CLOBETASOL PROPIONATE
- Product NDC
- 81046-0319
- 11-digit product format
- 810460319
- Labeler code
- 81046
- Product ID
- 81046-0319_32e1b12d-ed8c-33a3-e063-6294a90a3109
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- CLOBETASOL PROPIONATE
- Dosage form
- SUSPENSION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Eyenovia, Inc.
- Application
- NDA218158
- Marketing category
- NDA
- Marketing start
- 2024-03-25
- Substance
- CLOBETASOL PROPIONATE
- Active strength
- .5 mg/mL
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- CLOBETASOL PROPIONATE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CLOBETASOL PROPIONATE | .5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 779619577M |
| Rxcui | 2683740 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 81046-0319-1 | CLOBETASOL PROPIONATE | 1 in 1 CARTON | SUSPENSION/ DROPS | 1 | | 3 |
| 81046-0319-1 | CLOBETASOL PROPIONATE | 3.5 mL in 1 BOTTLE, DROPPER | SUSPENSION/ DROPS | 3.5 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 81046-0319 | CLOBETASOL PROPIONATE SUSPENSION/ DROPS [EYENOVIA, INC.] | 3 | Current NDC, 2 package rows | 20250418_7687c980-7006-4222-80b9-c32773772d3e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 81046-0319-1 | 81046031901 | 1 BOTTLE, DROPPER in 1 CARTON (81046-0319-1) / 3.5 mL in 1 BOTTLE, DROPPER | 2024-03-25 | No | No | Historical |