Nateglinide

Orange BookUNIISPLATC A10BX03

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

Identification

ManufacturerZydus Lifesciences Limited

CountryUS (United States)

ATC codeA10BX03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
7077110150
1000 TABLET, FILM COATED in 1 BOTTLE (70771-1015-0)
ndc11
7077110151
100 TABLET, FILM COATED in 1 BOTTLE (70771-1015-1)
ndc11
7077110153
30 TABLET, FILM COATED in 1 BOTTLE (70771-1015-3)
ndc11
7077110154
10 BLISTER PACK in 1 CARTON (70771-1015-4) / 10 TABLET, FILM COATED in 1 BLISTER PACK (70771-1015-2)
ndc11
7077110155
500 TABLET, FILM COATED in 1 BOTTLE (70771-1015-5)
ndc11
7077110159
90 TABLET, FILM COATED in 1 BOTTLE (70771-1015-9)

Annotations

UNII (FDA Substance ID)

41X3PWK4O2

NATEGLINIDE

RxCUI 274332

Orange Book

A205248

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": "70771-1015_58be95eb-5701-463e-b80c-eb9b6c2a789d",
  "productndc": "70771-1015",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "205248",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "60MG",
        "product_no": "001",
        "approval_date": "Jul 6, 2016"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "120MG",
        "product_no": "002",
        "approval_date": "Jul 6, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NATEGLINIDE",
  "proprietary_name": "Nateglinide",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA205248",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Nateglinide",
  "start_marketing_date": "20161027",
  "active_numerator_strength": "60"
}

Related drugs

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