nateglinide

Generic: nateglinide

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

Drug Facts

Product Profile

Brand Name nateglinide
Generic Name nateglinide
Labeler nivagen pharmaceuticals, inc.
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

nateglinide 60 mg/1

Manufacturer
Nivagen Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 75834-205
Product ID 75834-205_4b5b12e1-59db-4ec2-a2be-9b60abc79ebf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206432
Listing Expiration 2026-12-31
Marketing Start 2019-09-25

Pharmacologic Class

Established (EPC)
glinide [epc]
Mechanism of Action
potassium channel antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 75834205
Hyphenated Format 75834-205

Supplemental Identifiers

RxCUI
311919 314142
UPC
0375834205014 0375834206011
UNII
41X3PWK4O2
NUI
N0000175428 N0000175448

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 nateglinide (source: ndc)
Generic Name nateglinide (source: ndc)
Application Number ANDA206432 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 100 TABLET, COATED in 1 BOTTLE (75834-205-01)
source: ndc

Packages (1)

75834-205-01 100 TABLET, COATED in 1 BOTTLE (75834-205-01)

Ingredients (1)

nateglinide (60 mg/1)

Linked Drug Pages (1)

NATEGLINIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4b5b12e1-59db-4ec2-a2be-9b60abc79ebf", "openfda": {"nui": ["N0000175428", "N0000175448"], "upc": ["0375834205014", "0375834206011"], "unii": ["41X3PWK4O2"], "rxcui": ["311919", "314142"], "spl_set_id": ["21b211b5-cc92-490f-9903-42fff6a946cd"], "pharm_class_epc": ["Glinide [EPC]"], "pharm_class_moa": ["Potassium Channel Antagonists [MoA]"], "manufacturer_name": ["Nivagen Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, COATED in 1 BOTTLE (75834-205-01)", "package_ndc": "75834-205-01", "marketing_start_date": "20190925"}], "brand_name": "NATEGLINIDE", "product_id": "75834-205_4b5b12e1-59db-4ec2-a2be-9b60abc79ebf", "dosage_form": "TABLET, COATED", "pharm_class": ["Glinide [EPC]", "Potassium Channel Antagonists [MoA]"], "product_ndc": "75834-205", "generic_name": "NATEGLINIDE", "labeler_name": "Nivagen Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NATEGLINIDE", "active_ingredients": [{"name": "NATEGLINIDE", "strength": "60 mg/1"}], "application_number": "ANDA206432", "marketing_category": "ANDA", "marketing_start_date": "20190925", "listing_expiration_date": "20261231"}