nateglinide

Generic: nateglinide

Labeler: zydus lifesciences limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nateglinide
Generic Name nateglinide
Labeler zydus lifesciences limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

nateglinide 60 mg/1

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 70771-1015
Product ID 70771-1015_58be95eb-5701-463e-b80c-eb9b6c2a789d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205248
Listing Expiration 2026-12-31
Marketing Start 2016-10-27

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 707711015
Hyphenated Format 70771-1015

Supplemental Identifiers

RxCUI
311919 314142
UPC
0368382722164
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 ANDA205248 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 1000 TABLET, FILM COATED in 1 BOTTLE (70771-1015-0)
  • 100 TABLET, FILM COATED in 1 BOTTLE (70771-1015-1)
  • 30 TABLET, FILM COATED in 1 BOTTLE (70771-1015-3)
  • 10 BLISTER PACK in 1 CARTON (70771-1015-4) / 10 TABLET, FILM COATED in 1 BLISTER PACK (70771-1015-2)
  • 500 TABLET, FILM COATED in 1 BOTTLE (70771-1015-5)
  • 90 TABLET, FILM COATED in 1 BOTTLE (70771-1015-9)
source: ndc

Packages (6)

70771-1015-0 1000 TABLET, FILM COATED in 1 BOTTLE (70771-1015-0) 70771-1015-1 100 TABLET, FILM COATED in 1 BOTTLE (70771-1015-1) 70771-1015-3 30 TABLET, FILM COATED in 1 BOTTLE (70771-1015-3) 70771-1015-4 10 BLISTER PACK in 1 CARTON (70771-1015-4) / 10 TABLET, FILM COATED in 1 BLISTER PACK (70771-1015-2) 70771-1015-5 500 TABLET, FILM COATED in 1 BOTTLE (70771-1015-5) 70771-1015-9 90 TABLET, FILM COATED in 1 BOTTLE (70771-1015-9)

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": "58be95eb-5701-463e-b80c-eb9b6c2a789d", "openfda": {"nui": ["N0000175428", "N0000175448"], "upc": ["0368382722164"], "unii": ["41X3PWK4O2"], "rxcui": ["311919", "314142"], "spl_set_id": ["a82817dd-f8c4-4172-ba86-63c2beef456a"], "pharm_class_epc": ["Glinide [EPC]"], "pharm_class_moa": ["Potassium Channel Antagonists [MoA]"], "manufacturer_name": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (70771-1015-0)", "package_ndc": "70771-1015-0", "marketing_start_date": "20161027"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (70771-1015-1)", "package_ndc": "70771-1015-1", "marketing_start_date": "20161027"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (70771-1015-3)", "package_ndc": "70771-1015-3", "marketing_start_date": "20161027"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (70771-1015-4)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (70771-1015-2)", "package_ndc": "70771-1015-4", "marketing_start_date": "20161027"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (70771-1015-5)", "package_ndc": "70771-1015-5", "marketing_start_date": "20161027"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (70771-1015-9)", "package_ndc": "70771-1015-9", "marketing_start_date": "20161027"}], "brand_name": "Nateglinide", "product_id": "70771-1015_58be95eb-5701-463e-b80c-eb9b6c2a789d", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Glinide [EPC]", "Potassium Channel Antagonists [MoA]"], "product_ndc": "70771-1015", "generic_name": "Nateglinide", "labeler_name": "Zydus Lifesciences Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nateglinide", "active_ingredients": [{"name": "NATEGLINIDE", "strength": "60 mg/1"}], "application_number": "ANDA205248", "marketing_category": "ANDA", "marketing_start_date": "20161027", "listing_expiration_date": "20261231"}