Amlodipine and olmesartan Medoxomil
- Product NDC
- 67877-502
- 11-digit product format
- 678770502
- Labeler code
- 67877
- Product ID
- 67877-502_32238052-6c4c-4b29-a59e-524c819c69f1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amlodipine and olmesartan Medoxomil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Ascend Laboratories, LLC
- Application
- ANDA209042
- Marketing category
- ANDA
- Marketing start
- 2017-08-14
- Substance
- AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
- Active strength
- 10; 40 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 | 10 mg/1 |
| OLMESARTAN MEDOXOMIL | 40 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 864V2Q084H, 6M97XTV3HD |
| Rxcui | 730861, 730866, 730869, 730872 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67877-502-30 | Amlodipine and olmesartan Medoxomil | 30 in 1 BOTTLE | TABLET | 30 | | 10 |
| 67877-502-90 | Amlodipine and olmesartan Medoxomil | 90 in 1 BOTTLE | TABLET | 90 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67877-502 | AMLODIPINE AND OLMESARTAN MEDOXOMIL TABLET [ASCEND LABORATORIES, LLC] | 9 | Current NDC, Legacy NDC, 2 package rows | 20231213_c1204fbe-d086-43cf-bbaa-efec9cd0487c.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 |
|---|
| 67877-502-30 | 67877050230 | 30 TABLET in 1 BOTTLE (67877-502-30) | 30 tablet | 2017-08-14 | 0000-00-00 | No | No | Current |
| 67877-502-90 | 67877050290 | 90 TABLET in 1 BOTTLE (67877-502-90) | 90 tablet | 2017-08-14 | 0000-00-00 | No | No | Current |