Telmisartan and Hydrochlorothiazide
- Product NDC
- 68462-841
- 11-digit product format
- 684620841
- Labeler code
- 68462
- Product ID
- 68462-841_697f1231-2483-4e0b-9e23-aeb576fa6171
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Telmisartan and Hydrochlorothiazide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- Application
- ANDA202544
- Marketing category
- ANDA
- Marketing start
- 2019-03-04
- Substance
- HYDROCHLOROTHIAZIDE; TELMISARTAN
- Active strength
- 12.5; 80 mg/1; mg/1
- Pharmacologic classes
- Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Telmisartan and Hydrochlorothiazide
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROCHLOROTHIAZIDE | 12.5 mg/1 |
| TELMISARTAN | 80 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U5SYW473RQ, 0J48LPH2TH |
| Rxcui | 283316, 283317, 477130 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68462-841-13 | Telmisartan and Hydrochlorothiazide | 3 in 1 CARTON | TABLET | 3 | | 5 |
| 68462-841-13 | Telmisartan and Hydrochlorothiazide | 10 in 1 BLISTER PACK | TABLET | 10 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68462-841 | TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 4 | Current NDC, Legacy NDC, 2 package rows | 20240312_1e55800d-f77c-4950-a6d7-2055f4c7ea17.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 |
|---|
| 68462-841-13 | 68462084113 | 3 BLISTER PACK in 1 CARTON (68462-841-13) / 10 TABLET in 1 BLISTER PACK | 3 blister pack | 2019-03-04 | 0000-00-00 | No | No | Current |