Amlodipine Besylate
- Product NDC
- 70518-4629
- 11-digit product format
- 705184629
- Labeler code
- 70518
- Product ID
- 70518-4629_50842400-8827-6293-e063-6294a90a1d83
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amlodipine besylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA078925
- Marketing category
- ANDA
- Marketing start
- 2026-04-24
- Substance
- AMLODIPINE BESYLATE
- Active strength
- 2.5 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 | 2.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 864V2Q084H |
| Rxcui | 308136 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-4629-0 | Amlodipine Besylate | 50 in 1 BOX | TABLET | 50 | | 2 |
| 70518-4629-1 | Amlodipine Besylate | 1 in 1 POUCH | TABLET | 1 | | 2 |
| 70518-4629-2 | Amlodipine Besylate | 30 in 1 BLISTER PACK | TABLET | 30 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4629-0 | 70518462900 | 50 POUCH in 1 BOX (70518-4629-0) / 1 TABLET in 1 POUCH (70518-4629-1) | 50 pouch | 2026-04-24 | No | No | Current |
| 70518-4629-1 | 70518462901 | 1 in 1 POUCH | | | | | Historical |
| 70518-4629-2 | 70518462902 | 30 TABLET in 1 BLISTER PACK (70518-4629-2) | 30 tablet | 2026-04-28 | No | No | Current |