Metformin Hydrochloride Oral Solution

Orange BookUNIISPLATC A10BA02

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

Identification

ManufacturerTRUPHARMA, LLC

CountryUS (United States)

ATC codeA10BA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5281782150
5 TRAY in 1 CASE (52817-821-50) / 10 CUP, UNIT-DOSE in 1 TRAY / 8.5 mL in 1 CUP, UNIT-DOSE

Annotations

UNII (FDA Substance ID)

786Z46389E

METFORMIN HYDROCHLORIDE

RxCUI 235743

Orange Book

A211309

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": "52817-821_2a4320c6-8080-9ddc-e063-6294a90aa921",
  "productndc": "52817-821",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "211309",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG/5ML",
        "product_no": "001",
        "approval_date": "Mar 3, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METFORMIN HYDROCHLORIDE",
  "proprietary_name": "Metformin Hydrochloride Oral Solution",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA211309",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Metformin Hydrochloride",
  "start_marketing_date": "20220125",
  "active_numerator_strength": "500"
}

Related drugs

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