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United States · US · US:64764-250_225103de-a3f2-47ee-bebb-4aa24b16aab4

Nesina

Orange BookUNIISPLATC A10BH04

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

Identification

ManufacturerTakeda Pharmaceuticals America, Inc.
CountryUS (United States)
ATC codeA10BH04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    6476425002
    4 CARTON in 1 TRAY (64764-250-02) / 1 BLISTER PACK in 1 CARTON / 7 TABLET, FILM COATED in 1 BLISTER PACK
  • ndc11
    6476425030
    30 TABLET, FILM COATED in 1 BOTTLE (64764-250-30)
  • ndc11
    6476425050
    500 TABLET, FILM COATED in 1 BOTTLE (64764-250-50)
  • ndc11
    6476425090
    90 TABLET, FILM COATED in 1 BOTTLE (64764-250-90)

Annotations

UNII (FDA Substance ID)
EEN99869SC
ALOGLIPTIN BENZOATE
RxCUI 1368000
Orange Book
N022271
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "EEN99869SC",
    "rxcui": "1368000",
    "inchikey": "KEJICOXJTRHYAK-XFULWGLBSA-N",
    "display_name": "ALOGLIPTIN BENZOATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "a3768c7e-aa4c-44d3-bc53-43bb7346c0b0": {
      "match": "brand_token",
      "title": "NESINA (ALOGLIPTIN) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]",
      "spl_version": "22",
      "published_date": "2025-03-24"
    }
  },
  "productid": "64764-250_225103de-a3f2-47ee-bebb-4aa24b16aab4",
  "productndc": "64764-250",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "022271",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 6.25MG BASE",
        "product_no": "001",
        "approval_date": "Jan 25, 2013"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 12.5MG BASE",
        "product_no": "002",
        "approval_date": "Jan 25, 2013"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 25MG BASE",
        "product_no": "003",
        "approval_date": "Jan 25, 2013"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ALOGLIPTIN BENZOATE",
  "proprietary_name": "Nesina",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA022271",
  "marketing_category": "NDA",
  "nonproprietary_name": "alogliptin",
  "start_marketing_date": "20130125",
  "active_numerator_strength": "25"
}

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