Telmisartan
- Product NDC
- 65862-868
- 11-digit product format
- 658620868
- Labeler code
- 65862
- Product ID
- 65862-868_eea7e7a7-9c01-4097-8e5c-ab1ad574acc8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Telmisartan
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA206511
- Marketing category
- ANDA
- Marketing start
- 2015-09-03
- 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 |
|---|---|---|---|---|---|---|
| 65862-868-03 | Telmisartan | 3 in 1 CARTON | TABLET | 3 | 14 | |
| 65862-868-10 | Telmisartan | 10 in 1 BLISTER PACK | TABLET | 10 | 14 | |
| 65862-868-30 | Telmisartan | 30 in 1 BOTTLE | TABLET | 30 | 14 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 65862-868-03 | EA - Each | 65862-868 | aefcf886-24fe-45cf-b27f-1b15f5e753c1 | 1 | 2016-06-14 |
| 65862-868-10 | EA - Each | 65862-868 | 967356e0-4786-4c9a-ba06-96e0bddaa5a7 | 1 | 2017-03-06 |
| 65862-868-30 | EA - Each | 65862-868 | 2e2301aa-0183-4300-afbc-b52b79e19e80 | 1 | 2021-09-07 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| TELMISARTAN | ACTIVE INGREDIENT | U5SYW473RQ | TELMISARTAN TABLET [AUROBINDO PHARMA LIMITED] | 1 | |
| TELMISARTAN | ACTIVE MOIETY | U5SYW473RQ | TELMISARTAN TABLET [AUROBINDO PHARMA LIMITED] | 1 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | TELMISARTAN TABLET [AUROBINDO PHARMA LIMITED] | 1 | |
| MEGLUMINE | INACTIVE INGREDIENT | 6HG8UB2MUY | TELMISARTAN TABLET [AUROBINDO PHARMA LIMITED] | 1 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | TELMISARTAN TABLET [AUROBINDO PHARMA LIMITED] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | TELMISARTAN TABLET [AUROBINDO PHARMA LIMITED] | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | TELMISARTAN TABLET [AUROBINDO PHARMA LIMITED] | 1 | |
| SODIUM STEARYL FUMARATE | INACTIVE INGREDIENT | 7CV7WJK4UI | TELMISARTAN TABLET [AUROBINDO PHARMA LIMITED] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 282755 | telmisartan 20 MG Oral Tablet | PSN | fef6532d-438a-435e-a61f-216dd8551339 | 14 |
| 205304 | telmisartan 40 MG Oral Tablet | PSN | fef6532d-438a-435e-a61f-216dd8551339 | 14 |
| 205305 | telmisartan 80 MG Oral Tablet | PSN | fef6532d-438a-435e-a61f-216dd8551339 | 14 |
| 282755 | telmisartan 20 MG Oral Tablet | SCD | fef6532d-438a-435e-a61f-216dd8551339 | 14 |
| 205304 | telmisartan 40 MG Oral Tablet | SCD | fef6532d-438a-435e-a61f-216dd8551339 | 14 |
| 205305 | telmisartan 80 MG Oral Tablet | SCD | fef6532d-438a-435e-a61f-216dd8551339 | 14 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 65862-868-03 | 65862086803 | 3 BLISTER PACK in 1 CARTON (65862-868-03) / 10 TABLET in 1 BLISTER PACK (65862-868-10) | 3 blister pack | 2015-09-03 | 0000-00-00 | No | No | Current |
| 65862-868-10 | 65862086810 | 10 in 1 BLISTER PACK | Historical | |||||
| 65862-868-30 | 65862086830 | 30 TABLET in 1 BOTTLE (65862-868-30) | 30 tablet | 2019-06-03 | 0000-00-00 | No | No | Current |