olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide
- Product NDC
- 70518-4165
- 11-digit product format
- 705184165
- Labeler code
- 70518
- Product ID
- 70518-4165_47cc41df-209b-9d3e-e063-6394a90a5c91
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA206137
- Marketing category
- ANDA
- Marketing start
- 2024-08-22
- Substance
- AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
- Active strength
- 5; 25; 40 mg/1; 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], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AMLODIPINE BESYLATE | 5 mg/1 |
| HYDROCHLOROTHIAZIDE | 25 mg/1 |
| OLMESARTAN MEDOXOMIL | 40 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 864V2Q084H, 0J48LPH2TH, 6M97XTV3HD |
| Rxcui | 1000001 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-4165-0 | olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-4165 | OLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDE TABLET, FILM COATED [REMEDYREPACK INC.] | 1 | Current NDC, 1 package rows | 20240824_57ffeef7-bfa8-4f92-aadc-23cd00022607.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4165-0 | 70518416500 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4165-0) | 2024-08-22 | No | No | Historical |