triamterene and hydrochlorothiazide
- Product NDC
- 68382-856
- 11-digit product format
- 683820856
- Labeler code
- 68382
- Product ID
- 68382-856_e0a51d55-991a-463a-a382-428f33488d77
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- triamterene and hydrochlorothiazide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals (USA) Inc.
- Application
- ANDA208360
- Marketing category
- ANDA
- Marketing start
- 2018-09-04
- Substance
- HYDROCHLOROTHIAZIDE; TRIAMTERENE
- Active strength
- 25; 37.5 mg/1; mg/1
- Pharmacologic classes
- Decreased Renal K+ Excretion [PE], Increased Diuresis [PE], Increased Diuresis [PE], Potassium-sparing Diuretic [EPC], Thiazide Diuretic [EPC], Thiazides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- triamterene and hydrochlorothiazide
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROCHLOROTHIAZIDE | 25 mg/1 |
| TRIAMTERENE | 37.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0J48LPH2TH, WS821Z52LQ |
| Rxcui | 310812, 310818 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68382-856-01 | triamterene and hydrochlorothiazide | 100 in 1 BOTTLE | TABLET | 100 | | 4 |
| 68382-856-05 | triamterene and hydrochlorothiazide | 500 in 1 BOTTLE | TABLET | 500 | | 4 |
| 68382-856-10 | triamterene and hydrochlorothiazide | 1000 in 1 BOTTLE | TABLET | 1000 | | 4 |
| 68382-856-30 | triamterene and hydrochlorothiazide | 10 in 1 BLISTER PACK | TABLET | 10 | | 4 |
| 68382-856-77 | triamterene and hydrochlorothiazide | 10 in 1 CARTON | TABLET | 10 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68382-856 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] | 4 | Current NDC, Legacy NDC, 5 package rows | 20230831_fa69eeb8-ec82-4be1-8cb7-f64094ed957c.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 |
|---|
| 68382-856-01 | 68382085601 | 100 TABLET in 1 BOTTLE (68382-856-01) | 100 tablet | 2018-09-04 | 0000-00-00 | No | No | Current |
| 68382-856-05 | 68382085605 | 500 TABLET in 1 BOTTLE (68382-856-05) | 500 tablet | 2018-09-04 | 0000-00-00 | No | No | Current |
| 68382-856-10 | 68382085610 | 1000 TABLET in 1 BOTTLE (68382-856-10) | 1000 tablet | 2018-09-04 | 0000-00-00 | No | No | Current |
| 68382-856-30 | 68382085630 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 68382-856-77 | 68382085677 | 10 BLISTER PACK in 1 CARTON (68382-856-77) / 10 TABLET in 1 BLISTER PACK (68382-856-30) | 10 blister pack | 2018-09-04 | 0000-00-00 | No | No | Current |