NATEGLINIDE

Orange BookUNIISPLATC A10BX03

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerNivagen Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeA10BX03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7583420501
100 TABLET, COATED in 1 BOTTLE (75834-205-01)

Annotations

UNII (FDA Substance ID)

41X3PWK4O2

NATEGLINIDE

RxCUI 274332

Orange Book

A206432

ABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "41X3PWK4O2",
    "rxcui": "274332",
    "inchikey": "OELFLUMRDSZNSF-BRWVUGGUSA-N",
    "display_name": "NATEGLINIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "f7b28951-76d2-cabd-64a1-b74aa225c6e9": {
      "match": "brand_token",
      "title": "NATEGLINIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]",
      "spl_version": "11",
      "published_date": "2025-09-01"
    }
  },
  "productid": "75834-205_4b5b12e1-59db-4ec2-a2be-9b60abc79ebf",
  "productndc": "75834-205",
  "dosage_form": "TABLET, COATED",
  "orange_book": {
    "appl_no": "206432",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "60MG",
        "product_no": "001",
        "approval_date": "Apr 19, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "120MG",
        "product_no": "002",
        "approval_date": "Apr 19, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NATEGLINIDE",
  "proprietary_name": "NATEGLINIDE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA206432",
  "marketing_category": "ANDA",
  "nonproprietary_name": "NATEGLINIDE",
  "start_marketing_date": "20190925",
  "active_numerator_strength": "60"
}

Related drugs

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