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United States · US · US:72603-810_19426809-2230-4ebf-a29a-40e25326a943

Repaglinide

Orange BookUNIISPLATC A10BX02

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

Identification

ManufacturerNorthStar RxLLC
CountryUS (United States)
ATC codeA10BX02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7260381001
    100 TABLET in 1 BOTTLE (72603-810-01)

Annotations

UNII (FDA Substance ID)
668Z8C33LU
REPAGLINIDE
RxCUI 73044
Orange Book
A207209
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": "72603-810_19426809-2230-4ebf-a29a-40e25326a943",
  "productndc": "72603-810",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "207209",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.5MG",
        "product_no": "001",
        "approval_date": "Mar 22, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "002",
        "approval_date": "Mar 22, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "003",
        "approval_date": "Mar 22, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "REPAGLINIDE",
  "proprietary_name": "Repaglinide",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA207209",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Repaglinide",
  "start_marketing_date": "20250408",
  "active_numerator_strength": ".5"
}

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