Amlodipine Besylate
- Product NDC
- 63187-783
- 11-digit product format
- 631870783
- Labeler code
- 63187
- Product ID
- 63187-783_52c3f53e-0feb-4946-82b6-ad9db9258503
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amlodipine besylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA078925
- Marketing category
- ANDA
- Marketing start
- 2010-10-20
- Substance
- AMLODIPINE BESYLATE
- Active strength
- 2.5 mg/1
- Pharmacologic classes
- Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [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 | 2.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 864V2Q084H |
| Rxcui | 308136 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63187-783-10 | Amlodipine Besylate | 10 in 1 BOTTLE | TABLET | 10 | | 5 |
| 63187-783-30 | Amlodipine Besylate | 30 in 1 BOTTLE | TABLET | 30 | | 5 |
| 63187-783-60 | Amlodipine Besylate | 60 in 1 BOTTLE | TABLET | 60 | | 5 |
| 63187-783-90 | Amlodipine Besylate | 90 in 1 BOTTLE | TABLET | 90 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-783 | AMLODIPINE BESYLATE TABLET [PROFICIENT RX LP] | 5 | Current NDC, Legacy NDC, 4 package rows | 20230617_ced6d26e-8c54-4808-88b6-446344f4acd0.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 |
|---|
| 63187-783-10 | 63187078310 | 10 TABLET in 1 BOTTLE (63187-783-10) | 10 tablet | 2016-11-01 | 0000-00-00 | No | No | Current |
| 63187-783-30 | 63187078330 | 30 TABLET in 1 BOTTLE (63187-783-30) | 30 tablet | 2016-11-01 | 0000-00-00 | No | No | Current |
| 63187-783-60 | 63187078360 | 60 TABLET in 1 BOTTLE (63187-783-60) | 60 tablet | 2016-11-01 | 0000-00-00 | No | No | Current |
| 63187-783-90 | 63187078390 | 90 TABLET in 1 BOTTLE (63187-783-90) | 90 tablet | 2016-11-01 | 0000-00-00 | No | No | Current |