AMLODIPINE BESYLATE
- Product NDC
- 82804-971
- 11-digit product format
- 828040971
- Labeler code
- 82804
- Product ID
- 82804-971_6313edc5-d2d5-44a1-a06f-7f7829c870d2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- AMLODIPINE BESYLATE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA078414
- Marketing category
- ANDA
- Marketing start
- 2021-10-01
- Substance
- AMLODIPINE BESYLATE
- Active strength
- 10 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
- Brand name suffix
- 10 mg
- 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 | 197361, 308135, 308136 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82804-971-00 | AMLODIPINE BESYLATE10 mg | 100 in 1 BOTTLE | TABLET | 100 | | 1 |
| 82804-971-11 | AMLODIPINE BESYLATE10 mg | 1000 in 1 BOTTLE | TABLET | 1000 | | 1 |
| 82804-971-30 | AMLODIPINE BESYLATE10 mg | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
| 82804-971-55 | AMLODIPINE BESYLATE10 mg | 500 in 1 BOTTLE | TABLET | 500 | | 1 |
| 82804-971-60 | AMLODIPINE BESYLATE10 mg | 60 in 1 BOTTLE | TABLET | 60 | | 1 |
| 82804-971-72 | AMLODIPINE BESYLATE10 mg | 120 in 1 BOTTLE | TABLET | 120 | | 1 |
| 82804-971-90 | AMLODIPINE BESYLATE10 mg | 90 in 1 BOTTLE | TABLET | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82804-971 | AMLODIPINE BESYLATE 2.5 MG (AMLODIPINE BESYLATE) TABLET AMLODIPINE BESYLATE 5 MG (AMLODIPINE BESYLATE) TABLET AMLODIPINE BESYLATE 10 MG (AMLODIPINE BESYLATE) TABLET [PROFICIENT RX LP] | 1 | Current NDC, 7 package rows | 20250216_6313edc5-d2d5-44a1-a06f-7f7829c870d2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 82804-971-00 | 82804097100 | 100 TABLET in 1 BOTTLE (82804-971-00) | 100 tablet | 2025-02-13 | No | No | Current |
| 82804-971-11 | 82804097111 | 1000 TABLET in 1 BOTTLE (82804-971-11) | 1000 tablet | 2025-02-13 | No | No | Current |
| 82804-971-30 | 82804097130 | 30 TABLET in 1 BOTTLE (82804-971-30) | 30 tablet | 2025-02-13 | No | No | Current |
| 82804-971-55 | 82804097155 | 500 TABLET in 1 BOTTLE (82804-971-55) | 500 tablet | 2025-02-13 | No | No | Current |
| 82804-971-60 | 82804097160 | 60 TABLET in 1 BOTTLE (82804-971-60) | 60 tablet | 2025-02-13 | No | No | Current |
| 82804-971-72 | 82804097172 | 120 TABLET in 1 BOTTLE (82804-971-72) | 120 tablet | 2025-02-13 | No | No | Current |
| 82804-971-90 | 82804097190 | 90 TABLET in 1 BOTTLE (82804-971-90) | 90 tablet | 2025-02-13 | No | No | Current |