olmesartan medoxomil-hydrochlorothiazide
- Product NDC
- 72205-148
- 11-digit product format
- 722050148
- Labeler code
- 72205
- Product ID
- 72205-148_c8197eea-e990-4c0e-bc2d-f080bac8de17
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- olmesartan medoxomil-hydrochlorothiazide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Novadoz Pharmaceuticals LLC
- Application
- ANDA217398
- Marketing category
- ANDA
- Marketing start
- 2025-09-26
- 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-hydrochlorothiazide
- Listing expiration
- 2026-12-31
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 |
|---|
| 72205-148-30 | olmesartan medoxomil-hydrochlorothiazide | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
| 72205-148-90 | olmesartan medoxomil-hydrochlorothiazide | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 1 |
| 72205-148-99 | olmesartan medoxomil-hydrochlorothiazide | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72205-148-30 | 72205014830 | 30 TABLET, FILM COATED in 1 BOTTLE (72205-148-30) | 2025-09-30 | No | No | Current |
| 72205-148-90 | 72205014890 | 90 TABLET, FILM COATED in 1 BOTTLE (72205-148-90) | 2025-09-30 | No | No | Current |
| 72205-148-99 | 72205014899 | 1000 TABLET, FILM COATED in 1 BOTTLE (72205-148-99) | 2025-09-30 | No | No | Current |