Telmisartan and Hydrochlorothiazide
- Product NDC
- 68180-193
- 11-digit product format
- 681800193
- Labeler code
- 68180
- Product ID
- 68180-193_92888a3c-daab-4cd1-b883-6ecbe682faa9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Telmisartan and Hydrochlorothiazide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals, Inc.
- Application
- ANDA091351
- Marketing category
- ANDA
- Marketing start
- 2014-08-07
- Substance
- HYDROCHLOROTHIAZIDE; TELMISARTAN
- Active strength
- 12.5; 40 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 | 40 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 |
|---|
| 68180-193-06 | Telmisartan and Hydrochlorothiazide | 30 in 1 BOTTLE | TABLET | 30 | | 15 |
| 68180-193-09 | Telmisartan and Hydrochlorothiazide | 90 in 1 BOTTLE | TABLET | 90 | | 15 |
| 68180-193-11 | Telmisartan and Hydrochlorothiazide | 10 in 1 BLISTER PACK | TABLET | 10 | | 15 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| HYDROCHLOROTHIAZIDE | ACTIVE INGREDIENT | 0J48LPH2TH | TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLET [LUPIN PHARMACEUTICALS, INC.] | 4 | |
| TELMISARTAN | ACTIVE INGREDIENT | U5SYW473RQ | TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLET [LUPIN PHARMACEUTICALS, INC.] | 4 | |
| HYDROCHLOROTHIAZIDE | ACTIVE MOIETY | 0J48LPH2TH | TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLET [LUPIN PHARMACEUTICALS, INC.] | 4 | |
| TELMISARTAN | ACTIVE MOIETY | U5SYW473RQ | TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLET [LUPIN PHARMACEUTICALS, INC.] | 4 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLET [LUPIN PHARMACEUTICALS, INC.] | 4 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLET [LUPIN PHARMACEUTICALS, INC.] | 4 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLET [LUPIN PHARMACEUTICALS, INC.] | 4 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLET [LUPIN PHARMACEUTICALS, INC.] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLET [LUPIN PHARMACEUTICALS, INC.] | 4 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLET [LUPIN PHARMACEUTICALS, INC.] | 4 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLET [LUPIN PHARMACEUTICALS, INC.] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68180-193 | TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLET [LUPIN PHARMACEUTICALS, INC.] | 14 | Current NDC, Legacy NDC, 3 package rows | 20240120_b88054b3-fafa-4b4e-acf5-5294e5555720.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 |
|---|
| 68180-193-06 | 68180019306 | 30 TABLET in 1 BOTTLE (68180-193-06) | 30 tablet | 2015-04-28 | 0000-00-00 | No | No | Current |
| 68180-193-09 | 68180019309 | 90 TABLET in 1 BOTTLE (68180-193-09) | 90 tablet | 2014-08-07 | 0000-00-00 | No | No | Current |
| 68180-193-11 | 68180019311 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 68180-193-13 | 68180019313 | 3 BLISTER PACK in 1 CARTON (68180-193-13) > 10 TABLET in 1 BLISTER PACK (68180-193-11) | 3 blister pack | 2014-08-07 | 0000-00-00 | No | No | Current |