Spironolactone and Hydrochlorothiazide
- Product NDC
- 71335-2674
- 11-digit product format
- 713352674
- Labeler code
- 71335
- Product ID
- 71335-2674_806507ad-b1ba-45e7-8e53-c702cbb19594
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Spironolactone and Hydrochlorothiazide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA089534
- Marketing category
- ANDA
- Marketing start
- 1987-07-02
- Substance
- HYDROCHLOROTHIAZIDE; SPIRONOLACTONE
- Active strength
- 25; 25 mg/1; mg/1
- Pharmacologic classes
- Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA], Increased Diuresis [PE], 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
- Spironolactone and Hydrochlorothiazide
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROCHLOROTHIAZIDE | 25 mg/1 |
| SPIRONOLACTONE | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0J48LPH2TH, 27O7W4T232 |
| Rxcui | 198224 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71335-2674-1 | Spironolactone and Hydrochlorothiazide | 100 in 1 BOTTLE | TABLET | 100 | | 100 |
| 71335-2674-2 | Spironolactone and Hydrochlorothiazide | 30 in 1 BOTTLE | TABLET | 30 | | 100 |
| 71335-2674-3 | Spironolactone and Hydrochlorothiazide | 60 in 1 BOTTLE | TABLET | 60 | | 100 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-2674-1 | 71335267401 | 100 TABLET in 1 BOTTLE (71335-2674-1) | 100 tablet | 2025-06-26 | No | No | Historical |
| 71335-2674-2 | 71335267402 | 30 TABLET in 1 BOTTLE (71335-2674-2) | 30 tablet | 2025-06-26 | No | No | Historical |
| 71335-2674-3 | 71335267403 | 60 TABLET in 1 BOTTLE (71335-2674-3) | 60 tablet | 2025-06-26 | No | No | Historical |