Triamterene and Hydrochlorothiazide
- Product NDC
- 71335-2338
- 11-digit product format
- 713352338
- Labeler code
- 71335
- Product ID
- 71335-2338_f2c5d04a-8589-4083-94aa-cced38008ad6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Triamterene and Hydrochlorothiazide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA216211
- Marketing category
- ANDA
- Marketing start
- 2022-02-23
- Substance
- HYDROCHLOROTHIAZIDE; TRIAMTERENE
- Active strength
- 50; 75 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
- 2027-12-31
- Current FDA listing
- Yes
openFDA Listing Details
- Product ID
- 71335-2338_f2c5d04a-8589-4083-94aa-cced38008ad6
- SPL ID
- f2c5d04a-8589-4083-94aa-cced38008ad6
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Triamterene and Hydrochlorothiazide
- Generic name
- Triamterene and Hydrochlorothiazide
- Dosage form
- TABLET
- Route
- ORAL
- Marketing start
- 2022-02-23
- Marketing category
- ANDA
- Application number
- ANDA216211
- Pharmacologic classes
- Decreased Renal K+ Excretion [PE]; Increased Diuresis [PE]; Potassium-sparing Diuretic [EPC]; Thiazide Diuretic [EPC]; Thiazides [CS]
- Listing expiration
- 2027-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| HYDROCHLOROTHIAZIDE | 50 mg/1 |
| TRIAMTERENE | 75 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | 0J48LPH2TH, WS821Z52LQ |
| Rxcui | 310818 |
| Spl Set Id | f3bc491a-961d-4a38-8a55-c4a03be05b74 |
| Manufacturer Name | Bryant Ranch Prepack |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 71335-2338-1 | 30 TABLET in 1 BOTTLE (71335-2338-1) | 2024-01-30 | No |
| 71335-2338-2 | 15 TABLET in 1 BOTTLE (71335-2338-2) | 2024-01-30 | No |
| 71335-2338-3 | 90 TABLET in 1 BOTTLE (71335-2338-3) | 2024-01-30 | No |
| 71335-2338-4 | 100 TABLET in 1 BOTTLE (71335-2338-4) | 2024-01-30 | No |
| 71335-2338-5 | 7 TABLET in 1 BOTTLE (71335-2338-5) | 2024-01-30 | No |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 0J48LPH2TH | HYDROCHLOROTHIAZIDE | 58-93-5 | HYDROCHLOROTHIAZIDE |
| WS821Z52LQ | TRIAMTERENE | 396-01-0 | TRIAMTERENE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-2338-1 | 71335233801 | 30 TABLET in 1 BOTTLE (71335-2338-1) | 30 tablet | 2024-01-30 | No | No | Historical |
| 71335-2338-2 | 71335233802 | 15 TABLET in 1 BOTTLE (71335-2338-2) | 15 tablet | 2024-01-30 | No | No | Historical |
| 71335-2338-3 | 71335233803 | 90 TABLET in 1 BOTTLE (71335-2338-3) | 90 tablet | 2024-01-30 | No | No | Historical |
| 71335-2338-4 | 71335233804 | 100 TABLET in 1 BOTTLE (71335-2338-4) | 100 tablet | 2024-01-30 | No | No | Historical |
| 71335-2338-5 | 71335233805 | 7 TABLET in 1 BOTTLE (71335-2338-5) | 7 tablet | 2024-01-30 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| ® Tablets | Bryant Ranch Prepack | 2026-05-15 | HUMAN PRESCRIPTION DRUG LABEL | 101 |