niacin

Generic: niacin

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name niacin
Generic Name niacin
Labeler avpak
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

niacin 500 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-584
Product ID 50268-584_4ba8c8c4-810e-b1f2-e063-6394a90a2d32
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203578
Listing Expiration 2027-12-31
Marketing Start 2017-09-14

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50268584
Hyphenated Format 50268-584

Supplemental Identifiers

RxCUI
1098134 1098141
UNII
2679MF687A
NUI
N0000175594 M0014839

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 ANDA203578 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-584-13) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (50268-584-11)
source: ndc

Packages (1)

50268-584-13 30 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-584-13) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (50268-584-11)

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": "4ba8c8c4-810e-b1f2-e063-6394a90a2d32", "openfda": {"nui": ["N0000175594", "M0014839"], "unii": ["2679MF687A"], "rxcui": ["1098134", "1098141"], "spl_set_id": ["dd60fe81-3d54-4a29-9502-601be89c575e"], "pharm_class_cs": ["Nicotinic Acids [CS]"], "pharm_class_epc": ["Nicotinic Acid [EPC]"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-584-13)  / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (50268-584-11)", "package_ndc": "50268-584-13", "marketing_start_date": "20170914"}], "brand_name": "Niacin", "product_id": "50268-584_4ba8c8c4-810e-b1f2-e063-6394a90a2d32", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Nicotinic Acid [EPC]", "Nicotinic Acids [CS]"], "product_ndc": "50268-584", "generic_name": "Niacin", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Niacin", "active_ingredients": [{"name": "NIACIN", "strength": "500 mg/1"}], "application_number": "ANDA203578", "marketing_category": "ANDA", "marketing_start_date": "20170914", "listing_expiration_date": "20271231"}