 1365866 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82667-400-03 | ILEVRO | 1 in 1 CARTON | SUSPENSION/ DROPS | 1 | | 5 |
| 82667-400-03 | ILEVRO | 3 mL in 1 BOTTLE, PLASTIC | SUSPENSION/ DROPS | 3 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82667-400 | ILEVRO (NEPAFENAC) SUSPENSION/ DROPS [HARROW EYE, LLC] | 1 | Current NDC, 2 package rows | 20240501_10f411d3-a81e-074a-e063-6294a90ab547.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 82667-400-03 | 82667040003 | 1 BOTTLE, PLASTIC in 1 CARTON (82667-400-03) / 3 mL in 1 BOTTLE, PLASTIC | 2024-05-01 | No | No | Historical |