telmisartan
- Product NDC
- 67877-484
- 11-digit product format
- 678770484
- Labeler code
- 67877
- Product ID
- 67877-484_3176efce-402d-3398-e063-6294a90a2f27
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- telmisartan
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Ascend Laboratories, LLC
- Application
- ANDA205150
- Marketing category
- ANDA
- Marketing start
- 2016-06-12
- 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 |
|---|
| 67877-484-05 | telmisartan | 500 in 1 BOTTLE | TABLET | 500 | | 10 |
| 67877-484-30 | telmisartan | 30 in 1 BOTTLE | TABLET | 30 | | 10 |
| 67877-484-90 | telmisartan | 90 in 1 BOTTLE | TABLET | 90 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67877-484 | TELMISARTAN TABLET [ASCEND LABORATORIES, LLC] | 10 | Current NDC, Legacy NDC, 3 package rows | 20250402_29bddc43-2809-4e1f-ae35-2865e15e9bb6.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 |
|---|
| 67877-484-05 | 67877048405 | 500 TABLET in 1 BOTTLE (67877-484-05) | 500 tablet | 2019-07-25 | 0000-00-00 | No | No | Current |
| 67877-484-30 | 67877048430 | 30 TABLET in 1 BOTTLE (67877-484-30) | 30 tablet | 2019-07-25 | 0000-00-00 | No | No | Current |
| 67877-484-84 | 67877048484 | 3 BLISTER PACK in 1 CARTON (67877-484-84) > 10 TABLET in 1 BLISTER PACK | 3 blister pack | 2016-06-12 | 0000-00-00 | No | No | Current |
| 67877-484-90 | 67877048490 | 90 TABLET in 1 BOTTLE (67877-484-90) | 90 tablet | 2019-07-25 | 0000-00-00 | No | No | Current |