Spironolactone and Hydrochlorothiazide
- Product NDC
- 0378-0141
- 11-digit product format
- 003780141
- Labeler code
- 0378
- Product ID
- 0378-0141_44957b79-6f3a-48b0-b985-060aaa923bfd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- spironolactone and hydrochlorothiazide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA086513
- Marketing category
- ANDA
- Marketing start
- 2012-07-26
- Marketing end
- 2020-02-29
- Substance
- SPIRONOLACTONE; HYDROCHLOROTHIAZIDE
- Active strength
- 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
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| HYDROCHLOROTHIAZIDE | ACTIVE INGREDIENT | 0J48LPH2TH | SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| SPIRONOLACTONE | ACTIVE INGREDIENT | 27O7W4T232 | SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| HYDROCHLOROTHIAZIDE | ACTIVE MOIETY | 0J48LPH2TH | SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| SPIRONOLACTONE | ACTIVE MOIETY | 27O7W4T232 | SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| MENTHOL | INACTIVE INGREDIENT | L7T10EIP3A | SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| PEPPERMINT OIL | INACTIVE INGREDIENT | AV092KU4JH | SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
DailyMed RxNorm Mappings#