AMLODIPINE BESYLATE
- Product NDC
- 68645-580
- 11-digit product format
- 686450580
- Labeler code
- 68645
- Product ID
- 68645-580_4c219dee-9f8c-6c56-e063-6294a90accf8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- AMLODIPINE BESYLATE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Legacy Pharmaceutical Packaging, LLC
- Application
- ANDA078552
- Marketing category
- ANDA
- Marketing start
- 2011-04-25
- 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
- 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 |
|---|
| 68645-580-54 | AMLODIPINE BESYLATE | 30 in 1 BOTTLE | TABLET | 30 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68645-580 | AMLODIPINE BESYLATE TABLET [LEGACY PHARMACEUTICAL PACKAGING, LLC] | 6 | Current NDC, Legacy NDC, 1 package rows | 20250308_215ef2cb-d5b6-43d5-bbd5-195ec57cde2b.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 |
|---|
| 68645-580-54 | 68645058054 | 30 TABLET in 1 BOTTLE (68645-580-54) | 30 tablet | 2011-04-25 | 0000-00-00 | No | No | Current |