Bepotastine Besilate Ophthalmic Solution 1.5%
- Product NDC
- 46708-598
- 11-digit product format
- 467080598
- Labeler code
- 46708
- Product ID
- 46708-598_de111d74-c740-47b3-adc7-4b855df2c561
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bepotastine Besilate Ophthalmic Solution 1.5%
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA214588
- Marketing category
- ANDA
- Marketing start
- 2023-04-05
- 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 Ophthalmic Solution 1.5%
- 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 |
|---|
| 46708-598-05 | Bepotastine Besilate Ophthalmic Solution 1.5% | 5 mL in 1 BOTTLE | SOLUTION/ DROPS | 5 | | 1 |
| 46708-598-05 | Bepotastine Besilate Ophthalmic Solution 1.5% | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 1 |
| 46708-598-10 | Bepotastine Besilate Ophthalmic Solution 1.5% | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 1 |
| 46708-598-10 | Bepotastine Besilate Ophthalmic Solution 1.5% | 10 mL in 1 BOTTLE | SOLUTION/ DROPS | 10 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-598 | BEPOTASTINE BESILATE OPHTHALMIC SOLUTION 1.5% SOLUTION/ DROPS [ALEMBIC PHARMACEUTICALS LIMITED] | 1 | Current NDC, 4 package rows | 20230722_de111d74-c740-47b3-adc7-4b855df2c561.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 |
|---|
| 46708-598-05 | 46708059805 | 1 BOTTLE in 1 CARTON (46708-598-05) / 5 mL in 1 BOTTLE | 1 bottle | 2023-07-18 | No | No | Current |
| 46708-598-10 | 46708059810 | 1 BOTTLE in 1 CARTON (46708-598-10) / 10 mL in 1 BOTTLE | 1 bottle | 2023-04-05 | No | No | Current |