niacin

Generic: niacin

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name niacin
Generic Name niacin
Labeler chartwell rx, llc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

niacin 1000 mg/1

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-498
Product ID 62135-498_456edffe-25de-6095-e063-6294a90a7d57
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203899
Listing Expiration 2026-12-31
Marketing Start 2017-02-16

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62135498
Hyphenated Format 62135-498

Supplemental Identifiers

RxCUI
1098134 1098141
UPC
0362135497903 0362135498900
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 ANDA203899 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1000 mg/1
source: ndc
Packaging
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (62135-498-90)
source: ndc

Packages (1)

62135-498-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (62135-498-90)

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": "456edffe-25de-6095-e063-6294a90a7d57", "openfda": {"nui": ["N0000175594", "M0014839"], "upc": ["0362135497903", "0362135498900"], "unii": ["2679MF687A"], "rxcui": ["1098134", "1098141"], "spl_set_id": ["568c3a99-b6e8-48b4-bb68-867bbcefa027"], "pharm_class_cs": ["Nicotinic Acids [CS]"], "pharm_class_epc": ["Nicotinic Acid [EPC]"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (62135-498-90)", "package_ndc": "62135-498-90", "marketing_start_date": "20230308"}], "brand_name": "NIACIN", "product_id": "62135-498_456edffe-25de-6095-e063-6294a90a7d57", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Nicotinic Acid [EPC]", "Nicotinic Acids [CS]"], "product_ndc": "62135-498", "generic_name": "Niacin", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NIACIN", "active_ingredients": [{"name": "NIACIN", "strength": "1000 mg/1"}], "application_number": "ANDA203899", "marketing_category": "ANDA", "marketing_start_date": "20170216", "listing_expiration_date": "20261231"}