Metformin Hydrochloride

Orange BookUNIISPLATC A10BA02

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

Identification

ManufacturerAurobindo Pharma Limited

CountryUS (United States)

ATC codeA10BA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 8

ndc11
5965185501
100 TABLET, FILM COATED in 1 BOTTLE (59651-855-01)
ndc11
5965185505
500 TABLET, FILM COATED in 1 BOTTLE (59651-855-05)
ndc11
5965185526
2500 TABLET, FILM COATED in 1 BOTTLE (59651-855-26)
ndc11
5965185550
50 TABLET, FILM COATED in 1 BOTTLE (59651-855-50)
ndc11
5965185560
60 TABLET, FILM COATED in 1 BOTTLE (59651-855-60)
ndc11
5965185579
300 TABLET, FILM COATED in 1 BOTTLE (59651-855-79)
ndc11
5965185590
90 TABLET, FILM COATED in 1 BOTTLE (59651-855-90)
ndc11
5965185599
1000 TABLET, FILM COATED in 1 BOTTLE (59651-855-99)

Annotations

UNII (FDA Substance ID)

786Z46389E

METFORMIN HYDROCHLORIDE

RxCUI 235743

Orange Book

A077095

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": {
    "1cb2b2be-595c-4e72-8d2c-c1edc7f85682": {
      "match": "brand_token",
      "title": "METFORMIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]",
      "spl_version": "9",
      "published_date": "2026-06-01"
    }
  },
  "productid": "59651-855_0bfb57c0-6114-4734-a8d7-b78102e7f8eb",
  "productndc": "59651-855",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "077095",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "001",
        "approval_date": "Jan 14, 2005"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "850MG",
        "product_no": "002",
        "approval_date": "Jan 14, 2005"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1GM",
        "product_no": "003",
        "approval_date": "Jan 14, 2005"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METFORMIN HYDROCHLORIDE",
  "proprietary_name": "Metformin Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA077095",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Metformin Hydrochloride",
  "start_marketing_date": "20240329",
  "active_numerator_strength": "850"
}

Related drugs

Other records sharing ATC code A10BA02.

Access this data programmatically

Query 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