loteprednol etabonate
- Product NDC
- 60219-1367
- 11-digit product format
- 602191367
- Labeler code
- 60219
- Product ID
- 60219-1367_867b7a8d-85c2-4b5c-8391-49d0a69cb97b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- loteprednol etabonate
- Dosage form
- SUSPENSION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Amneal Pharmaceuticals NY LLC
- Application
- ANDA216345
- Marketing category
- ANDA
- Marketing start
- 2024-12-18
- Substance
- LOTEPREDNOL ETABONATE
- Active strength
- 2 mg/mL
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- loteprednol etabonate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LOTEPREDNOL ETABONATE | 2 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | YEH1EZ96K6 |
| Rxcui | 311381 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 60219-1367-6 | loteprednol etabonate | 1 in 1 CARTON | SUSPENSION/ DROPS | 1 | | 5 |
| 60219-1367-6 | loteprednol etabonate | 10 mL in 1 BOTTLE | SUSPENSION/ DROPS | 10 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60219-1367 | LOTEPREDNOL ETABONATE SUSPENSION/ DROPS [AMNEAL PHARMACEUTICALS NY LLC] | 4 | Current NDC, 2 package rows | 20241219_3c2e7083-6ba1-4131-a23f-462b02e5c036.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 |
|---|
| 60219-1367-6 | 60219136706 | 1 BOTTLE in 1 CARTON (60219-1367-6) / 10 mL in 1 BOTTLE | 1 bottle | 2024-12-18 | No | No | Current |