SPIRONOLACTONE
- Product NDC
- 63629-5341
- 11-digit product format
- 636295341
- Labeler code
- 63629
- Product ID
- 63629-5341_46e3e7f2-edb1-4ac9-ada9-8ed0a4a82e68
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SPIRONOLACTONE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA089424
- Marketing category
- ANDA
- Marketing start
- 1986-07-23
- Substance
- SPIRONOLACTONE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- SPIRONOLACTONE
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SPIRONOLACTONE | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 27O7W4T232 |
| Rxcui | 198223 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63629-5341-1 | SPIRONOLACTONE | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1015 |
| 63629-5341-2 | SPIRONOLACTONE | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 1015 |
| 63629-5341-3 | SPIRONOLACTONE | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 1015 |
| 63629-5341-4 | SPIRONOLACTONE | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 1015 |
| 63629-5341-5 | SPIRONOLACTONE | 14 in 1 BOTTLE | TABLET, FILM COATED | 14 | | 1015 |
| 63629-5341-6 | SPIRONOLACTONE | 10 in 1 BOTTLE | TABLET, FILM COATED | 10 | | 1015 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| SPIRONOLACTONE | ACTIVE INGREDIENT | 27O7W4T232 | SPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 1000 | |
| SPIRONOLACTONE | ACTIVE MOIETY | 27O7W4T232 | SPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 1000 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | SPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 1000 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | SPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 1000 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | SPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 1000 | |
| DOCUSATE SODIUM | INACTIVE INGREDIENT | F05Q2T2JA0 | SPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 1000 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | SPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 1000 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | SPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 1000 | |
| POLYDEXTROSE | INACTIVE INGREDIENT | VH2XOU12IE | SPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 1000 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | SPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 1000 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | SPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 1000 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | SPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 1000 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | SPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 1000 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | SPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 1000 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | SPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 1000 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | SPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 1000 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63629-5341 | SPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 1014 | Current NDC, Legacy NDC, 6 package rows | 20231128_cae68fd6-5161-4650-bcde-6db98cbe6c8b.zip |
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 |
|---|
| 63629-5341-1 | 63629534101 | 30 TABLET, FILM COATED in 1 BOTTLE (63629-5341-1) | 2014-05-16 | 0000-00-00 | No | No | Current |
| 63629-5341-2 | 63629534102 | 60 TABLET, FILM COATED in 1 BOTTLE (63629-5341-2) | 2017-10-16 | 0000-00-00 | No | No | Current |
| 63629-5341-3 | 63629534103 | 90 TABLET, FILM COATED in 1 BOTTLE (63629-5341-3) | 2016-02-18 | 0000-00-00 | No | No | Current |
| 63629-5341-4 | 63629534104 | 100 TABLET, FILM COATED in 1 BOTTLE (63629-5341-4) | 2023-03-09 | 0000-00-00 | No | No | Current |
| 63629-5341-5 | 63629534105 | 14 TABLET, FILM COATED in 1 BOTTLE (63629-5341-5) | 2023-03-09 | 0000-00-00 | No | No | Current |
| 63629-5341-6 | 63629534106 | 10 TABLET, FILM COATED in 1 BOTTLE (63629-5341-6) | 2023-03-09 | 0000-00-00 | No | No | Current |