Amlodipine Besylate
- Product NDC
- 65862-101
- 11-digit product format
- 658620101
- Labeler code
- 65862
- Product ID
- 65862-101_7929af8c-f3da-4b86-8388-20bbe247336e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amlodipine Besylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA078021
- Marketing category
- ANDA
- Marketing start
- 2007-07-17
- Substance
- AMLODIPINE BESYLATE
- Active strength
- 2.5 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
- 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 | 2.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 864V2Q084H |
| Rxcui | 197361, 308135, 308136 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65862-101-05 | Amlodipine Besylate | 500 in 1 BOTTLE | TABLET | 500 | | 20 |
| 65862-101-30 | Amlodipine Besylate | 30 in 1 BOTTLE | TABLET | 30 | | 20 |
| 65862-101-90 | Amlodipine Besylate | 90 in 1 BOTTLE | TABLET | 90 | | 20 |
| 65862-101-99 | Amlodipine Besylate | 1000 in 1 BOTTLE | TABLET | 1000 | | 20 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65862-101 | AMLODIPINE BESYLATE TABLET [AUROBINDO PHARMA LIMITED] | 19 | Current NDC, Legacy NDC, 4 package rows | 20240426_b6f298ba-2d7e-4a3c-9edb-8b60aba716d6.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 |
|---|
| 65862-101-05 | 65862010105 | 500 TABLET in 1 BOTTLE (65862-101-05) | 500 tablet | 2007-07-17 | 0000-00-00 | No | No | Current |
| 65862-101-30 | 65862010130 | 30 TABLET in 1 BOTTLE (65862-101-30) | 30 tablet | 2007-07-17 | 0000-00-00 | No | No | Current |
| 65862-101-90 | 65862010190 | 90 TABLET in 1 BOTTLE (65862-101-90) | 90 tablet | 2007-07-17 | 0000-00-00 | No | No | Current |
| 65862-101-91 | 65862010191 | 9000 TABLET in 1 BAG (65862-101-91) | 9000 tablet | 17-JUL-07 | | | | Current |
| 65862-101-99 | 65862010199 | 1000 TABLET in 1 BOTTLE (65862-101-99) | 1000 tablet | 2007-07-17 | 0000-00-00 | No | No | Current |