amlodipine besylate
- Product NDC
- 71610-469
- 11-digit product format
- 716100469
- Labeler code
- 71610
- Product ID
- 71610-469_d8b9ec72-8206-48b8-a474-660fc685c17d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- amlodipine besylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- NDA019787
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2019-06-24
- 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
- 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 |
|---|
| 71610-469-30 | amlodipine besylate | 30 in 1 BOTTLE | TABLET | 30 | | 2 |
| 71610-469-45 | amlodipine besylate | 45 in 1 BOTTLE | TABLET | 45 | | 2 |
| 71610-469-53 | amlodipine besylate | 60 in 1 BOTTLE | TABLET | 60 | | 2 |
| 71610-469-60 | amlodipine besylate | 90 in 1 BOTTLE | TABLET | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71610-469 | AMLODIPINE BESYLATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | Current NDC, Legacy NDC, 4 package rows | 20221019_f3482709-c5c3-4bd0-8067-ad57f31bb525.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 |
|---|
| 71610-469-30 | 71610046930 | 30 TABLET in 1 BOTTLE (71610-469-30) | 30 tablet | 2020-09-29 | 0000-00-00 | No | No | Current |
| 71610-469-45 | 71610046945 | 45 TABLET in 1 BOTTLE (71610-469-45) | 45 tablet | 2020-09-29 | 0000-00-00 | No | No | Current |
| 71610-469-53 | 71610046953 | 60 TABLET in 1 BOTTLE (71610-469-53) | 60 tablet | 2022-10-17 | 0000-00-00 | No | No | Current |
| 71610-469-60 | 71610046960 | 90 TABLET in 1 BOTTLE (71610-469-60) | 90 tablet | 2022-10-17 | 0000-00-00 | No | No | Current |