Amlodipine Besylate
- Product NDC
- 60687-488
- 11-digit product format
- 606870488
- Labeler code
- 60687
- Product ID
- 60687-488_2251e2e4-cefb-7d15-e063-6394a90a8cb0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amlodipine besylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA078925
- Marketing category
- ANDA
- Marketing start
- 2019-08-21
- 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#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 60687-488-01 | Amlodipine Besylate | 100 in 1 BOX, UNIT-DOSE | TABLET | 100 | | 5 |
| 60687-488-11 | Amlodipine Besylate | 1 in 1 BLISTER PACK | TABLET | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60687-488 | AMLODIPINE BESYLATE TABLET [AMERICAN HEALTH PACKAGING] | 5 | Current NDC, Legacy NDC, 2 package rows | 20240919_44f7e13f-b90f-477b-86cf-21667d90f9a9.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 |
|---|
| 60687-488-01 | 60687048801 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-488-01) / 1 TABLET in 1 BLISTER PACK (60687-488-11) | 100 blister pack | 2019-08-21 | 0000-00-00 | No | No | Current |
| 60687-488-11 | 60687048811 | 1 in 1 BLISTER PACK | | | | | | Historical |