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United States · US · US:71610-300_a8ff5402-3a49-4f04-9868-f8b2dff3aa99

Alogliptin

Orange BookUNIISPLATC A10BH04

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

Identification

ManufacturerAphena Pharma Solutions - Tennessee, LLC
CountryUS (United States)
ATC codeA10BH04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    7161030009
    9000 TABLET, FILM COATED in 1 BOTTLE (71610-300-09)
  • ndc11
    7161030018
    3000 TABLET, FILM COATED in 1 BOTTLE (71610-300-18)
  • ndc11
    7161030060
    90 TABLET, FILM COATED in 1 BOTTLE (71610-300-60)

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": {
    "642b1e90-701e-42f2-bac6-a4918738e2c9": {
      "match": "brand_token",
      "title": "ALOGLIPTIN AND PIOGLITAZONE (ALOGLIPTIN BENZOATE AND PIOGLITAZONE HYDROCHLORIDE) TABLET, FILM COATED [PADAGIS ISRAEL PHARMACEUTICALS LTD]",
      "spl_version": "11",
      "published_date": "2025-08-11"
    }
  },
  "productid": "71610-300_a8ff5402-3a49-4f04-9868-f8b2dff3aa99",
  "productndc": "71610-300",
  "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": "Alogliptin",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA022271",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Alogliptin",
  "start_marketing_date": "20160408",
  "active_numerator_strength": "25"
}

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