Spironolactone
- Product NDC
- 0603-5763
- 11-digit product format
- 006035763
- Labeler code
- 0603
- Product ID
- 0603-5763_403aff2d-d9d0-45ed-8082-744ca8e21cbc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- spironolactone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Par Pharmaceutical
- Application
- ANDA040750
- Marketing category
- ANDA
- Marketing start
- 2006-08-29
- Marketing end
- 2021-07-31
- Substance
- SPIRONOLACTONE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA]
- 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 |
|---|
| SPIRONOLACTONE | ACTIVE INGREDIENT | 27O7W4T232 | SPIRONOLACTONE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 2 | |
| SPIRONOLACTONE | ACTIVE MOIETY | 27O7W4T232 | SPIRONOLACTONE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 2 | |
| CALCIUM SULFATE | INACTIVE INGREDIENT | WAT0DDB505 | SPIRONOLACTONE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | SPIRONOLACTONE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 2 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | SPIRONOLACTONE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | SPIRONOLACTONE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 2 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | SPIRONOLACTONE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 2 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | SPIRONOLACTONE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 2 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | SPIRONOLACTONE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 2 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | SPIRONOLACTONE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 2 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | SPIRONOLACTONE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | SPIRONOLACTONE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.] | 2 | |
| SPIRONOLACTONE | ACTIVE INGREDIENT | 27O7W4T232 | SPIRONOLACTONE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| SPIRONOLACTONE | ACTIVE INGREDIENT | 27O7W4T232 | SPIRONOLACTONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| SPIRONOLACTONE | ACTIVE MOIETY | 27O7W4T232 | SPIRONOLACTONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| SPIRONOLACTONE | ACTIVE MOIETY | 27O7W4T232 | SPIRONOLACTONE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| CALCIUM SULFATE | INACTIVE INGREDIENT | WAT0DDB505 | SPIRONOLACTONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| CALCIUM SULFATE | INACTIVE INGREDIENT | WAT0DDB505 | SPIRONOLACTONE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | SPIRONOLACTONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | SPIRONOLACTONE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| HYPROMELLOSE | INACTIVE INGREDIENT | 3NXW29V3WO | SPIRONOLACTONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | SPIRONOLACTONE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | SPIRONOLACTONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | SPIRONOLACTONE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| POLYETHYLENE GLYCOL | INACTIVE INGREDIENT | 3WJQ0SDW1A | SPIRONOLACTONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | SPIRONOLACTONE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | SPIRONOLACTONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | SPIRONOLACTONE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | SPIRONOLACTONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | SPIRONOLACTONE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | SPIRONOLACTONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | SPIRONOLACTONE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | SPIRONOLACTONE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | SPIRONOLACTONE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | SPIRONOLACTONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | SPIRONOLACTONE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | SPIRONOLACTONE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0603-5763-21 | 00603576321 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0603-5763-21) | 2006-08-29 | 2021-07-31 | No | No | Current |
| 0603-5763-28 | 00603576328 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0603-5763-28) | 2006-08-29 | 2021-07-31 | No | No | Current |
| 0603-5763-30 | 00603576330 | 2500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0603-5763-30) | 2006-08-29 | 2021-07-31 | No | No | Current |
| 0603-5763-32 | 00603576332 | 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0603-5763-32) | 2006-08-29 | 2021-07-31 | No | No | Current |