Metformin HCl

Orange BookUNIISPLATC A10BA02

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

Identification

ManufacturerTIME CAP LABORATORIES, INC

CountryUS (United States)

ATC codeA10BA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
4948362201
100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49483-622-01)
ndc11
4948362210
1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49483-622-10)
ndc11
4948362250
500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49483-622-50)
ndc11
4948362281
180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49483-622-81)

Annotations

UNII (FDA Substance ID)

786Z46389E

METFORMIN HYDROCHLORIDE

RxCUI 235743

Orange Book

A090888

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": "49483-622_2dc48b61-581f-fe5c-e063-6394a90aa557",
  "productndc": "49483-622",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "090888",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "001",
        "approval_date": "Mar 12, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "850MG",
        "product_no": "002",
        "approval_date": "Mar 12, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1GM",
        "product_no": "003",
        "approval_date": "Mar 12, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METFORMIN HYDROCHLORIDE",
  "proprietary_name": "Metformin HCl",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA090888",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Metformin HCl",
  "start_marketing_date": "20161114",
  "active_numerator_strength": "500"
}

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