Amlodipine Besylate
- Product NDC
- 65162-008
- 11-digit product format
- 651620008
- Labeler code
- 65162
- Product ID
- 65162-008_4d860e50-5f2c-4c8e-a18e-737825e41022
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amlodipine Besylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA078477
- Marketing category
- ANDA
- Marketing start
- 2010-06-21
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| AMLODIPINE BESYLATE | ACTIVE INGREDIENT | 864V2Q084H | AMLODIPINE BESYLATE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 24 | |
| AMLODIPINE | ACTIVE MOIETY | 1J444QC288 | AMLODIPINE BESYLATE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 24 | |
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS | INACTIVE INGREDIENT | L11K75P92J | AMLODIPINE BESYLATE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 24 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | AMLODIPINE BESYLATE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 24 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | AMLODIPINE BESYLATE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 24 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | AMLODIPINE BESYLATE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 24 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65162-008 | AMLODIPINE BESYLATE TABLET [AMNEAL PHARMACEUTICALS LLC] | 36 | Legacy NDC | 20241025_3d14c6b5-a70a-477f-b332-fa5b93a6296f.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65162-008-03 | 65162000803 | 30 TABLET in 1 BOTTLE (65162-008-03) | 30 tablet | 2010-06-21 | 0000-00-00 | No | No | Current |
| 65162-008-09 | 65162000809 | 90 TABLET in 1 BOTTLE (65162-008-09) | 90 tablet | 2010-06-21 | 0000-00-00 | No | No | Current |
| 65162-008-10 | 65162000810 | 100 TABLET in 1 BOTTLE (65162-008-10) | 100 tablet | 2010-06-21 | 0000-00-00 | No | No | Current |
| 65162-008-11 | 65162000811 | 1000 TABLET in 1 BOTTLE (65162-008-11) | 1000 tablet | 2010-06-21 | 0000-00-00 | No | No | Current |
| 65162-008-50 | 65162000850 | 500 TABLET in 1 BOTTLE (65162-008-50) | 500 tablet | 2010-06-21 | 0000-00-00 | No | No | Current |