Back to search
🇺🇸

United States · US · US:68382-721_061a2260-2804-4753-b443-17943eca74dd

Nateglinide

Orange BookUNIISPLATC A10BX03

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerZydus Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeA10BX03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 6

  • ndc11
    6838272101
    100 TABLET, FILM COATED in 1 BOTTLE (68382-721-01)
  • ndc11
    6838272105
    500 TABLET, FILM COATED in 1 BOTTLE (68382-721-05)
  • ndc11
    6838272106
    30 TABLET, FILM COATED in 1 BOTTLE (68382-721-06)
  • ndc11
    6838272110
    1000 TABLET, FILM COATED in 1 BOTTLE (68382-721-10)
  • ndc11
    6838272116
    90 TABLET, FILM COATED in 1 BOTTLE (68382-721-16)
  • ndc11
    6838272177
    10 BLISTER PACK in 1 CARTON (68382-721-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK

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": "68382-721_061a2260-2804-4753-b443-17943eca74dd",
  "productndc": "68382-721",
  "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

Other records sharing ATC code A10BX03.

Access this data programmatically

Query Nateglinide and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.