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United States · US · US:65862-672_54d938ac-ebf2-49d0-8056-f65d8aadfb98

Repaglinide

Orange BookUNIISPLATC A10BX02

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

Identification

ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeA10BX02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    6586267201
    100 TABLET in 1 BOTTLE (65862-672-01)
  • ndc11
    6586267205
    500 TABLET in 1 BOTTLE (65862-672-05)
  • ndc11
    6586267299
    1000 TABLET in 1 BOTTLE (65862-672-99)

Annotations

UNII (FDA Substance ID)
668Z8C33LU
REPAGLINIDE
RxCUI 73044
Orange Book
A203820
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "668Z8C33LU",
    "rxcui": "73044",
    "inchikey": "FAEKWTJYAYMJKF-QHCPKHFHSA-N",
    "display_name": "REPAGLINIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "6ae28683-28cc-408e-90f9-6a3dddfc668d": {
      "match": "brand_token",
      "title": "REPAGLINIDE TABLET [BRYANT RANCH PREPACK]",
      "spl_version": "100",
      "published_date": "2025-11-17"
    }
  },
  "productid": "65862-672_54d938ac-ebf2-49d0-8056-f65d8aadfb98",
  "productndc": "65862-672",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "203820",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.5MG",
        "product_no": "001",
        "approval_date": "Jan 22, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "002",
        "approval_date": "Jan 22, 2014"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "003",
        "approval_date": "Jan 22, 2014"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "REPAGLINIDE",
  "proprietary_name": "Repaglinide",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA203820",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Repaglinide",
  "start_marketing_date": "20140122",
  "active_numerator_strength": "2"
}

Related drugs

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