Sitagliptin and Metformin Hydrochloride

Orange BookUNIISPLATC A10BA

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

Identification

ManufacturerSandoz Inc

CountryUS (United States)

ATC codeA10BA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
0781580105
500 TABLET, FILM COATED in 1 BOTTLE (0781-5801-05)
ndc11
0781580160
60 TABLET, FILM COATED in 1 BOTTLE (0781-5801-60)
ndc11
0781580171
180 TABLET, FILM COATED in 1 BOTTLE (0781-5801-71)

Annotations

UNII (FDA Substance ID)

786Z46389E

METFORMIN HYDROCHLORIDE

RxCUI 235743

Orange Book

A202388

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": "0781-5801_a0fcdc08-0afc-4912-a126-3efea6bc8c61",
  "productndc": "0781-5801",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "202388",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG;EQ 50MG BASE",
        "product_no": "001",
        "approval_date": "Dec 2, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1GM;EQ 50MG BASE",
        "product_no": "002",
        "approval_date": "Dec 2, 2025"
      }
    ],
    "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": "ANDA202388",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Sitagliptin and Metformin Hydrochloride",
  "start_marketing_date": "20251202",
  "active_numerator_strength": "500; 50"
}

Related drugs

Other records sharing ATC code A10BA.

Access this data programmatically

Query Sitagliptin and Metformin Hydrochloride and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs