Loteprednol Etabonate
- Product NDC
- 62756-232
- 11-digit product format
- 627560232
- Labeler code
- 62756
- Product ID
- 62756-232_5911e66e-1d2c-489b-bae8-415c74fd9d88
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Loteprednol Etabonate
- Dosage form
- SUSPENSION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA212450
- Marketing category
- ANDA
- Marketing start
- 2021-05-01
- Substance
- LOTEPREDNOL ETABONATE
- Active strength
- 5 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 | 5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | YEH1EZ96K6 |
| Rxcui | 311382 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62756-232-55 | Loteprednol Etabonate | 1 in 1 CARTON | SUSPENSION/ DROPS | 1 | | 3 |
| 62756-232-55 | Loteprednol Etabonate | 10 mL in 1 BOTTLE | SUSPENSION/ DROPS | 10 | | 3 |
| 62756-232-56 | Loteprednol Etabonate | 15 mL in 1 BOTTLE | SUSPENSION/ DROPS | 15 | | 3 |
| 62756-232-56 | Loteprednol Etabonate | 1 in 1 CARTON | SUSPENSION/ DROPS | 1 | | 3 |
| 62756-232-90 | Loteprednol Etabonate | 1 in 1 CARTON | SUSPENSION/ DROPS | 1 | | 3 |
| 62756-232-90 | Loteprednol Etabonate | 5 mL in 1 BOTTLE | SUSPENSION/ DROPS | 5 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62756-232 | LOTEPREDNOL ETABONATE SUSPENSION/ DROPS [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 2 | Current NDC, Legacy NDC, 6 package rows | 20210501_36cfd5b8-c892-44e1-aaed-fb32d7aeca7c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 62756-232-55 | 62756023255 | 1 BOTTLE in 1 CARTON (62756-232-55) / 10 mL in 1 BOTTLE | 1 bottle | 2021-05-01 | 0000-00-00 | No | No | Current |
| 62756-232-56 | 62756023256 | 1 BOTTLE in 1 CARTON (62756-232-56) / 15 mL in 1 BOTTLE | 1 bottle | 2021-05-01 | 0000-00-00 | No | No | Current |
| 62756-232-90 | 62756023290 | 1 BOTTLE in 1 CARTON (62756-232-90) / 5 mL in 1 BOTTLE | 1 bottle | 2021-05-01 | 0000-00-00 | No | No | Current |