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United States · US · US:0641-6217_2d52b3d7-dd93-47a3-95cf-7d4d50de5b18

ROBAXIN

Orange BookUNIISPLATC M03BA53

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

Identification

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

Packs · 2

  • ndc11
    0641621710
    10 VIAL in 1 CARTON (0641-6217-10) / 10 mL in 1 VIAL (0641-6217-01)
  • ndc11
    0641621725
    25 VIAL in 1 CARTON (0641-6217-25) / 10 mL in 1 VIAL (0641-6217-01)

Annotations

UNII (FDA Substance ID)
125OD7737X
METHOCARBAMOL
RxCUI 6845
Orange Book
N011790
AP
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": "INTRAMUSCULAR; INTRAVENOUS",
  "spl_meta": {
    "090a3d3d-92c3-4c30-a648-436461f81702": {
      "match": "brand_token",
      "title": "ROBAXIN (METHOCARBAMOL) INJECTION [HIKMA PHARMACEUTICALS USA INC.]",
      "spl_version": "8",
      "published_date": "2024-04-12"
    }
  },
  "productid": "0641-6217_2d52b3d7-dd93-47a3-95cf-7d4d50de5b18",
  "productndc": "0641-6217",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "011790",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "1GM/10ML (100MG/ML)",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METHOCARBAMOL",
  "proprietary_name": "ROBAXIN",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA011790",
  "marketing_category": "NDA",
  "nonproprietary_name": "methocarbamol",
  "start_marketing_date": "20171017",
  "active_numerator_strength": "100"
}

Related drugs

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