Inspra
- Product NDC
- 0025-1710
- 11-digit product format
- 000251710
- Labeler code
- 0025
- Product ID
- 0025-1710_b3853cca-756f-411a-b3d5-58d1152d9875
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- eplerenone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Pfizer Laboratories Div Pfizer Inc
- Application
- NDA021437
- Marketing category
- NDA
- Marketing start
- 2002-09-27
- Marketing end
- 0000-00-00
- Substance
- EPLERENONE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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 |
|---|
| EPLERENONE | ACTIVE INGREDIENT | 6995V82D0B | INSPRA (EPLERENONE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] | 10 | |
| EPLERENONE | ACTIVE MOIETY | 6995V82D0B | INSPRA (EPLERENONE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] | 10 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | INSPRA (EPLERENONE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] | 10 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | INSPRA (EPLERENONE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] | 10 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | INSPRA (EPLERENONE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] | 10 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | INSPRA (EPLERENONE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] | 10 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | INSPRA (EPLERENONE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] | 10 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | INSPRA (EPLERENONE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] | 10 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | INSPRA (EPLERENONE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] | 10 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | INSPRA (EPLERENONE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] | 10 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | INSPRA (EPLERENONE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] | 10 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | INSPRA (EPLERENONE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] | 10 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | INSPRA (EPLERENONE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] | 10 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | INSPRA (EPLERENONE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] | 10 | |
| eplerenone | ACTIVE INGREDIENT | 6995V82D0B | INSPRA (EPLERENONE) TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| eplerenone | ACTIVE MOIETY | 6995V82D0B | INSPRA (EPLERENONE) TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| cellulose, microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | INSPRA (EPLERENONE) TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| croscarmellose sodium | INACTIVE INGREDIENT | M28OL1HH48 | INSPRA (EPLERENONE) TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| ferric oxide red | INACTIVE INGREDIENT | 1K09F3G675 | INSPRA (EPLERENONE) TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| ferric oxide yellow | INACTIVE INGREDIENT | EX438O2MRT | INSPRA (EPLERENONE) TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | INSPRA (EPLERENONE) TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| lactose | INACTIVE INGREDIENT | J2B2A4N98G | INSPRA (EPLERENONE) TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | INSPRA (EPLERENONE) TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| polyethylene glycol | INACTIVE INGREDIENT | 3WJQ0SDW1A | INSPRA (EPLERENONE) TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| polysorbate 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | INSPRA (EPLERENONE) TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| sodium lauryl sulfate | INACTIVE INGREDIENT | 368GB5141J | INSPRA (EPLERENONE) TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| talc | INACTIVE INGREDIENT | 7SEV7J4R1U | INSPRA (EPLERENONE) TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | INSPRA (EPLERENONE) TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0025-1710 | INSPRA (EPLERENONE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC] | 22 | Legacy NDC | 20240919_a55a39ff-1bd5-428b-a64f-c44262e2f3ed.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 |
|---|
| 0025-1710-01 | 00025171001 | 30 TABLET, FILM COATED in 1 BOTTLE (0025-1710-01) | | 2002-09-27 | 0000-00-00 | No | No | Current |
| 0025-1710-02 | 00025171002 | 90 TABLET, FILM COATED in 1 BOTTLE (0025-1710-02) | | 2002-09-27 | 0000-00-00 | No | No | Current |
| 0025-1710-03 | 00025171003 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (0025-1710-03) > 1 TABLET, FILM COATED in 1 BLISTER PACK | 100 blister pack | 2002-09-27 | 0000-00-00 | No | No | Current |