Telmisartan
- Product NDC
- 65162-291
- 11-digit product format
- 651620291
- Labeler code
- 65162
- Product ID
- 65162-291_1a0e1325-40d8-4dde-8655-54f6bd962a4f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Telmisartan
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA204415
- Marketing category
- ANDA
- Marketing start
- 2013-05-31
- Substance
- TELMISARTAN
- Active strength
- 20 mg/1
- Pharmacologic classes
- Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Telmisartan
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TELMISARTAN | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U5SYW473RQ |
| Rxcui | 205304, 205305, 282755 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65162-291-03 | Telmisartan | 30 in 1 BOTTLE | TABLET | 30 | | 9 |
| 65162-291-09 | Telmisartan | 90 in 1 BOTTLE | TABLET | 90 | | 9 |
| 65162-291-50 | Telmisartan | 500 in 1 BOTTLE | TABLET | 500 | | 9 |
| 65162-291-63 | Telmisartan | 3 in 1 CARTON | TABLET | 3 | | 9 |
| 65162-291-63 | Telmisartan | 10 in 1 BLISTER PACK | TABLET | 10 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65162-291 | TELMISARTAN TABLET [AMNEAL PHARMACEUTICALS LLC] | 9 | Current NDC, Legacy NDC, 5 package rows | 20241031_20a60231-64f0-4751-aa81-6c0e64334179.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 |
|---|
| 65162-291-03 | 65162029103 | 30 TABLET in 1 BOTTLE (65162-291-03) | 30 tablet | 2013-05-31 | 0000-00-00 | No | No | Current |
| 65162-291-09 | 65162029109 | 90 TABLET in 1 BOTTLE (65162-291-09) | 90 tablet | 2013-05-31 | 0000-00-00 | No | No | Current |
| 65162-291-50 | 65162029150 | 500 TABLET in 1 BOTTLE (65162-291-50) | 500 tablet | 2013-05-31 | 0000-00-00 | No | No | Current |
| 65162-291-63 | 65162029163 | 3 BLISTER PACK in 1 CARTON (65162-291-63) / 10 TABLET in 1 BLISTER PACK | 3 blister pack | 2013-05-31 | 0000-00-00 | No | No | Current |