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United States · US · US:70710-1986_dac30601-b2bf-4ec1-bbee-dcf022990efd

Sitagliptin and metformin hydrochloride

Orange BookUNIISPLATC A10BA

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

Identification

ManufacturerZydus Pharmaceuticals (USA) Inc.
CountryUS (United States)
ATC codeA10BA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7071019866
    60 TABLET, FILM COATED in 1 BOTTLE (70710-1986-6)
  • ndc11
    7071019868
    180 TABLET, FILM COATED in 1 BOTTLE (70710-1986-8)

Annotations

UNII (FDA Substance ID)
786Z46389E
METFORMIN HYDROCHLORIDE
RxCUI 235743
Orange Book
N216743
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "786Z46389E",
    "rxcui": "235743",
    "inchikey": "OETHQSJEHLVLGH-UHFFFAOYSA-N",
    "display_name": "METFORMIN HYDROCHLORIDE",
    "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": "70710-1986_dac30601-b2bf-4ec1-bbee-dcf022990efd",
  "productndc": "70710-1986",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "216743",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "500MG;50MG",
        "product_no": "001",
        "approval_date": "Nov 3, 2023"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "1GM;50MG",
        "product_no": "002",
        "approval_date": "Nov 3, 2023"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METFORMIN HYDROCHLORIDE; SITAGLIPTIN",
  "proprietary_name": "Sitagliptin and metformin hydrochloride",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA216743",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Sitagliptin and Metformin Hydrochloride",
  "start_marketing_date": "20240314",
  "active_numerator_strength": "500; 50"
}

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