Fosinopril sodium
- Product NDC
- 76282-201
- 11-digit product format
- 762820201
- Labeler code
- 76282
- Product ID
- 76282-201_ed121c1b-359c-471e-913c-4afdf9102c34
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fosinopril sodium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Exelan Pharmaceuticals, Inc.
- Application
- ANDA077222
- Marketing category
- ANDA
- Marketing start
- 2005-06-21
- Substance
- FOSINOPRIL SODIUM
- Active strength
- 20 mg/1
- Pharmacologic classes
- Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fosinopril sodium
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FOSINOPRIL SODIUM | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | NW2RTH6T2N |
| Rxcui | 857169, 857183, 857187 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76282-201-10 | Fosinopril sodium | 1000 in 1 BOTTLE | TABLET | 1000 | | 8 |
| 76282-201-90 | Fosinopril sodium | 90 in 1 BOTTLE | TABLET | 90 | | 8 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| FOSINOPRIL SODIUM | ACTIVE INGREDIENT | NW2RTH6T2N | FOSINOPRIL SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| FOSINOPRIL SODIUM | ACTIVE INGREDIENT | NW2RTH6T2N | FOSINOPRIL SODIUM TABLET [EXELAN PHARMACEUTICALS, INC.] | 2 | |
| FOSINOPRILAT | ACTIVE MOIETY | S312EY6ZT8 | FOSINOPRIL SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| FOSINOPRILAT | ACTIVE MOIETY | S312EY6ZT8 | FOSINOPRIL SODIUM TABLET [EXELAN PHARMACEUTICALS, INC.] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | FOSINOPRIL SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | FOSINOPRIL SODIUM TABLET [EXELAN PHARMACEUTICALS, INC.] | 2 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | FOSINOPRIL SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | FOSINOPRIL SODIUM TABLET [EXELAN PHARMACEUTICALS, INC.] | 2 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | FOSINOPRIL SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | FOSINOPRIL SODIUM TABLET [EXELAN PHARMACEUTICALS, INC.] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | FOSINOPRIL SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | FOSINOPRIL SODIUM TABLET [EXELAN PHARMACEUTICALS, INC.] | 2 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | FOSINOPRIL SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | FOSINOPRIL SODIUM TABLET [EXELAN PHARMACEUTICALS, INC.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76282-201 | FOSINOPRIL SODIUM TABLET [EXELAN PHARMACEUTICALS, INC.] | 8 | Current NDC, Legacy NDC, 2 package rows | 20230324_e2ff3171-a17a-456a-9272-ca1682b01d19.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 |
|---|
| 76282-201-10 | 76282020110 | 1000 TABLET in 1 BOTTLE (76282-201-10) | 1000 tablet | 2005-06-21 | 0000-00-00 | No | No | Current |
| 76282-201-90 | 76282020190 | 90 TABLET in 1 BOTTLE (76282-201-90) | 90 tablet | 2005-06-21 | 0000-00-00 | No | No | Current |