NATEGLINIDE

Orange BookUNIISPLATC A10BX03

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

Identification

ManufacturerRising Pharma Holdings, Inc.

CountryUS (United States)

ATC codeA10BX03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
1657175901
100 TABLET in 1 BOTTLE (16571-759-01)
ndc11
1657175909
90 TABLET in 1 BOTTLE (16571-759-09)
ndc11
1657175950
500 TABLET in 1 BOTTLE (16571-759-50)

Annotations

UNII (FDA Substance ID)

41X3PWK4O2

NATEGLINIDE

RxCUI 274332

Orange Book

A205544

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": "16571-759_9ed1dbe4-49df-4d94-9e8b-3cdc081a3dd0",
  "productndc": "16571-759",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "205544",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "60MG",
        "product_no": "001",
        "approval_date": "Jun 18, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "120MG",
        "product_no": "002",
        "approval_date": "Jun 18, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NATEGLINIDE",
  "proprietary_name": "NATEGLINIDE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA205544",
  "marketing_category": "ANDA",
  "nonproprietary_name": "NATEGLINIDE",
  "start_marketing_date": "20201216",
  "active_numerator_strength": "120"
}

Related drugs

Other records sharing ATC code A10BX03.

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