Amlodipine Besylate
- Product NDC
- 71335-1278
- 11-digit product format
- 713351278
- Labeler code
- 71335
- Product ID
- 71335-1278_19f9229f-2ed5-4d1a-a854-2fe6a1b10cee
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amlodipine besylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA078925
- Marketing category
- ANDA
- Marketing start
- 2010-10-20
- Substance
- AMLODIPINE BESYLATE
- Active strength
- 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 | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 864V2Q084H |
| Rxcui | 197361, 308135 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-1278 | AMLODIPINE BESYLATE TABLET [BRYANT RANCH PREPACK] | 9 | Current NDC, Legacy NDC, 10 package rows | 20240809_1b449c22-0181-4a50-94b3-26139b90b978.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 |
|---|
| 71335-1278-0 | 71335127800 | 5 TABLET in 1 BOTTLE (71335-1278-0) | 5 tablet | 2015-07-23 | 0000-00-00 | No | No | Current |
| 71335-1278-1 | 71335127801 | 30 TABLET in 1 BOTTLE (71335-1278-1) | 30 tablet | 2015-07-23 | 0000-00-00 | No | No | Current |
| 71335-1278-2 | 71335127802 | 90 TABLET in 1 BOTTLE (71335-1278-2) | 90 tablet | 2015-07-23 | 0000-00-00 | No | No | Current |
| 71335-1278-3 | 71335127803 | 60 TABLET in 1 BOTTLE (71335-1278-3) | 60 tablet | 2015-07-23 | 0000-00-00 | No | No | Current |
| 71335-1278-4 | 71335127804 | 100 TABLET in 1 BOTTLE (71335-1278-4) | 100 tablet | 2015-07-23 | 0000-00-00 | No | No | Current |
| 71335-1278-5 | 71335127805 | 180 TABLET in 1 BOTTLE (71335-1278-5) | 180 tablet | 2015-07-23 | 0000-00-00 | No | No | Current |
| 71335-1278-6 | 71335127806 | 120 TABLET in 1 BOTTLE (71335-1278-6) | 120 tablet | 2015-07-23 | 0000-00-00 | No | No | Current |
| 71335-1278-7 | 71335127807 | 10 TABLET in 1 BOTTLE (71335-1278-7) | 10 tablet | 2015-07-23 | 0000-00-00 | No | No | Current |
| 71335-1278-8 | 71335127808 | 500 TABLET in 1 BOTTLE (71335-1278-8) | 500 tablet | 2015-07-23 | 0000-00-00 | No | No | Current |
| 71335-1278-9 | 71335127809 | 1000 TABLET in 1 BOTTLE (71335-1278-9) | 1000 tablet | 2015-07-23 | 0000-00-00 | No | No | Current |