Amlodipine Besylate
- Product NDC
- 55700-543
- 11-digit product format
- 557000543
- Labeler code
- 55700
- Product ID
- 55700-543_08b8f372-6cc8-4c95-8806-006aa9559e66
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amlodipine besylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Quality Care Products, LLC
- Application
- ANDA078925
- Marketing category
- ANDA
- Marketing start
- 2017-08-11
- Marketing end
- 2026-12-31
- Substance
- AMLODIPINE BESYLATE
- Active strength
- 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
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Amlodipine Besylate
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AMLODIPINE BESYLATE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 864V2Q084H |
| Rxcui | 197361, 308135 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55700-543-30 | Amlodipine Besylate | 30 in 1 BOTTLE | TABLET | 30 | | 11 |
| 55700-543-60 | Amlodipine Besylate | 60 in 1 BOTTLE | TABLET | 60 | | 11 |
| 55700-543-90 | Amlodipine Besylate | 90 in 1 BOTTLE | TABLET | 90 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55700-543 | AMLODIPINE BESYLATE TABLET [QUALITY CARE PRODUCTS, LLC] | 11 | Current NDC, Legacy NDC, 3 package rows | 20241219_6b7c18ef-3a85-4ae3-9135-7ac30a0dde08.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 |
|---|
| 55700-543-30 | 55700054330 | 30 TABLET in 1 BOTTLE (55700-543-30) | 30 tablet | 2018-03-09 | 0000-00-00 | No | No | Current |
| 55700-543-60 | 55700054360 | 60 TABLET in 1 BOTTLE (55700-543-60) | 60 tablet | 2017-08-11 | 0000-00-00 | No | No | Current |
| 55700-543-90 | 55700054390 | 90 TABLET in 1 BOTTLE (55700-543-90) | 90 tablet | 2017-08-18 | 2026-12-31 | No | No | Historical |