Amlodipine besylate and Olmesartran medoxomil
- Product NDC
- 46708-215
- 11-digit product format
- 467080215
- Labeler code
- 46708
- Product ID
- 46708-215_cbb564d2-add9-430a-a36b-45147d417138
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amlodipine besylate and Olmesartran medoxomil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA207073
- Marketing category
- ANDA
- Marketing start
- 2017-07-18
- 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 besylate and Olmesartran 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 |
|---|
| 46708-215-30 | Amlodipine besylate and Olmesartran medoxomil | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 3 |
| 46708-215-90 | Amlodipine besylate and Olmesartran medoxomil | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 3 |
| 46708-215-91 | Amlodipine besylate and Olmesartran medoxomil | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-215 | AMLODIPINE BESYLATE AND OLMESARTRAN MEDOXOMIL (AMLODIPINE BESYLATE AND OLMESARTRAN MEDOXOMIL) TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED] | 3 | Current NDC, Legacy NDC, 3 package rows | 20230124_cb2df7f7-fee8-42ba-8936-0788c4fcc0cb.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 46708-215-30 | 46708021530 | 30 TABLET, FILM COATED in 1 BOTTLE (46708-215-30) | 2017-07-18 | 0000-00-00 | No | No | Current |
| 46708-215-90 | 46708021590 | 90 TABLET, FILM COATED in 1 BOTTLE (46708-215-90) | 2017-07-18 | 0000-00-00 | No | No | Current |
| 46708-215-91 | 46708021591 | 1000 TABLET, FILM COATED in 1 BOTTLE (46708-215-91) | 2017-07-18 | 0000-00-00 | No | No | Current |