ZITUVIMET XR

Orange BookUNIISPLATC A10BA

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerZydus Lifesciences Limited

CountryUS (United States)

ATC codeA10BA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7077118796
60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70771-1879-6)

Annotations

UNII (FDA Substance ID)

786Z46389E

METFORMIN HYDROCHLORIDE

RxCUI 235743

Orange Book

N216778

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": {
    "2f635b36-e86a-4e53-8eaf-589917b5f342": {
      "match": "brand_token",
      "title": "ZITUVIMET XR (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS USA INC.]",
      "spl_version": "2",
      "published_date": "2026-01-06"
    }
  },
  "productid": "70771-1879_853cf721-7c0c-42ed-9243-eb7cddd3574d",
  "productndc": "70771-1879",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "216778",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "500MG;50MG",
        "product_no": "001",
        "approval_date": "Jul 18, 2024"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "1GM;50MG",
        "product_no": "002",
        "approval_date": "Jul 18, 2024"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "1GM;100MG",
        "product_no": "003",
        "approval_date": "Jul 18, 2024"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METFORMIN HYDROCHLORIDE; SITAGLIPTIN",
  "proprietary_name": "ZITUVIMET XR",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA216778",
  "marketing_category": "NDA",
  "nonproprietary_name": "sitagliptin and metformin hydrochloride",
  "start_marketing_date": "20241031",
  "active_numerator_strength": "500; 50"
}

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