niacin

Generic: niacin

Labeler: lupin pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name niacin
Generic Name niacin
Labeler lupin pharmaceuticals, inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

niacin 750 mg/1

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-222
Product ID 68180-222_309a40e8-333f-478a-8a94-beff7f3ca5b2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090892
Listing Expiration 2026-12-31
Marketing Start 2014-03-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68180222
Hyphenated Format 68180-222

Supplemental Identifiers

RxCUI
1098134 1098141 1098143
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 ANDA090892 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 750 mg/1
source: ndc
Packaging
  • 16 HOW SUPPLIED/STORAGE AND HANDLING Niacin extended-release tablets USP are supplied as orange coloured, film-coated, capsule-shaped tablets containing 500 mg of niacin in an extended-release formulation. Tablets are debossed "LU" on one side and "D11" on the other side. Tablets are supplied in bottles of 100 and 1000s as shown below. 500 mg tablets: bottles of 100 - NDC# 68180-221-01 500 mg tablets: bottles of 1000 - NDC# 68180-221-03 Niacin extended-release tablets USP are supplied as orange coloured, film-coated, capsule-shaped tablets containing 750 mg of niacin in an extended-release formulation. Tablets are debossed "LU" on one side and "D12" on the other side. Tablets are supplied in bottles of 100 and 500s as shown below. 750 mg tablets: bottles of 100 - NDC# 68180-222-01 750 mg tablets: bottles of 500 - NDC# 68180-222-02 Niacin extended-release tablets USP are supplied as orange coloured, film-coated, oval-shaped tablets containing 1000 mg of niacin in an extended-release formulation. Tablets are debossed "LU" on one side and "D13" on the other side. Tablets are supplied in bottles of 100 and 1000s as shown below. 1000 mg tablets: bottles of 100 - NDC# 68180-223-01 1000 mg tablets: bottles of 1000 - NDC# 68180-223-03 Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NIACIN EXTENDED-RELEASE TABLETS 500 mg Rx Only NDC 68180-221-01 100 TABLETS NIACIN EXTENDED-RELEASE TABLETS 750 mg Rx Only NDC 68180-222-01 100 TABLETS NIACIN EXTENDED-RELEASE TABLETS 1000 mg Rx Only NDC 68180-223-01 100 TABLETS NIACIN EXTENDED-RELEASE TABLETS 500 mg Rx Only NDC 68180-221-01 100 TABLETS NIACIN EXTENDED-RELEASE TABLETS 750 mg Rx Only NDC 68180-222-01 100 TABLETS NIACIN EXTENDED-RELEASE TABLETS 1000 mg Rx Only NDC 68180-223-01 100 TABLETS
source: label

Packages (0)

No package records.

Ingredients (1)

niacin (750 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": "309a40e8-333f-478a-8a94-beff7f3ca5b2", "openfda": {"nui": ["N0000175594", "M0014839"], "unii": ["2679MF687A"], "rxcui": ["1098134", "1098141", "1098143"], "spl_set_id": ["92b3ec1d-0dc7-4bde-9817-57b1bdf7f0b9"], "pharm_class_cs": ["Nicotinic Acids [CS]"], "pharm_class_epc": ["Nicotinic Acid [EPC]"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "NIACIN", "product_id": "68180-222_309a40e8-333f-478a-8a94-beff7f3ca5b2", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Nicotinic Acid [EPC]", "Nicotinic Acids [CS]"], "product_ndc": "68180-222", "generic_name": "NIACIN", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NIACIN", "active_ingredients": [{"name": "NIACIN", "strength": "750 mg/1"}], "application_number": "ANDA090892", "marketing_category": "ANDA", "marketing_start_date": "20140320", "listing_expiration_date": "20261231"}