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NDC 65162-0576-03 Calcitriol 0.5 ug/1 Details
Calcitriol 0.5 ug/1
Calcitriol is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Amneal Pharmaceuticals LLC. The primary component is CALCITRIOL.
MedlinePlus Drug Summary
Calcitriol is used to treat and prevent low levels of calcium and bone disease in patients whose kidneys or parathyroid glands (glands in the neck that release natural substances to control the amount of calcium in the blood) are not working normally. It is also used to treat secondary hyperparathyroidism (a condition in which the body produces too much parathyroid hormone [PTH; a natural substance needed to control the amount of calcium in the blood]) and metabolic bone disease in people with kidney disease. Calcitriol is in a class of medications called vitamin D analogs. It works by helping the body to use more of the calcium found in foods or supplements and regulating the body's production of parathyroid hormone.
Related Packages: 65162-0576-03Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Calcitriol
Product Information
| NDC | 65162-0576 |
|---|---|
| Product ID | 65162-576_38295301-0c5f-45da-aedd-ebe0d71ae647 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Calcitriol |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Calcitriol |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE |
| Route | ORAL |
| Active Ingredient Strength | 0.5 |
| Active Ingredient Units | ug/1 |
| Substance Name | CALCITRIOL |
| Labeler Name | Amneal Pharmaceuticals LLC |
| Pharmaceutical Class | Cholecalciferol [CS], Vitamin D3 Analog [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA203289 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 65162-0576-03 (65162057603)
| NDC Package Code | 65162-576-03 |
|---|---|
| Billing NDC | 65162057603 |
| Package | 30 CAPSULE in 1 BOTTLE (65162-576-03) |
| Marketing Start Date | 2017-06-18 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |