Telmisartan
- Product NDC
- 46708-609
- 11-digit product format
- 467080609
- Labeler code
- 46708
- Product ID
- 46708-609_ae0d2b4e-7cf3-481b-9fc7-002c00214a56
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Telmisartan
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA202130
- Marketing category
- ANDA
- Marketing start
- 2016-06-25
- Substance
- TELMISARTAN
- Active strength
- 40 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 | 40 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 |
|---|
| 46708-609-10 | Telmisartan | 100 in 1 CARTON | TABLET | 100 | | 2 |
| 46708-609-30 | Telmisartan | 30 in 1 BOTTLE | TABLET | 30 | | 2 |
| 46708-609-91 | Telmisartan | 1000 in 1 BOTTLE | TABLET | 1000 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-609 | TELMISARTAN TABLET [ALEMBIC PHARMACEUTICALS LIMITED] | 2 | Current NDC, Legacy NDC, 3 package rows | 20230129_4be6575f-ea8d-4cd8-a49d-3d1c93f2621a.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 |
|---|
| 46708-609-10 | 46708060910 | 100 TABLET in 1 CARTON (46708-609-10) | 100 tablet | 2016-06-25 | 0000-00-00 | No | No | Current |
| 46708-609-30 | 46708060930 | 30 TABLET in 1 BOTTLE (46708-609-30) | 30 tablet | 2016-06-25 | 0000-00-00 | No | No | Current |
| 46708-609-91 | 46708060991 | 1000 TABLET in 1 BOTTLE (46708-609-91) | 1000 tablet | 2016-06-25 | 0000-00-00 | No | No | Current |