Amlodipine Besylate
- Product NDC
- 68788-9345
- 11-digit product format
- 687889345
- Labeler code
- 68788
- Product ID
- 68788-9345_454ff602-1110-4ac5-bc30-152146166629
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amlodipine besylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals, Inc.
- Application
- ANDA078925
- Marketing category
- ANDA
- Marketing start
- 2015-11-24
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Amlodipine Besylate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AMLODIPINE BESYLATE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 864V2Q084H |
| Rxcui | 197361 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-9345-1 | Amlodipine Besylate | 100 in 1 BOTTLE | TABLET | 100 | | 12 |
| 68788-9345-3 | Amlodipine Besylate | 30 in 1 BOTTLE | TABLET | 30 | | 12 |
| 68788-9345-6 | Amlodipine Besylate | 60 in 1 BOTTLE | TABLET | 60 | | 12 |
| 68788-9345-9 | Amlodipine Besylate | 90 in 1 BOTTLE | TABLET | 90 | | 12 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| AMLODIPINE BESYLATE | ACTIVE INGREDIENT | 864V2Q084H | AMLODIPINE BESYLATE TABLET [PREFERRED PHARMACEUTICALS, INC.] | 1 | |
| AMLODIPINE | ACTIVE MOIETY | 1J444QC288 | AMLODIPINE BESYLATE TABLET [PREFERRED PHARMACEUTICALS, INC.] | 1 | |
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS | INACTIVE INGREDIENT | L11K75P92J | AMLODIPINE BESYLATE TABLET [PREFERRED PHARMACEUTICALS, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | AMLODIPINE BESYLATE TABLET [PREFERRED PHARMACEUTICALS, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | AMLODIPINE BESYLATE TABLET [PREFERRED PHARMACEUTICALS, INC.] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | AMLODIPINE BESYLATE TABLET [PREFERRED PHARMACEUTICALS, INC.] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | AMLODIPINE BESYLATE TABLET [PREFERRED PHARMACEUTICALS, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-9345 | AMLODIPINE BESYLATE TABLET [PREFERRED PHARMACEUTICALS, INC.] | 11 | Current NDC, Legacy NDC, 4 package rows | 20250124_01139e81-a4fa-4e13-acdf-c75c79a1aa9c.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 |
|---|
| 68788-9345-1 | 68788934501 | 100 TABLET in 1 BOTTLE (68788-9345-1) | 100 tablet | 2015-11-24 | 0000-00-00 | No | No | Current |
| 68788-9345-3 | 68788934503 | 30 TABLET in 1 BOTTLE (68788-9345-3) | 30 tablet | 2015-11-24 | 0000-00-00 | No | No | Current |
| 68788-9345-6 | 68788934506 | 60 TABLET in 1 BOTTLE (68788-9345-6) | 60 tablet | 2015-11-24 | 0000-00-00 | No | No | Current |
| 68788-9345-9 | 68788934509 | 90 TABLET in 1 BOTTLE (68788-9345-9) | 90 tablet | 2015-11-24 | 0000-00-00 | No | No | Current |