Saxagliptin and Metformin

Orange BookUNIISPLATC A10BA

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

Identification

ManufacturerMylan Pharmaceuticals Inc.

CountryUS (United States)

ATC codeA10BA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0378817691
60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-8176-91)

Annotations

UNII (FDA Substance ID)

786Z46389E

METFORMIN HYDROCHLORIDE

RxCUI 235743

Orange Book

A205981

ABABAB

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": {
    "65884427-4dde-63bb-a23f-36a7779c0a6b": {
      "match": "brand_token",
      "title": "SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [DR.REDDYS LABORATORIES INC]",
      "spl_version": "7",
      "published_date": "2026-05-20"
    }
  },
  "productid": "0378-8176_09385285-c5a1-444e-9c2e-64da50e2a508",
  "productndc": "0378-8176",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "205981",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG;EQ 5MG BASE",
        "product_no": "001",
        "approval_date": "Jul 31, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1GM;EQ 2.5MG BASE",
        "product_no": "002",
        "approval_date": "Jul 31, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1GM;EQ 5MG BASE",
        "product_no": "003",
        "approval_date": "Jul 31, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE DIHYDRATE",
  "proprietary_name": "Saxagliptin and Metformin",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA205981",
  "marketing_category": "ANDA",
  "nonproprietary_name": "saxagliptin and metformin",
  "start_marketing_date": "20230808",
  "active_numerator_strength": "1000; 2.5"
}

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