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United States · US · US:60505-3659_15cfffcf-3241-3e53-1f1e-ad300900662e

Sitagliptin and Metformin Hydrochloride

Orange BookUNIISPLATC A10BA

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

Identification

ManufacturerApotex Corp.
CountryUS (United States)
ATC codeA10BA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6050536596
    60 TABLET, FILM COATED in 1 BOTTLE (60505-3659-6)
  • ndc11
    6050536597
    180 TABLET, FILM COATED in 1 BOTTLE (60505-3659-7)

Annotations

UNII (FDA Substance ID)
786Z46389E
METFORMIN HYDROCHLORIDE
RxCUI 235743
Orange Book
A202426
ABAB
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": "60505-3659_15cfffcf-3241-3e53-1f1e-ad300900662e",
  "productndc": "60505-3659",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "202426",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG;EQ 50MG BASE",
        "product_no": "001",
        "approval_date": "Apr 30, 2026"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1GM;EQ 50MG BASE",
        "product_no": "002",
        "approval_date": "Apr 30, 2026"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE",
  "proprietary_name": "Sitagliptin and Metformin Hydrochloride",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA202426",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Sitagliptin and Metformin Hydrochloride",
  "start_marketing_date": "20260528",
  "active_numerator_strength": "1000; 50"
}

Related drugs

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