Amlodipine Besylate
- Product NDC
- 51655-586
- 11-digit product format
- 516550586
- Labeler code
- 51655
- Product ID
- 51655-586_494ef4e0-5041-c0ae-e063-6394a90a3081
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amlodipine besylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA078925
- Marketing category
- ANDA
- Marketing start
- 2023-01-03
- Substance
- AMLODIPINE BESYLATE
- Active strength
- 10 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Amlodipine Besylate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AMLODIPINE BESYLATE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 864V2Q084H |
| Rxcui | 308135 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51655-586-52 | Amlodipine Besylate | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51655-586 | AMLODIPINE BESYLATE TABLET [NORTHWIND PHARMACEUTICALS, LLC] | 1 | Current NDC, 1 package rows | 20230407_f32bb322-68d7-a4ca-e053-2995a90aa7b0.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 |
|---|
| 51655-586-52 | 51655058652 | 30 TABLET in 1 BOTTLE, PLASTIC (51655-586-52) | 30 tablet | 2023-01-03 | No | No | Current |