Saxagliptin

Orange BookUNIISPLATC A10BH03

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

Identification

ManufacturerAurobindo Pharma Limited

CountryUS (United States)

ATC codeA10BH03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
6586282501
100 TABLET, FILM COATED in 1 BOTTLE (65862-825-01)
ndc11
6586282505
500 TABLET, FILM COATED in 1 BOTTLE (65862-825-05)
ndc11
6586282530
30 TABLET, FILM COATED in 1 BOTTLE (65862-825-30)
ndc11
6586282590
90 TABLET, FILM COATED in 1 BOTTLE (65862-825-90)

Annotations

UNII (FDA Substance ID)

Z8J84YIX6L

SAXAGLIPTIN HYDROCHLORIDE

RxCUI 1043560

Orange Book

A205972

ABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "Z8J84YIX6L",
    "rxcui": "1043560",
    "inchikey": "TUAZNHHHYVBVBR-NHKADLRUSA-N",
    "display_name": "SAXAGLIPTIN 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": "65862-825_ac9f5784-0c62-42f2-bc34-4cef2486b7f7",
  "productndc": "65862-825",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "205972",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2.5MG BASE",
        "product_no": "001",
        "approval_date": "Jul 31, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "002",
        "approval_date": "Jul 31, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SAXAGLIPTIN HYDROCHLORIDE",
  "proprietary_name": "Saxagliptin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA205972",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Saxagliptin",
  "start_marketing_date": "20230731",
  "active_numerator_strength": "2.5"
}

Related drugs

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