Telmisartan
- Product NDC
- 0378-2921
- 11-digit product format
- 003782921
- Labeler code
- 0378
- Product ID
- 0378-2921_0bdc0a35-e9b0-41a9-96f8-5b85497298f9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- telmisartan
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA202397
- Marketing category
- ANDA
- Marketing start
- 2014-07-07
- 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
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 8b67f333-47d1-8464-7ce4-406d3dbb295f | Product name | 7 | 20190618 |
| 796916df-49fa-d043-64a7-fee11194676c | Product name | 9 | 20171130 |
| bded1554-44de-900a-5297-403365d6d4b2 | Product name | 3 | 20170110 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0378-2921-77 | Telmisartan | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | 11 | |
| 0378-2921-93 | Telmisartan | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | 11 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0378-2921-77 | EA - Each | 0378-2921 | 8a9b8e29-5962-4241-8211-333e4188cacd | 1 | 2014-08-01 |
| 0378-2921-93 | EA - Each | 0378-2921 | 68406295-60e9-435d-bc46-276e2e4cc545 | 1 | 2014-08-01 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| TELMISARTAN | ACTIVE INGREDIENT | U5SYW473RQ | TELMISARTAN TABLET [MYLAN PHARMACEUTICALS INC.] | 6 | |
| TELMISARTAN | ACTIVE MOIETY | U5SYW473RQ | TELMISARTAN TABLET [MYLAN PHARMACEUTICALS INC.] | 6 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | TELMISARTAN TABLET [MYLAN PHARMACEUTICALS INC.] | 6 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | TELMISARTAN TABLET [MYLAN PHARMACEUTICALS INC.] | 6 | |
| MEGLUMINE | INACTIVE INGREDIENT | 6HG8UB2MUY | TELMISARTAN TABLET [MYLAN PHARMACEUTICALS INC.] | 6 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | TELMISARTAN TABLET [MYLAN PHARMACEUTICALS INC.] | 6 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | TELMISARTAN TABLET [MYLAN PHARMACEUTICALS INC.] | 6 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 282755 | telmisartan 20 MG Oral Tablet | PSN | c3658bc8-1524-43db-930e-66f9ac01b808 | 11 |
| 205304 | telmisartan 40 MG Oral Tablet | PSN | c3658bc8-1524-43db-930e-66f9ac01b808 | 11 |
| 205305 | telmisartan 80 MG Oral Tablet | PSN | c3658bc8-1524-43db-930e-66f9ac01b808 | 11 |
| 282755 | telmisartan 20 MG Oral Tablet | SCD | c3658bc8-1524-43db-930e-66f9ac01b808 | 11 |
| 205304 | telmisartan 40 MG Oral Tablet | SCD | c3658bc8-1524-43db-930e-66f9ac01b808 | 11 |
| 205305 | telmisartan 80 MG Oral Tablet | SCD | c3658bc8-1524-43db-930e-66f9ac01b808 | 11 |
| 205304 | telmisartan 40 MG Oral Tablet | PSN | eaed12cd-5bfe-4c98-9afc-025ed86a294f | 10 |
| 205304 | telmisartan 40 MG Oral Tablet | SCD | eaed12cd-5bfe-4c98-9afc-025ed86a294f | 10 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0378-2921-77 | 00378292177 | 90 TABLET in 1 BOTTLE, PLASTIC (0378-2921-77) | 90 tablet | 2014-07-07 | 0000-00-00 | No | No | Current |
| 0378-2921-93 | 00378292193 | 30 TABLET in 1 BOTTLE, PLASTIC (0378-2921-93) | 30 tablet | 2014-07-07 | 0000-00-00 | No | No | Current |