AMLODIPINE BESYLATE
- Product NDC
- 68071-3453
- 11-digit product format
- 680713453
- Labeler code
- 68071
- Product ID
- 68071-3453_1492b8f5-b3d0-9497-e063-6394a90a008e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- AMLODIPINE BESYLATE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- 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 | 308135 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-3453-2 | AMLODIPINE BESYLATE10 mg | 120 in 1 BOTTLE | TABLET | 120 | | 3 |
| 68071-3453-3 | AMLODIPINE BESYLATE10 mg | 30 in 1 BOTTLE | TABLET | 30 | | 3 |
| 68071-3453-9 | AMLODIPINE BESYLATE10 mg | 90 in 1 BOTTLE | TABLET | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-3453 | AMLODIPINE BESYLATE 10 MG (AMLODIPINE BESYLATE) TABLET [NUCARE PHARMACEUTICALS,INC.] | 3 | Current NDC, 3 package rows | 20240328_ffe96aa1-db66-33e4-e053-6394a90a7e4e.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 |
|---|
| 68071-3453-2 | 68071345302 | 120 TABLET in 1 BOTTLE (68071-3453-2) | 120 tablet | 2023-07-07 | No | No | Historical |
| 68071-3453-3 | 68071345303 | 30 TABLET in 1 BOTTLE (68071-3453-3) | 30 tablet | 2023-07-07 | No | No | Historical |
| 68071-3453-9 | 68071345309 | 90 TABLET in 1 BOTTLE (68071-3453-9) | 90 tablet | 2023-07-07 | No | No | Historical |