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United States · US · US:43598-618_4e06c7a2-2e47-46dd-6637-03dddb2ef8c9

Saxagliptin and Metformin Hydrochloride

Orange BookUNIISPLATC A10BA

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

Identification

ManufacturerDr.Reddys Laboratories Inc
CountryUS (United States)
ATC codeA10BA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4359861860
    60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (43598-618-60)

Annotations

UNII (FDA Substance ID)
786Z46389E
METFORMIN HYDROCHLORIDE
RxCUI 235743
Orange Book
A207678
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": "43598-618_4e06c7a2-2e47-46dd-6637-03dddb2ef8c9",
  "productndc": "43598-618",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "207678",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG;EQ 5MG BASE",
        "product_no": "001",
        "approval_date": "Aug 9, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1GM;EQ 2.5MG BASE",
        "product_no": "002",
        "approval_date": "Aug 9, 2023"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "1GM;EQ 5MG BASE",
        "product_no": "003",
        "approval_date": "Aug 9, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METFORMIN HYDROCHLORIDE; SAXAGLIPTIN",
  "proprietary_name": "Saxagliptin and Metformin Hydrochloride",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA207678",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Saxagliptin and Metformin Hydrochloride",
  "start_marketing_date": "20230809",
  "active_numerator_strength": "1000; 2.5"
}

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