Bepotastine Besilate
- Product NDC
- 70069-712
- 11-digit product format
- 700690712
- Labeler code
- 70069
- Product ID
- 70069-712_32be8aa1-ad8e-4840-8d22-49316257cda4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bepotastine Besilate
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- Somerset Therapeutics, LLC
- Application
- ANDA217770
- Marketing category
- ANDA
- Marketing start
- 2024-10-10
- 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 |
|---|
| 70069-712-01 | Bepotastine Besilate | 10 mL in 1 BOTTLE | SOLUTION | 10 | | 4 |
| 70069-712-01 | Bepotastine Besilate | 1 in 1 CARTON | SOLUTION | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70069-712 | BEPOTASTINE BESILATE SOLUTION [SOMERSET THERAPEUTICS, LLC] | 4 | Current NDC, 2 package rows | 20241012_cd6a061d-8ad7-4ad1-b039-1e3aa3435d32.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 |
|---|
| 70069-712-01 | 70069071201 | 1 BOTTLE in 1 CARTON (70069-712-01) / 10 mL in 1 BOTTLE | 1 bottle | 2024-10-10 | No | No | Current |