Amlodipine besylate
- Product NDC
- 76282-508
- 11-digit product format
- 762820508
- Labeler code
- 76282
- Product ID
- 76282-508_17a72ab9-cae7-43c3-9913-fff5e038970b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amlodipine besylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Exelan Pharmaceuticals, Inc.
- Application
- ANDA206367
- Marketing category
- ANDA
- Marketing start
- 2022-03-15
- Substance
- AMLODIPINE BESYLATE
- Active strength
- 5 mg/1
- Pharmacologic classes
- Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Amlodipine besylate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AMLODIPINE BESYLATE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 864V2Q084H |
| Rxcui | 197361, 308135, 308136 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76282-508-05 | Amlodipine besylate | 500 in 1 BOTTLE | TABLET | 500 | | 1 |
| 76282-508-10 | Amlodipine besylate | 1000 in 1 BOTTLE | TABLET | 1000 | | 1 |
| 76282-508-90 | Amlodipine besylate | 90 in 1 BOTTLE | TABLET | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76282-508 | AMLODIPINE BESYLATE TABLET [EXELAN PHARMACEUTICALS, INC.] | 1 | Current NDC, Legacy NDC, 3 package rows | 20220315_1a24433f-4464-4c6d-9456-ed1ce38e8ec4.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 |
|---|
| 76282-508-05 | 76282050805 | 500 TABLET in 1 BOTTLE (76282-508-05) | 500 tablet | 2022-03-15 | 0000-00-00 | No | No | Current |
| 76282-508-10 | 76282050810 | 1000 TABLET in 1 BOTTLE (76282-508-10) | 1000 tablet | 2022-03-15 | 0000-00-00 | No | No | Current |
| 76282-508-90 | 76282050890 | 90 TABLET in 1 BOTTLE (76282-508-90) | 90 tablet | 2022-03-15 | 0000-00-00 | No | No | Current |