Metformin Hydrochloride

Orange BookUNIISPLATC A10BA02

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

Identification

ManufacturerREMEDYREPACK INC.

CountryUS (United States)

ATC codeA10BA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
7051831010
30 TABLET in 1 BLISTER PACK (70518-3101-0)
ndc11
7051831011
180 TABLET in 1 BOTTLE, PLASTIC (70518-3101-1)
ndc11
7051831012
90 TABLET in 1 BOTTLE, PLASTIC (70518-3101-2)
ndc11
7051831014
30 TABLET in 1 BLISTER PACK (70518-3101-4)
ndc11
7051831015
60 TABLET in 1 BOTTLE, PLASTIC (70518-3101-5)
ndc11
7051831016
100 TABLET in 1 BOTTLE, PLASTIC (70518-3101-6)

Annotations

UNII (FDA Substance ID)

786Z46389E

METFORMIN HYDROCHLORIDE

RxCUI 235743

Orange Book

A090564

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": "70518-3101_4e918280-a0c6-19a7-e063-6394a90a48e3",
  "productndc": "70518-3101",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "090564",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "001",
        "approval_date": "Apr 22, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "850MG",
        "product_no": "002",
        "approval_date": "Apr 22, 2010"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "1GM",
        "product_no": "003",
        "approval_date": "Apr 22, 2010"
      }
    ],
    "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": "ANDA090564",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Metformin Hydrochloride",
  "start_marketing_date": "20210524",
  "active_numerator_strength": "1000"
}

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