Telmisartan and Hydrochlorothiazide
- Product NDC
- 46708-211
- 11-digit product format
- 467080211
- Labeler code
- 46708
- Product ID
- 46708-211_7c37a82a-77c2-4d49-84ee-ee4f70b4ec93
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Telmisartan and Hydrochlorothiazide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA203010
- Marketing category
- ANDA
- Marketing start
- 2014-03-14
- 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 | U5SYW473RQ, 0J48LPH2TH |
| 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 |
|---|
| 46708-211-10 | Telmisartan and Hydrochlorothiazide | 100 in 1 CARTON | TABLET | 100 | | 3 |
| 46708-211-30 | Telmisartan and Hydrochlorothiazide | 30 in 1 BOTTLE | TABLET | 30 | | 3 |
| 46708-211-91 | Telmisartan and Hydrochlorothiazide | 1000 in 1 BOTTLE | TABLET | 1000 | | 3 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-211 | TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLET [ALEMBIC PHARMACEUTICALS LIMITED] | 3 | Current NDC, Legacy NDC, 3 package rows | 20230204_5b476740-e3f0-4f68-b07c-cd9eb2fa27ca.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 |
|---|
| 46708-211-10 | 46708021110 | 100 TABLET in 1 CARTON (46708-211-10) | 100 tablet | 2014-03-14 | 0000-00-00 | No | No | Current |
| 46708-211-30 | 46708021130 | 30 TABLET in 1 BOTTLE (46708-211-30) | 30 tablet | 2014-03-14 | 0000-00-00 | No | No | Current |
| 46708-211-91 | 46708021191 | 1000 TABLET in 1 BOTTLE (46708-211-91) | 1000 tablet | 2014-03-14 | 0000-00-00 | No | No | Current |