TELMISARTAN AND HYDROCHLOROTHIAZIDE
- Product NDC
- 43547-441
- 11-digit product format
- 435470441
- Labeler code
- 43547
- Product ID
- 43547-441_a7294951-f71f-442b-9f8e-2551963db085
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- telmisartan and hydrochlorothiazide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Solco Healthcare LLC
- Application
- ANDA209028
- Marketing category
- ANDA
- Marketing start
- 2018-02-05
- Substance
- HYDROCHLOROTHIAZIDE; TELMISARTAN
- 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
- TELMISARTAN AND HYDROCHLOROTHIAZIDE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROCHLOROTHIAZIDE | 12.5 mg/1 |
| TELMISARTAN | 40 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0J48LPH2TH, U5SYW473RQ |
| Rxcui | 283316, 283317, 477130 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43547-441-03 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 30 in 1 BOTTLE | TABLET | 30 | | 6 |
| 43547-441-09 | TELMISARTAN AND HYDROCHLOROTHIAZIDE | 90 in 1 BOTTLE | TABLET | 90 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43547-441 | TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLET [SOLCO HEALTHCARE LLC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20230922_47c8eee0-f0b7-4bd8-97e9-0029aa1b37db.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 |
|---|
| 43547-441-03 | 43547044103 | 30 TABLET in 1 BOTTLE (43547-441-03) | 30 tablet | 2018-02-05 | 0000-00-00 | No | No | Current |
| 43547-441-09 | 43547044109 | 90 TABLET in 1 BOTTLE (43547-441-09) | 90 tablet | 2018-02-05 | 0000-00-00 | No | No | Current |