AMLODIPINE BESYLATE
- Product NDC
- 68788-8451
- 11-digit product format
- 687888451
- Labeler code
- 68788
- Product ID
- 68788-8451_57f51242-eb35-4bb6-8a3b-3d0f43b1966e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- AMLODIPINE BESYLATE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA078414
- Marketing category
- ANDA
- Marketing start
- 2023-05-30
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- AMLODIPINE BESYLATE
- Brand name suffix
- 10 mg
- Listing expiration
- 2027-12-31
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 |
|---|
| 68788-8451-1 | AMLODIPINE BESYLATE10 mg | 100 in 1 BOTTLE | TABLET | 100 | | 5 |
| 68788-8451-3 | AMLODIPINE BESYLATE10 mg | 30 in 1 BOTTLE | TABLET | 30 | | 5 |
| 68788-8451-6 | AMLODIPINE BESYLATE10 mg | 60 in 1 BOTTLE | TABLET | 60 | | 5 |
| 68788-8451-9 | AMLODIPINE BESYLATE10 mg | 90 in 1 BOTTLE | TABLET | 90 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-8451 | AMLODIPINE BESYLATE 10 MG (AMLODIPINE BESYLATE) TABLET [PREFERRED PHARMACEUTICALS INC.] | 4 | Current NDC, 4 package rows | 20250124_ea9f44a1-96cf-496a-8c07-18d8de27e512.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 |
|---|
| 68788-8451-1 | 68788845101 | 100 TABLET in 1 BOTTLE (68788-8451-1) | 100 tablet | 2023-05-30 | No | No | Historical |
| 68788-8451-3 | 68788845103 | 30 TABLET in 1 BOTTLE (68788-8451-3) | 30 tablet | 2023-05-30 | No | No | Historical |
| 68788-8451-6 | 68788845106 | 60 TABLET in 1 BOTTLE (68788-8451-6) | 60 tablet | 2023-05-30 | No | No | Historical |
| 68788-8451-9 | 68788845109 | 90 TABLET in 1 BOTTLE (68788-8451-9) | 90 tablet | 2023-05-30 | No | No | Historical |