OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE
- Product NDC
- 33342-174
- 11-digit product format
- 333420174
- Labeler code
- 33342
- Product ID
- 33342-174_79da177b-5eeb-4d95-b949-251b7e8c948b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Macleods Pharmaceuticals Limited
- Application
- ANDA204801
- Marketing category
- ANDA
- Marketing start
- 2023-06-02
- 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
- 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 |
|---|
| 33342-174-07 | OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 2 |
| 33342-174-10 | OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 2 |
| 33342-174-12 | OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE | 10 in 1 CARTON | TABLET, FILM COATED | 10 | | 2 |
| 33342-174-12 | OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 2 |
| 33342-174-44 | OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 33342-174 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] | 1 | Current NDC, 5 package rows | 20230630_03ff0f7e-6aa1-4c38-8c9a-5f1c6a56c747.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 33342-174-07 | 33342017407 | 30 TABLET, FILM COATED in 1 BOTTLE (33342-174-07) | | 2023-06-02 | No | No | Current |
| 33342-174-10 | 33342017410 | 90 TABLET, FILM COATED in 1 BOTTLE (33342-174-10) | | 2023-06-02 | No | No | Current |
| 33342-174-12 | 33342017412 | 10 BLISTER PACK in 1 CARTON (33342-174-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 10 blister pack | 2023-06-02 | No | No | Current |
| 33342-174-44 | 33342017444 | 1000 TABLET, FILM COATED in 1 BOTTLE (33342-174-44) | | 2023-06-02 | No | No | Current |