niacin

Generic: niacin

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name niacin
Generic Name niacin
Labeler sun pharmaceutical industries, inc.
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

niacin 500 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 47335-539
Product ID 47335-539_bc18daa3-5321-43bd-9d00-dabd9adac571
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200484
Listing Expiration 2026-12-31
Marketing Start 2014-06-27

Pharmacologic Class

Established (EPC)
nicotinic acid [epc]
Chemical Structure
nicotinic acids [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 47335539
Hyphenated Format 47335-539

Supplemental Identifiers

RxCUI
1098134 1098141 1098143
UPC
0347335613810 0347335614817 0347335539813
UNII
2679MF687A
NUI
N0000175594 M0014839

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name niacin (source: ndc)
Generic Name niacin (source: ndc)
Application Number ANDA200484 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-539-08)
  • 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-539-18)
  • 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-539-81)
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-539-83)
  • 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-539-88)
source: ndc

Packages (5)

47335-539-08 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-539-08) 47335-539-18 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-539-18) 47335-539-81 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-539-81) 47335-539-83 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-539-83) 47335-539-88 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-539-88)

Ingredients (1)

niacin (500 mg/1)

Linked Drug Pages (1)

NIACIN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "bc18daa3-5321-43bd-9d00-dabd9adac571", "openfda": {"nui": ["N0000175594", "M0014839"], "upc": ["0347335613810", "0347335614817", "0347335539813"], "unii": ["2679MF687A"], "rxcui": ["1098134", "1098141", "1098143"], "spl_set_id": ["8e290f96-e8c6-47fd-863f-1c9480f28d9b"], "pharm_class_cs": ["Nicotinic Acids [CS]"], "pharm_class_epc": ["Nicotinic Acid [EPC]"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-539-08)", "package_ndc": "47335-539-08", "marketing_start_date": "20140627"}, {"sample": false, "description": "1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-539-18)", "package_ndc": "47335-539-18", "marketing_start_date": "20140627"}, {"sample": false, "description": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-539-81)", "package_ndc": "47335-539-81", "marketing_start_date": "20140627"}, {"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-539-83)", "package_ndc": "47335-539-83", "marketing_start_date": "20140627"}, {"sample": false, "description": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-539-88)", "package_ndc": "47335-539-88", "marketing_start_date": "20140627"}], "brand_name": "NIACIN", "product_id": "47335-539_bc18daa3-5321-43bd-9d00-dabd9adac571", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Nicotinic Acid [EPC]", "Nicotinic Acids [CS]"], "product_ndc": "47335-539", "generic_name": "NIACIN", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NIACIN", "active_ingredients": [{"name": "NIACIN", "strength": "500 mg/1"}], "application_number": "ANDA200484", "marketing_category": "ANDA", "marketing_start_date": "20140627", "listing_expiration_date": "20261231"}