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NDC 47335-0613-88 NIACIN 1000 mg/1 Details
NIACIN 1000 mg/1
NIACIN is a ORAL TABLET, FILM COATED, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc.. The primary component is NIACIN.
MedlinePlus Drug Summary
Niacin is used with diet changes (restriction of cholesterol and fat intake) to reduce the amount of cholesterol (a fat-like substance) and other fatty substances in your blood and to increase the amount of high density lipoprotein (HDL; ''good cholesterol''). Niacin can be used in a number of situations including the following: alone or in combination with other medications, such as HMG-CoA inhibitors (statins) or bile acid-binding resins; to decrease the risk of another heart attack in patients with high cholesterol who have had a heart attack; to prevent worsening of atherosclerosis (buildup of cholesterol and fats along the walls of the blood vessels) in patients with high cholesterol and coronary artery disease; to reduce the amount of triglycerides (other fatty substances) in the blood in patients with very high triglycerides who are at risk of pancreatic disease (conditions affecting the pancreas, a gland that produces fluid to break down food and hormones to control blood sugar). Niacin is also used to prevent and treat pellagra (niacin deficiency), a disease caused by inadequate diet and other medical problems. Niacin is a B-complex vitamin. At therapeutic doses, niacin is a cholesterol-lowering medication. Results of a clinical study in people with heart disease and well-controlled cholesterol levels that compared people who took niacin and simvastatin with people who took simvastatin alone and found similar results for the two groups in the rate of heart attacks or strokes. Taking niacin along with simvastatin or lovastatin also has not been shown to reduce the risk of heart disease or death compared with the use of niacin, simvastatin, or lovastatin alone. Talk to your doctor if you have questions about the risks and benefits of treating increased amounts of cholesterol in your blood with niacin and other medications.
Related Packages: 47335-0613-88Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Niacin
Product Information
NDC | 47335-0613 |
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Product ID | 47335-613_bc18daa3-5321-43bd-9d00-dabd9adac571 |
Associated GPIs | 39450050000470 |
GCN Sequence Number | 033366 |
GCN Sequence Number Description | niacin TAB ER 24H 1000 MG ORAL |
HIC3 | M4E |
HIC3 Description | LIPOTROPICS |
GCN | 42333 |
HICL Sequence Number | 001064 |
HICL Sequence Number Description | NIACIN |
Brand/Generic | Generic |
Proprietary Name | NIACIN |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | NIACIN |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
Route | ORAL |
Active Ingredient Strength | 1000 |
Active Ingredient Units | mg/1 |
Substance Name | NIACIN |
Labeler Name | Sun Pharmaceutical Industries, Inc. |
Pharmaceutical Class | Nicotinic Acid [EPC], Nicotinic Acids [CS] |
DEA Schedule | n/a |
Marketing Category | ANDA |
Application Number | ANDA200484 |
Listing Certified Through | 2024-12-31 |
Package
NDC 47335-0613-88 (47335061388)
NDC Package Code | 47335-613-88 |
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Billing NDC | 47335061388 |
Package | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-613-88) |
Marketing Start Date | 2014-06-27 |
NDC Exclude Flag | N |
Pricing Information | N/A |