AMLODIPINE AND OLMESARTAN MEDOXOMIL
- Product NDC
- 72162-2379
- 11-digit product format
- 721622379
- Labeler code
- 72162
- Product ID
- 72162-2379_e325e45e-7520-4aee-88c4-6ad36ecb37c9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amlodipine and Olmesartan Medoxomil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA207435
- Marketing category
- ANDA
- Marketing start
- 2018-01-01
- Substance
- AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
- Active strength
- 5; 20 mg/1; mg/1
- Pharmacologic classes
- Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], 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 AND OLMESARTAN MEDOXOMIL
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AMLODIPINE BESYLATE | 5 mg/1 |
| OLMESARTAN MEDOXOMIL | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 864V2Q084H, 6M97XTV3HD |
| Rxcui | 730869 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 72162-2379-3 | 72162237903 | 30 TABLET in 1 BOTTLE (72162-2379-3) | 30 tablet | 2024-08-15 | No | No | Historical |
| 72162-2379-9 | 72162237909 | 90 TABLET in 1 BOTTLE (72162-2379-9) | 90 tablet | 2024-08-15 | No | No | Historical |