Metformin Hydrochloride

Orange BookUNIISPLATC A10BA02

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

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC codeA10BA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 10

ndc11
7133531320
25 TABLET, FILM COATED in 1 BOTTLE (71335-3132-0)
ndc11
7133531321
30 TABLET, FILM COATED in 1 BOTTLE (71335-3132-1)
ndc11
7133531322
60 TABLET, FILM COATED in 1 BOTTLE (71335-3132-2)
ndc11
7133531323
100 TABLET, FILM COATED in 1 BOTTLE (71335-3132-3)
ndc11
7133531324
120 TABLET, FILM COATED in 1 BOTTLE (71335-3132-4)
ndc11
7133531325
90 TABLET, FILM COATED in 1 BOTTLE (71335-3132-5)
ndc11
7133531326
28 TABLET, FILM COATED in 1 BOTTLE (71335-3132-6)
ndc11
7133531327
56 TABLET, FILM COATED in 1 BOTTLE (71335-3132-7)
ndc11
7133531328
180 TABLET, FILM COATED in 1 BOTTLE (71335-3132-8)
ndc11
7133531329
10 TABLET, FILM COATED in 1 BOTTLE (71335-3132-9)

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": "71335-3132_c3ee031e-9eed-4237-8db2-ca4570b66cfa",
  "productndc": "71335-3132",
  "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": "500"
}

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