Amlodipine Besylate
- Product NDC
- 0615-8429
- 11-digit product format
- 006158429
- Labeler code
- 0615
- Product ID
- 0615-8429_608a3d7a-7d7c-4822-9822-464f0542e505
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amlodipine besylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA078925
- Marketing category
- ANDA
- Marketing start
- 2010-10-20
- Marketing end
- 2026-09-30
- 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
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Amlodipine Besylate
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 |
|---|
| 0615-8429-05 | Amlodipine Besylate | 15 in 1 BLISTER PACK | TABLET | 15 | | 16 |
| 0615-8429-30 | Amlodipine Besylate | 5 in 1 BLISTER PACK | TABLET | 5 | | 16 |
| 0615-8429-30 | Amlodipine Besylate | 6 in 1 BOX, UNIT-DOSE | TABLET | 6 | | 16 |
| 0615-8429-39 | Amlodipine Besylate | 30 in 1 BLISTER PACK | TABLET | 30 | | 16 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0615-8429 | AMLODIPINE BESYLATE TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS] | 13 | Current NDC, Legacy NDC, 4 package rows | 20250119_47f228e9-4a34-4d14-988d-b06af90124b9.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 |
|---|
| 0615-8429-05 | 00615842905 | 15 TABLET in 1 BLISTER PACK (0615-8429-05) | 15 tablet | 2022-07-06 | 2026-09-30 | No | No | Current |
| 0615-8429-30 | 00615842930 | 6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8429-30) > 5 TABLET in 1 BLISTER PACK | 6 blister pack | 2022-07-13 | 0000-00-00 | No | No | Current |
| 0615-8429-39 | 00615842939 | 30 TABLET in 1 BLISTER PACK (0615-8429-39) | 30 tablet | 2022-07-06 | 2026-09-30 | No | No | Current |