Nateglinide

Orange BookUNIISPLATC A10BX03

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

Identification

ManufacturerDr. Reddy's Laboratories Limited

CountryUS (United States)

ATC codeA10BX03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
5511132801
100 TABLET in 1 BOTTLE (55111-328-01)
ndc11
5511132805
500 TABLET in 1 BOTTLE (55111-328-05)
ndc11
5511132830
30 TABLET in 1 BOTTLE (55111-328-30)
ndc11
5511132878
10 BLISTER PACK in 1 CARTON (55111-328-78) / 10 TABLET in 1 BLISTER PACK (55111-328-79)
ndc11
5511132890
90 TABLET in 1 BOTTLE (55111-328-90)

Annotations

UNII (FDA Substance ID)

41X3PWK4O2

NATEGLINIDE

RxCUI 274332

Orange Book

A077461

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": "55111-328_4e11dea8-92ab-762e-9808-fad73bf42330",
  "productndc": "55111-328",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "077461",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "60MG",
        "product_no": "001",
        "approval_date": "Sep 9, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "120MG",
        "product_no": "002",
        "approval_date": "Sep 9, 2009"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NATEGLINIDE",
  "proprietary_name": "Nateglinide",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA077461",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Nateglinide",
  "start_marketing_date": "20090909",
  "active_numerator_strength": "60"
}

Related drugs

Other records sharing ATC code A10BX03.

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