Spironolactone and Hydrochlorothiazide
- Product NDC
- 63629-1071
- 11-digit product format
- 636291071
- Labeler code
- 63629
- Product ID
- 63629-1071_ce6448da-1da3-42c9-b4bb-928ae9b04e14
- 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 |
|---|
| 63629-1071-1 | Spironolactone and Hydrochlorothiazide | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 10 |
| 63629-1071-2 | Spironolactone and Hydrochlorothiazide | 60 in 1 BOTTLE, PLASTIC | TABLET | 60 | | 10 |
| 63629-1071-3 | Spironolactone and Hydrochlorothiazide | 1000 in 1 BOTTLE, PLASTIC | TABLET | 1000 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63629-1071 | SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET [BRYANT RANCH PREPACK] | 10 | Current NDC, Legacy NDC, 3 package rows | 20240822_3c9ceab1-75e9-47b0-a062-33d7d446b88a.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 |
|---|
| 63629-1071-1 | 63629107101 | 30 TABLET in 1 BOTTLE, PLASTIC (63629-1071-1) | 30 tablet | 2020-09-15 | 0000-00-00 | No | No | Current |
| 63629-1071-2 | 63629107102 | 60 TABLET in 1 BOTTLE, PLASTIC (63629-1071-2) | 60 tablet | 2020-09-24 | 0000-00-00 | No | No | Current |
| 63629-1071-3 | 63629107103 | 1000 TABLET in 1 BOTTLE, PLASTIC (63629-1071-3) | 1000 tablet | 2020-09-21 | 0000-00-00 | No | No | Current |