METFORMIN HYDROCHLORIDE

Orange BookUNIISPLATC A10BA02

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

Identification

ManufacturerMarlex Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeA10BA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 8

ndc11
1013582305
500 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-823-05)
ndc11
1013582310
1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-823-10)
ndc11
1013582330
30 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-823-30)
ndc11
1013582332
180 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-823-32)
ndc11
1013582333
360 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-823-33)
ndc11
1013582360
60 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-823-60)
ndc11
1013582362
120 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-823-62)
ndc11
1013582390
90 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-823-90)

Annotations

UNII (FDA Substance ID)

786Z46389E

METFORMIN HYDROCHLORIDE

RxCUI 235743

Orange Book

A202306

AB1AB

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": "10135-823_3e9d939c-6815-c5db-e063-6394a90ac9c2",
  "productndc": "10135-823",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "202306",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "500MG",
        "product_no": "001",
        "approval_date": "Feb 23, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "750MG",
        "product_no": "002",
        "approval_date": "Feb 23, 2017"
      }
    ],
    "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": "ANDA202306",
  "marketing_category": "ANDA",
  "nonproprietary_name": "METFORMIN HYDROCHLORIDE",
  "start_marketing_date": "20250801",
  "active_numerator_strength": "500"
}

Related drugs

Other records sharing ATC code A10BA02.

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