nateglinide

Generic: nateglinide

Labeler: zydus pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

nateglinide 120 mg/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 68382-722
Product ID 68382-722_061a2260-2804-4753-b443-17943eca74dd
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 68382722
Hyphenated Format 68382-722

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 ANDA205248 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 120 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (68382-722-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (68382-722-05)
  • 30 TABLET, FILM COATED in 1 BOTTLE (68382-722-06)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (68382-722-10)
  • 90 TABLET, FILM COATED in 1 BOTTLE (68382-722-16)
  • 10 BLISTER PACK in 1 CARTON (68382-722-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (6)

68382-722-01 100 TABLET, FILM COATED in 1 BOTTLE (68382-722-01) 68382-722-05 500 TABLET, FILM COATED in 1 BOTTLE (68382-722-05) 68382-722-06 30 TABLET, FILM COATED in 1 BOTTLE (68382-722-06) 68382-722-10 1000 TABLET, FILM COATED in 1 BOTTLE (68382-722-10) 68382-722-16 90 TABLET, FILM COATED in 1 BOTTLE (68382-722-16) 68382-722-77 10 BLISTER PACK in 1 CARTON (68382-722-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

nateglinide (120 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": "061a2260-2804-4753-b443-17943eca74dd", "openfda": {"nui": ["N0000175428", "N0000175448"], "unii": ["41X3PWK4O2"], "rxcui": ["311919", "314142"], "spl_set_id": ["88698921-cd8f-4d41-96e6-ff671913c5c3"], "pharm_class_epc": ["Glinide [EPC]"], "pharm_class_moa": ["Potassium Channel Antagonists [MoA]"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (68382-722-01)", "package_ndc": "68382-722-01", "marketing_start_date": "20161027"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (68382-722-05)", "package_ndc": "68382-722-05", "marketing_start_date": "20161027"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68382-722-06)", "package_ndc": "68382-722-06", "marketing_start_date": "20161027"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (68382-722-10)", "package_ndc": "68382-722-10", "marketing_start_date": "20161027"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68382-722-16)", "package_ndc": "68382-722-16", "marketing_start_date": "20161027"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (68382-722-77)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "68382-722-77", "marketing_start_date": "20161027"}], "brand_name": "Nateglinide", "product_id": "68382-722_061a2260-2804-4753-b443-17943eca74dd", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Glinide [EPC]", "Potassium Channel Antagonists [MoA]"], "product_ndc": "68382-722", "generic_name": "Nateglinide", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nateglinide", "active_ingredients": [{"name": "NATEGLINIDE", "strength": "120 mg/1"}], "application_number": "ANDA205248", "marketing_category": "ANDA", "marketing_start_date": "20161027", "listing_expiration_date": "20261231"}