Spironolactone and Hydrochlorothiazide
- Product NDC
- 42292-017
- 11-digit product format
- 422920017
- Labeler code
- 42292
- Product ID
- 42292-017_3a8771af-a996-d095-e063-6294a90a5cc2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- spironolactone and hydrochlorothiazide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Mylan Institutional Inc.
- Application
- ANDA086513
- Marketing category
- ANDA
- Marketing start
- 2017-05-12
- 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 |
|---|
| 42292-017-01 | Spironolactone and Hydrochlorothiazide | 1 in 1 BLISTER PACK | TABLET | 1 | | 9 |
| 42292-017-20 | Spironolactone and Hydrochlorothiazide | 100 in 1 CARTON | TABLET | 100 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42292-017 | SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET [MYLAN INSTITUTIONAL INC.] | 8 | Current NDC, Legacy NDC, 2 package rows | 20240619_f2a4fbc0-650b-440d-9555-c1720fe0fe35.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 |
|---|
| 42292-017-01 | 42292001701 | 1 in 1 BLISTER PACK | | | | | | Historical |
| 42292-017-20 | 42292001720 | 100 BLISTER PACK in 1 CARTON (42292-017-20) / 1 TABLET in 1 BLISTER PACK (42292-017-01) | 100 blister pack | 2017-05-12 | 0000-00-00 | No | No | Current |