Telmisartan and Hydrochlorothiazide
- Product NDC
- 42291-463
- 11-digit product format
- 422910463
- Labeler code
- 42291
- Product ID
- 42291-463_485d63fa-bf2a-c390-e063-6294a90a03c0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Telmisartan and Hydrochlorothiazide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- AvKARE
- Application
- ANDA202544
- Marketing category
- ANDA
- Marketing start
- 2024-06-18
- 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 |
|---|
| 42291-463-11 | Telmisartan and Hydrochlorothiazide | 10 in 1 BLISTER PACK | TABLET | 10 | | 2 |
| 42291-463-30 | Telmisartan and Hydrochlorothiazide | 3 in 1 BOX | TABLET | 3 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42291-463 | TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLET [AVKARE] | 1 | Current NDC, 2 package rows | 20240620_1b303136-dccd-178b-e063-6394a90a35f8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 42291-463-11 | 42291046311 | 10 in 1 BLISTER PACK | | | | | Historical |
| 42291-463-30 | 42291046330 | 3 BLISTER PACK in 1 BOX (42291-463-30) / 10 TABLET in 1 BLISTER PACK (42291-463-11) | 3 blister pack | 2024-06-18 | No | No | Historical |