telmisartan
- Product NDC
- 65841-804
- 11-digit product format
- 658410804
- Labeler code
- 65841
- Product ID
- 65841-804_9e0aa50a-1fac-4086-b7b6-811cec3f524b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- telmisartan
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Zydus Lifesciences Limited
- Application
- ANDA203325
- Marketing category
- ANDA
- Marketing start
- 2014-08-27
- 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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| U5SYW473RQ | TELMISARTAN | 144701-48-4 | TELMISARTAN |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 65841-804-01 | 65841080401 | 100 TABLET in 1 BOTTLE (65841-804-01) | 100 tablet | 2014-08-27 | No | No | Historical |
| 65841-804-05 | 65841080405 | 500 TABLET in 1 BOTTLE (65841-804-05) | 500 tablet | 2014-08-27 | No | No | Historical |
| 65841-804-06 | 65841080406 | 30 TABLET in 1 BOTTLE (65841-804-06) | 30 tablet | 2014-08-27 | No | No | Historical |
| 65841-804-10 | 65841080410 | 1000 TABLET in 1 BOTTLE (65841-804-10) | 1000 tablet | 2014-08-27 | No | No | Historical |
| 65841-804-16 | 65841080416 | 90 TABLET in 1 BOTTLE (65841-804-16) | 90 tablet | 2014-08-27 | No | No | Historical |
| 65841-804-78 | 65841080478 | 30 BLISTER PACK in 1 CARTON (65841-804-78) / 1 TABLET in 1 BLISTER PACK (65841-804-30) | 30 blister pack | 2014-08-27 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| TELMISARTAN TABLETS | Zydus Lifesciences Limited | 2024-08-12 | HUMAN PRESCRIPTION DRUG LABEL | 8 |