Spironolactone and Hydrochlorothiazide
- Product NDC
- 53489-144
- 11-digit product format
- 534890144
- Labeler code
- 53489
- Product ID
- 53489-144_b1902b0c-42e6-4e08-bb4a-959280f33579
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Spironolactone and Hydrochlorothiazide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- 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 |
|---|
| 53489-144-01 | Spironolactone and Hydrochlorothiazide | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | | 15 |
| 53489-144-05 | Spironolactone and Hydrochlorothiazide | 500 in 1 BOTTLE, PLASTIC | TABLET | 500 | | 15 |
| 53489-144-10 | Spironolactone and Hydrochlorothiazide | 1000 in 1 BOTTLE, PLASTIC | TABLET | 1000 | | 15 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Hydrochlorothiazide | ACTIVE INGREDIENT | 0J48LPH2TH | SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] | 8 | |
| Spironolactone | ACTIVE INGREDIENT | 27O7W4T232 | SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] | 8 | |
| Hydrochlorothiazide | ACTIVE MOIETY | 0J48LPH2TH | SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] | 8 | |
| Spironolactone | ACTIVE MOIETY | 27O7W4T232 | SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] | 8 | |
| Aluminum Oxide | INACTIVE INGREDIENT | LMI26O6933 | SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] | 8 | |
| anhydrous lactose | INACTIVE INGREDIENT | 3SY5LH9PMK | SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] | 8 | |
| cellulose, microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] | 8 | |
| D&C yellow No. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] | 8 | |
| docusate sodium | INACTIVE INGREDIENT | F05Q2T2JA0 | SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] | 8 | |
| FD&C yellow no. 6 | INACTIVE INGREDIENT | H77VEI93A8 | SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] | 8 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] | 8 | |
| peppermint | INACTIVE INGREDIENT | V95R5KMY2B | SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] | 8 | |
| povidones | INACTIVE INGREDIENT | FZ989GH94E | SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] | 8 | |
| silicon dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] | 8 | |
| sodium benzoate | INACTIVE INGREDIENT | OJ245FE5EU | SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] | 8 | |
| Sodium Starch Glycolate Type A Potato | INACTIVE INGREDIENT | 5856J3G2A2 | SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] | 8 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53489-144 | SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 14 | Current NDC, Legacy NDC, 3 package rows | 20230126_d7fa3c79-9f26-415b-8039-eb2acabcf66b.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 |
|---|
| 53489-144-01 | 53489014401 | 100 TABLET in 1 BOTTLE, PLASTIC (53489-144-01) | 100 tablet | 1987-07-02 | 0000-00-00 | No | No | Current |
| 53489-144-05 | 53489014405 | 500 TABLET in 1 BOTTLE, PLASTIC (53489-144-05) | 500 tablet | 1987-07-02 | 0000-00-00 | No | No | Current |
| 53489-144-10 | 53489014410 | 1000 TABLET in 1 BOTTLE, PLASTIC (53489-144-10) | 1000 tablet | 1987-07-02 | 0000-00-00 | No | No | Current |