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
6586201001
100 TABLET, FILM COATED in 1 BOTTLE (65862-010-01)
ndc11
6586201005
500 TABLET, FILM COATED in 1 BOTTLE (65862-010-05)
ndc11
6586201033
300 TABLET, FILM COATED in 1 BOTTLE (65862-010-33)
ndc11
6586201046
2000 TABLET, FILM COATED in 1 BOTTLE (65862-010-46)
ndc11
6586201050
50 TABLET, FILM COATED in 1 BOTTLE (65862-010-50)
ndc11
6586201060
60 TABLET, FILM COATED in 1 BOTTLE (65862-010-60)
ndc11
6586201090
90 TABLET, FILM COATED in 1 BOTTLE (65862-010-90)
ndc11
6586201099
1000 TABLET, FILM COATED in 1 BOTTLE (65862-010-99)

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": "65862-010_1c59d7bc-6118-4707-80c0-886ac00bab09",
  "productndc": "65862-010",
  "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": "20050114",
  "active_numerator_strength": "1000"
}

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