OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE
- Product NDC
- 43547-392
- 11-digit product format
- 435470392
- Labeler code
- 43547
- Product ID
- 43547-392_23c860d3-1b9a-4113-bab4-b803492bf7d7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- olmesartan medoxomil and hydrochlorothiazide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Solco Healthcare US, LLC
- Application
- ANDA207804
- Marketing category
- ANDA
- Marketing start
- 2017-04-24
- Substance
- HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
- Active strength
- 12.5; 40 mg/1; mg/1
- Pharmacologic classes
- Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], 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 and HYDROCHLOROTHIAZIDE
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROCHLOROTHIAZIDE | 12.5 mg/1 |
| OLMESARTAN MEDOXOMIL | 40 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6M97XTV3HD, 0J48LPH2TH |
| Rxcui | 403853, 403854, 403855 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43547-392-03 | OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE | 30 in 1 BOTTLE | TABLET | 30 | | 3 |
| 43547-392-09 | OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE | 90 in 1 BOTTLE | TABLET | 90 | | 3 |
| 43547-392-11 | OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE | 1000 in 1 BOTTLE | TABLET | 1000 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43547-392 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE TABLET [SOLCO HEALTHCARE US, LLC] | 2 | Current NDC, Legacy NDC, 3 package rows | 20210618_bdca31d3-60b1-4659-aef7-56530b4f9039.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 |
|---|
| 43547-392-03 | 43547039203 | 30 TABLET in 1 BOTTLE (43547-392-03) | 30 tablet | 2017-04-24 | 0000-00-00 | No | No | Current |
| 43547-392-09 | 43547039209 | 90 TABLET in 1 BOTTLE (43547-392-09) | 90 tablet | 2017-04-24 | 0000-00-00 | No | No | Current |
| 43547-392-11 | 43547039211 | 1000 TABLET in 1 BOTTLE (43547-392-11) | 1000 tablet | 2017-04-24 | 0000-00-00 | No | No | Current |