Amlodipine besylate
- Product NDC
- 43353-989
- 11-digit product format
- 433530989
- Labeler code
- 43353
- Product ID
- 43353-989_0e9a9053-4baf-4549-864b-4a35c92a7e06
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amlodipine besylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA077955
- Marketing category
- ANDA
- Marketing start
- 2007-11-02
- Substance
- AMLODIPINE BESYLATE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Calcium Channel Antagonists [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 | 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 |
|---|
| 43353-989-30 | Amlodipine besylate | 30 in 1 BOTTLE | TABLET | 30 | | 3 |
| 43353-989-45 | Amlodipine besylate | 45 in 1 BOTTLE | TABLET | 45 | | 3 |
| 43353-989-60 | Amlodipine besylate | 90 in 1 BOTTLE | TABLET | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43353-989 | AMLODIPINE BESYLATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | Current NDC, Legacy NDC, 3 package rows | 20171117_17e6d552-7528-4597-9498-104cb04f32e7.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 |
|---|
| 43353-989-30 | 43353098930 | 30 TABLET in 1 BOTTLE (43353-989-30) | 30 tablet | 2016-12-02 | 0000-00-00 | No | No | Current |
| 43353-989-45 | 43353098945 | 45 TABLET in 1 BOTTLE (43353-989-45) | 45 tablet | 2014-12-29 | 0000-00-00 | No | No | Current |
| 43353-989-60 | 43353098960 | 90 TABLET in 1 BOTTLE (43353-989-60) | 90 tablet | 2014-12-29 | 0000-00-00 | No | No | Current |