niacin

Generic: niacin

Labeler: macleods pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name niacin
Generic Name niacin
Labeler macleods pharmaceuticals limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

niacin 1000 mg/1

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-189
Product ID 33342-189_2b583ae0-4d24-bd44-e063-6394a90a0ced
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204934
Listing Expiration 2026-12-31
Marketing Start 2022-03-03

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 33342189
Hyphenated Format 33342-189

Supplemental Identifiers

RxCUI
1098134 1098141
UPC
0333342187116 0333342187109 0333342189103
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 ANDA204934 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1000 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (33342-189-10)
  • 100 TABLET in 1 BOTTLE (33342-189-11)
source: ndc

Packages (2)

33342-189-10 90 TABLET in 1 BOTTLE (33342-189-10) 33342-189-11 100 TABLET in 1 BOTTLE (33342-189-11)

Ingredients (1)

niacin (1000 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": "2b583ae0-4d24-bd44-e063-6394a90a0ced", "openfda": {"nui": ["N0000175594", "M0014839"], "upc": ["0333342187116", "0333342187109", "0333342189103"], "unii": ["2679MF687A"], "rxcui": ["1098134", "1098141"], "spl_set_id": ["52ad4a6a-81cc-4b03-b8b1-3bd9a1d4064e"], "pharm_class_cs": ["Nicotinic Acids [CS]"], "pharm_class_epc": ["Nicotinic Acid [EPC]"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (33342-189-10)", "package_ndc": "33342-189-10", "marketing_start_date": "20220303"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (33342-189-11)", "package_ndc": "33342-189-11", "marketing_start_date": "20220303"}], "brand_name": "Niacin", "product_id": "33342-189_2b583ae0-4d24-bd44-e063-6394a90a0ced", "dosage_form": "TABLET", "pharm_class": ["Nicotinic Acid [EPC]", "Nicotinic Acids [CS]"], "product_ndc": "33342-189", "generic_name": "Niacin", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Niacin", "active_ingredients": [{"name": "NIACIN", "strength": "1000 mg/1"}], "application_number": "ANDA204934", "marketing_category": "ANDA", "marketing_start_date": "20220303", "listing_expiration_date": "20261231"}