Fosinopril Sodium and Hydrochlorothiazide is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Aurobindo Pharma Limited. The primary component is Fosinopril Sodium; Hydrochlorothiazide.
| Product ID | 65862-308_0c4c1d56-df5a-46cf-9da0-48423264dbc4 |
| NDC | 65862-308 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Fosinopril Sodium and Hydrochlorothiazide |
| Generic Name | Fosinopril Sodium And Hydrochlorothiazide |
| Dosage Form | Tablet |
| Route of Administration | ORAL |
| Marketing Start Date | 2009-07-09 |
| Marketing Category | ANDA / DRUG FOR FURTHER PROCESSING |
| Application Number | ANDA079245 |
| Labeler Name | Aurobindo Pharma Limited |
| Substance Name | FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE |
| Active Ingredient Strength | 10 mg/1; mg/1 |
| Pharm Classes | Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
| Marketing Start Date | 2009-07-09 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA079245 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2009-07-09 |
| Marketing Category | ANDA |
| Application Number | ANDA079245 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2009-07-09 |
| Marketing Category | ANDA |
| Application Number | ANDA079245 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2009-07-09 |
| Marketing Category | ANDA |
| Application Number | ANDA079245 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2010-11-02 |
| Marketing End Date | 2013-07-26 |
| Ingredient | Strength |
|---|---|
| FOSINOPRIL SODIUM | 10 mg/1 |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 23155-060 | Fosinopril Sodium and Hydrochlorothiazide | Fosinopril Sodium and Hydrochlorothiazide Tablet |
| 23155-061 | Fosinopril Sodium and Hydrochlorothiazide | Fosinopril Sodium and Hydrochlorothiazide |
| 57237-026 | Fosinopril Sodium and Hydrochlorothiazide | Fosinopril Sodium and Hydrochlorothiazide |
| 57237-027 | Fosinopril Sodium and Hydrochlorothiazide | Fosinopril Sodium and Hydrochlorothiazide |
| 63304-403 | Fosinopril Sodium and Hydrochlorothiazide | Fosinopril Sodium and Hydrochlorothiazide |
| 63304-404 | Fosinopril Sodium and Hydrochlorothiazide | Fosinopril Sodium and Hydrochlorothiazide |
| 63629-6993 | Fosinopril Sodium and Hydrochlorothiazide | Fosinopril Sodium and Hydrochlorothiazide |
| 65862-308 | Fosinopril Sodium and Hydrochlorothiazide | Fosinopril Sodium and Hydrochlorothiazide |
| 65862-309 | Fosinopril Sodium and Hydrochlorothiazide | Fosinopril Sodium and Hydrochlorothiazide |
| 68462-554 | Fosinopril Sodium and Hydrochlorothiazide | Fosinopril Sodium and Hydrochlorothiazide |
| 68462-555 | Fosinopril Sodium and Hydrochlorothiazide | Fosinopril Sodium and Hydrochlorothiazide |
| 69097-972 | Fosinopril Sodium and Hydrochlorothiazide | Fosinopril Sodium and Hydrochlorothiazide |
| 69097-973 | Fosinopril Sodium and Hydrochlorothiazide | Fosinopril Sodium and Hydrochlorothiazide |