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United States · US · US:10135-722_441fa8ee-c4b7-d58f-e063-6394a90a3229

Methocarbamol Tablets, USP, 500 mg

Orange BookUNIISPLATC M03BA53

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerMarlex Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeM03BA53
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    1013572201
    100 TABLET, FILM COATED in 1 BOTTLE (10135-722-01)
  • ndc11
    1013572205
    500 TABLET, FILM COATED in 1 BOTTLE (10135-722-05)

Annotations

UNII (FDA Substance ID)
125OD7737X
METHOCARBAMOL
RxCUI 6845
Orange Book
A212623
AAAA
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "125OD7737X",
    "rxcui": "6845",
    "inchikey": "GNXFOGHNGIVQEH-UHFFFAOYSA-N",
    "display_name": "METHOCARBAMOL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "3212f121-9428-4186-8f00-accf08bca473": {
      "match": "brand_token",
      "title": "METHOCARBAMOL TABLET, FILM COATED [BRYANT RANCH PREPACK]",
      "spl_version": "7",
      "published_date": "2026-06-01"
    }
  },
  "productid": "10135-722_441fa8ee-c4b7-d58f-e063-6394a90a3229",
  "productndc": "10135-722",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "212623",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "500MG",
        "product_no": "001",
        "approval_date": "Apr 30, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "750MG",
        "product_no": "002",
        "approval_date": "Apr 30, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METHOCARBAMOL",
  "proprietary_name": "Methocarbamol Tablets, USP, 500 mg",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA212623",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Methocarbamol",
  "start_marketing_date": "20211209",
  "active_numerator_strength": "500"
}

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