Telmisartan
- Product NDC
- 53746-293
- 11-digit product format
- 537460293
- Labeler code
- 53746
- Product ID
- 53746-293_77cf7b02-2f68-41ff-be0d-8ad569613822
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Telmisartan
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals of New York LLC
- Application
- ANDA204415
- Marketing category
- ANDA
- Marketing start
- 2016-09-25
- Substance
- TELMISARTAN
- Active strength
- 80 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 | 80 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 |
|---|
| 53746-293-30 | Telmisartan | 30 in 1 BOTTLE | TABLET | 30 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53746-293 | TELMISARTAN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] | 9 | Current NDC, Legacy NDC, 1 package rows | 20230809_bf2dca37-ce9c-40e4-8ad6-b8186aa7fed1.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 |
|---|
| 53746-293-30 | 53746029330 | 30 TABLET in 1 BOTTLE (53746-293-30) | 30 tablet | 2016-09-25 | 0000-00-00 | No | No | Current |