Bepotastine Besilate
- Product NDC
- 82260-630
- 11-digit product format
- 822600630
- Labeler code
- 82260
- Product ID
- 82260-630_202287f2-01bc-1d43-e063-6294a90a8da1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- bepotastine besilate
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Bausch & Lomb Americas Inc.
- Application
- NDA022288
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2021-05-28
- Substance
- BEPOTASTINE BESYLATE
- Active strength
- 15 mg/mL
- Pharmacologic classes
- Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Bepotastine Besilate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BEPOTASTINE BESYLATE | 15 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6W18MO1QR3 |
| Rxcui | 863038 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82260-630-05 | Bepotastine Besilate | 5 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 5 | | 4 |
| 82260-630-05 | Bepotastine Besilate | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 4 |
| 82260-630-10 | Bepotastine Besilate | 10 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 10 | | 4 |
| 82260-630-10 | Bepotastine Besilate | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82260-630 | BEPOTASTINE BESILATE SOLUTION/ DROPS [BAUSCH & LOMB AMERICAS INC.] | 4 | Current NDC, Legacy NDC, 4 package rows | 20240822_70430ab5-cd0a-451e-acab-347a2f981898.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 82260-630-05 | 82260063005 | 1 BOTTLE, DROPPER in 1 CARTON (82260-630-05) / 5 mL in 1 BOTTLE, DROPPER | 2021-05-28 | 0000-00-00 | No | No | Current |
| 82260-630-10 | 82260063010 | 1 BOTTLE, DROPPER in 1 CARTON (82260-630-10) / 10 mL in 1 BOTTLE, DROPPER | 2021-05-28 | 0000-00-00 | No | No | Current |