Telmisartan
- Product NDC
- 68462-201
- 11-digit product format
- 684620201
- Labeler code
- 68462
- Product ID
- 68462-201_7e08eda5-be87-4e09-ae4e-880a18aa7a0b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Telmisartan
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- Application
- ANDA090032
- Marketing category
- ANDA
- Marketing start
- 2014-07-07
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Telmisartan
- Listing expiration
- 2027-12-31
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#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| TELMISARTAN | ACTIVE INGREDIENT | U5SYW473RQ | TELMISARTAN TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 3 | |
| TELMISARTAN | ACTIVE MOIETY | U5SYW473RQ | TELMISARTAN TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 3 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | TELMISARTAN TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 3 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | TELMISARTAN TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | TELMISARTAN TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 3 | |
| MEGLUMINE | INACTIVE INGREDIENT | 6HG8UB2MUY | TELMISARTAN TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 3 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | TELMISARTAN TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 3 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | TELMISARTAN TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68462-201 | TELMISARTAN TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 11 | Current NDC, Legacy NDC, 7 package rows | 20240315_c6eb489d-2946-4c14-839f-d4af761ead31.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 |
|---|
| 68462-201-01 | 68462020101 | 100 TABLET in 1 BOTTLE (68462-201-01) | 100 tablet | 2014-07-07 | 0000-00-00 | No | No | Current |
| 68462-201-13 | 68462020113 | 3 BLISTER PACK in 1 CARTON (68462-201-13) / 10 TABLET in 1 BLISTER PACK | 3 blister pack | 2014-07-07 | 0000-00-00 | No | No | Current |
| 68462-201-30 | 68462020130 | 30 TABLET in 1 BOTTLE (68462-201-30) | 30 tablet | 2020-12-14 | 0000-00-00 | No | No | Current |
| 68462-201-78 | 68462020178 | 4 BLISTER PACK in 1 CARTON (68462-201-78) / 10 TABLET in 1 BLISTER PACK | 4 blister pack | 2020-12-14 | 0000-00-00 | No | No | Current |
| 68462-201-90 | 68462020190 | 90 TABLET in 1 BOTTLE (68462-201-90) | 90 tablet | 2024-03-07 | | No | No | Historical |