Amlodipine Besylate
- Product NDC
- 43353-684
- 11-digit product format
- 433530684
- Labeler code
- 43353
- Product ID
- 43353-684_1fb58ec3-f97b-443f-ada2-a8d4edaedef8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- amlodipine besylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA078414
- Marketing category
- ANDA
- Marketing start
- 2010-04-07
- Marketing end
- 0000-00-00
- 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
- 2020-12-31
- 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 [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| AMLODIPINE | ACTIVE MOIETY | 1J444QC288 | AMLODIPINE BESYLATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS | INACTIVE INGREDIENT | L11K75P92J | AMLODIPINE BESYLATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | AMLODIPINE BESYLATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | AMLODIPINE BESYLATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | AMLODIPINE BESYLATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43353-684 | AMLODIPINE BESYLATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | Legacy NDC | 20171026_6e83de08-b0f6-492a-a2db-e8d33a7a28aa.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43353-684-15 | 43353068415 | 15 TABLET in 1 BOTTLE, PLASTIC (43353-684-15) | 15 tablet | 2011-06-06 | 0000-00-00 | No | No | Current |
| 43353-684-30 | 43353068430 | 30 TABLET in 1 BOTTLE, PLASTIC (43353-684-30) | 30 tablet | 2011-03-22 | 0000-00-00 | No | No | Current |
| 43353-684-45 | 43353068445 | 45 TABLET in 1 BOTTLE, PLASTIC (43353-684-45) | 45 tablet | 2010-12-15 | 0000-00-00 | No | No | Current |
| 43353-684-60 | 43353068460 | 90 TABLET in 1 BOTTLE, PLASTIC (43353-684-60) | 90 tablet | 2016-07-26 | 0000-00-00 | No | No | Current |