Amlodipine Besylate
- Product NDC
- 65841-620
- 11-digit product format
- 658410620
- Labeler code
- 65841
- Product ID
- 65841-620_cb1a9e7c-aa86-4596-bc0d-86d8b5750963
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amlodipine Besylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Zydus Lifesciences Limited
- Application
- ANDA078226
- Marketing category
- ANDA
- Marketing start
- 2007-09-21
- 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
- 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 | 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 |
|---|
| 65841-620-01 | Amlodipine Besylate | 100 in 1 BOTTLE | TABLET | 100 | | 13 |
| 65841-620-05 | Amlodipine Besylate | 500 in 1 BOTTLE | TABLET | 500 | | 13 |
| 65841-620-16 | Amlodipine Besylate | 90 in 1 BOTTLE | TABLET | 90 | | 13 |
| 65841-620-77 | Amlodipine Besylate | 10 in 1 CARTON | TABLET | 10 | | 13 |
| 65841-620-77 | Amlodipine Besylate | 10 in 1 BLISTER PACK | TABLET | 10 | | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65841-620 | AMLODIPINE BESYLATE TABLET [ZYDUS LIFESCIENCES LIMITED] | 13 | Current NDC, Legacy NDC, 5 package rows | 20241127_cacb3551-c579-41cb-bed6-4b4d8b0644fc.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 |
|---|
| 65841-620-01 | 65841062001 | 100 TABLET in 1 BOTTLE (65841-620-01) | 100 tablet | 2007-09-21 | 0000-00-00 | No | No | Current |
| 65841-620-05 | 65841062005 | 500 TABLET in 1 BOTTLE (65841-620-05) | 500 tablet | 2007-09-21 | 0000-00-00 | No | No | Current |
| 65841-620-16 | 65841062016 | 90 TABLET in 1 BOTTLE (65841-620-16) | 90 tablet | 2007-09-21 | 0000-00-00 | No | No | Current |
| 65841-620-77 | 65841062077 | 10 BLISTER PACK in 1 CARTON (65841-620-77) / 10 TABLET in 1 BLISTER PACK | 10 blister pack | 2007-09-21 | 0000-00-00 | No | No | Current |