Bepotastine Besilate
- Product NDC
- 0378-7055
- 11-digit product format
- 003787055
- Labeler code
- 0378
- Product ID
- 0378-7055_c8ce95fa-e800-433e-8d40-70a6b1e06140
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bepotastine Besilate
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA206220
- Marketing category
- ANDA
- Marketing start
- 2021-05-28
- Substance
- BEPOTASTINE BESILATE
- 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 BESILATE | 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 |
|---|
| 0378-7055-35 | Bepotastine Besilate | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 4 |
| 0378-7055-35 | Bepotastine Besilate | 5 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 5 | | 4 |
| 0378-7055-67 | Bepotastine Besilate | 10 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 10 | | 4 |
| 0378-7055-67 | 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 |
|---|
| 0378-7055 | BEPOTASTINE BESILATE SOLUTION/ DROPS [MYLAN PHARMACEUTICALS INC.] | 2 | Current NDC, Legacy NDC, 4 package rows | 20210529_75178670-aa57-45f9-94d5-efcf8305e683.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 |
|---|
| 0378-7055-35 | 00378705535 | 1 BOTTLE, DROPPER in 1 CARTON (0378-7055-35) / 5 mL in 1 BOTTLE, DROPPER | 2021-05-28 | 0000-00-00 | No | No | Current |
| 0378-7055-67 | 00378705567 | 1 BOTTLE, DROPPER in 1 CARTON (0378-7055-67) / 10 mL in 1 BOTTLE, DROPPER | 2021-05-28 | 0000-00-00 | No | No | Current |