telmisartan and hydrochlorothiazide
- Product NDC
- 70756-317
- 11-digit product format
- 707560317
- Labeler code
- 70756
- Product ID
- 70756-317_70efda7e-0c71-4faf-be4e-ef281d7cc297
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- telmisartan and hydrochlorothiazide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Lifestar Pharma LLC
- Application
- ANDA218406
- Marketing category
- ANDA
- Marketing start
- 2025-12-25
- Substance
- HYDROCHLOROTHIAZIDE; TELMISARTAN
- Active strength
- 25; 80 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
- telmisartan and hydrochlorothiazide
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROCHLOROTHIAZIDE | 25 mg/1 |
| TELMISARTAN | 80 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0J48LPH2TH, U5SYW473RQ |
| Rxcui | 283316, 283317, 477130 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70756-317-30 | telmisartan and hydrochlorothiazide | 30 in 1 BOTTLE | TABLET | 30 | | 4 |
| 70756-317-31 | telmisartan and hydrochlorothiazide | 3 in 1 CARTON | TABLET | 3 | | 4 |
| 70756-317-31 | telmisartan and hydrochlorothiazide | 10 in 1 BLISTER PACK | TABLET | 10 | | 4 |
| 70756-317-99 | telmisartan and hydrochlorothiazide | 10 in 1 BLISTER PACK | TABLET | 10 | | 4 |
| 70756-317-99 | telmisartan and hydrochlorothiazide | 10 in 1 CARTON | TABLET | 10 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70756-317 | TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLET [LIFESTAR PHARMA LLC] | 3 | Current NDC, 5 package rows | 20250325_0c1bd0f4-034e-486c-ae46-2855c8c9ebda.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 |
|---|
| 70756-317-30 | 70756031730 | 30 TABLET in 1 BOTTLE (70756-317-30) | 30 tablet | 2025-12-25 | No | No | Current |
| 70756-317-31 | 70756031731 | 3 BLISTER PACK in 1 CARTON (70756-317-31) / 10 TABLET in 1 BLISTER PACK | 3 blister pack | 2025-12-25 | No | No | Current |
| 70756-317-99 | 70756031799 | 10 BLISTER PACK in 1 CARTON (70756-317-99) / 10 TABLET in 1 BLISTER PACK | 10 blister pack | 2025-12-25 | No | No | Current |