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United States · US · US:70771-1792_f5e22251-a49c-409a-8687-a15b20c13906

Sitagliptin

Orange BookUNIISPLATC A10BH01

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

Identification

ManufacturerZydus Lifesciences Limited
CountryUS (United States)
ATC codeA10BH01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7077117923
    30 TABLET in 1 BOTTLE (70771-1792-3)
  • ndc11
    7077117929
    90 TABLET in 1 BOTTLE (70771-1792-9)

Annotations

UNII (FDA Substance ID)
QFP0P1DV7Z
SITAGLIPTIN
RxCUI 593411
Orange Book
N211566
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "QFP0P1DV7Z",
    "rxcui": "593411",
    "inchikey": "MFFMDFFZMYYVKS-SECBINFHSA-N",
    "display_name": "SITAGLIPTIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "5fa5aa67-455e-4ac6-864d-268a91286432": {
      "match": "brand_token",
      "title": "SITAGLIPTIN TABLET, FILM COATED [TEVA PHARMACEUTICALS, INC.]",
      "spl_version": "1",
      "published_date": "2026-06-01"
    }
  },
  "productid": "70771-1792_f5e22251-a49c-409a-8687-a15b20c13906",
  "productndc": "70771-1792",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "211566",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Oct 18, 2023"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "Oct 18, 2023"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "100MG",
        "product_no": "003",
        "approval_date": "Oct 18, 2023"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SITAGLIPTIN",
  "proprietary_name": "Sitagliptin",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA211566",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Sitagliptin",
  "start_marketing_date": "20231130",
  "active_numerator_strength": "100"
}

Related drugs

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