nateglinide

Generic: nateglinide

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nateglinide
Generic Name nateglinide
Labeler rising pharma holdings, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

nateglinide 60 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 16571-758
Product ID 16571-758_9ed1dbe4-49df-4d94-9e8b-3cdc081a3dd0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205544
Listing Expiration 2026-12-31
Marketing Start 2020-12-16

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 16571758
Hyphenated Format 16571-758

Supplemental Identifiers

RxCUI
311919 314142
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 ANDA205544 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (16571-758-01)
  • 90 TABLET in 1 BOTTLE (16571-758-09)
  • 500 TABLET in 1 BOTTLE (16571-758-50)
source: ndc

Packages (3)

16571-758-01 100 TABLET in 1 BOTTLE (16571-758-01) 16571-758-09 90 TABLET in 1 BOTTLE (16571-758-09) 16571-758-50 500 TABLET in 1 BOTTLE (16571-758-50)

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": "9ed1dbe4-49df-4d94-9e8b-3cdc081a3dd0", "openfda": {"nui": ["N0000175428", "N0000175448"], "unii": ["41X3PWK4O2"], "rxcui": ["311919", "314142"], "spl_set_id": ["b41f4180-96a7-411d-b827-5021e534f556"], "pharm_class_epc": ["Glinide [EPC]"], "pharm_class_moa": ["Potassium Channel Antagonists [MoA]"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (16571-758-01)", "package_ndc": "16571-758-01", "marketing_start_date": "20201216"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (16571-758-09)", "package_ndc": "16571-758-09", "marketing_start_date": "20201216"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (16571-758-50)", "package_ndc": "16571-758-50", "marketing_start_date": "20201216"}], "brand_name": "NATEGLINIDE", "product_id": "16571-758_9ed1dbe4-49df-4d94-9e8b-3cdc081a3dd0", "dosage_form": "TABLET", "pharm_class": ["Glinide [EPC]", "Potassium Channel Antagonists [MoA]"], "product_ndc": "16571-758", "generic_name": "NATEGLINIDE", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NATEGLINIDE", "active_ingredients": [{"name": "NATEGLINIDE", "strength": "60 mg/1"}], "application_number": "ANDA205544", "marketing_category": "ANDA", "marketing_start_date": "20201216", "listing_expiration_date": "20261231"}