nateglinide

Generic: nateglinide

Labeler: strides pharma science limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nateglinide
Generic Name nateglinide
Labeler strides pharma science limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

nateglinide 120 mg/1

Manufacturer
Strides Pharma Science Limited

Identifiers & Regulatory

Product NDC 64380-168
Product ID 64380-168_774c246f-3d18-40d4-882f-4786d9382883
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077463
Listing Expiration 2026-12-31
Marketing Start 2022-05-09

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 64380168
Hyphenated Format 64380-168

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 ANDA077463 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 120 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (64380-168-01)
  • 90 TABLET in 1 BOTTLE, PLASTIC (64380-168-02)
source: ndc

Packages (2)

64380-168-01 100 TABLET in 1 BOTTLE, PLASTIC (64380-168-01) 64380-168-02 90 TABLET in 1 BOTTLE, PLASTIC (64380-168-02)

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": "774c246f-3d18-40d4-882f-4786d9382883", "openfda": {"nui": ["N0000175428", "N0000175448"], "unii": ["41X3PWK4O2"], "rxcui": ["311919", "314142"], "spl_set_id": ["0ccf9b07-3c21-482d-abeb-a06ceb482c7b"], "pharm_class_epc": ["Glinide [EPC]"], "pharm_class_moa": ["Potassium Channel Antagonists [MoA]"], "manufacturer_name": ["Strides Pharma Science Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (64380-168-01)", "package_ndc": "64380-168-01", "marketing_start_date": "20220509"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (64380-168-02)", "package_ndc": "64380-168-02", "marketing_start_date": "20220907"}], "brand_name": "Nateglinide", "product_id": "64380-168_774c246f-3d18-40d4-882f-4786d9382883", "dosage_form": "TABLET", "pharm_class": ["Glinide [EPC]", "Potassium Channel Antagonists [MoA]"], "product_ndc": "64380-168", "generic_name": "nateglinide", "labeler_name": "Strides Pharma Science Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nateglinide", "active_ingredients": [{"name": "NATEGLINIDE", "strength": "120 mg/1"}], "application_number": "ANDA077463", "marketing_category": "ANDA", "marketing_start_date": "20220509", "listing_expiration_date": "20261231"}