Amlodipine and Olmesartan Medoxomil
- Product NDC
- 68462-569
- 11-digit product format
- 684620569
- Labeler code
- 68462
- Product ID
- 68462-569_6de4a776-9973-4410-ae04-99544813d920
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amlodipine and Olmesartan Medoxomil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- Application
- ANDA207807
- Marketing category
- ANDA
- Marketing start
- 2017-07-05
- 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 | 6M97XTV3HD, 864V2Q084H |
| 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 |
|---|
| 68462-569-14 | Amlodipine and Olmesartan Medoxomil | 10 in 1 CARTON | TABLET, FILM COATED | 10 | | 12 |
| 68462-569-14 | Amlodipine and Olmesartan Medoxomil | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 12 |
| 68462-569-30 | Amlodipine and Olmesartan Medoxomil | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 12 |
| 68462-569-90 | Amlodipine and Olmesartan Medoxomil | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68462-569 | AMLODIPINE AND OLMESARTAN MEDOXOMIL TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] | 12 | Current NDC, Legacy NDC, 4 package rows | 20240104_2edf43fb-0755-4ffb-bc38-75a4e2432588.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 |
|---|
| 68462-569-14 | 68462056914 | 10 BLISTER PACK in 1 CARTON (68462-569-14) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 10 blister pack | 2017-07-05 | 0000-00-00 | No | No | Current |
| 68462-569-30 | 68462056930 | 30 TABLET, FILM COATED in 1 BOTTLE (68462-569-30) | | 2017-07-05 | 0000-00-00 | No | No | Current |
| 68462-569-90 | 68462056990 | 90 TABLET, FILM COATED in 1 BOTTLE (68462-569-90) | | 2017-07-05 | 0000-00-00 | No | No | Current |