OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
- Product NDC
- 67877-452
- 11-digit product format
- 678770452
- Labeler code
- 67877
- Product ID
- 67877-452_e6461d60-f7cc-454e-b54e-2bcbcb64e631
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Ascend Laboratories, LLC
- Application
- ANDA207037
- Marketing category
- ANDA
- Marketing start
- 2025-05-01
- 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
- 2026-12-31
- 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 | 0J48LPH2TH, 6M97XTV3HD |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67877-452-30 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 5 |
| 67877-452-90 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67877-452 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [ASCEND LABORATORIES, LLC] | 5 | Current NDC, 2 package rows | 20250501_798fee33-51ad-45d0-82f3-09289304139f.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 67877-452-30 | 67877045230 | 30 TABLET, FILM COATED in 1 BOTTLE (67877-452-30) | 2025-05-01 | No | No | Historical |
| 67877-452-90 | 67877045290 | 90 TABLET, FILM COATED in 1 BOTTLE (67877-452-90) | 2025-05-01 | No | No | Historical |