Back to search
🇺🇸

United States · US · US:69528-701_4ce9560d-185c-1e28-e063-6294a90af77f

ATMEKSI

Orange BookUNIISPLATC M03BA53

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

Identification

ManufacturerRosemont Pharmaceuticals LLC
CountryUS (United States)
ATC codeM03BA53
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6952870105
    150 mL in 1 BOTTLE (69528-701-05)

Annotations

UNII (FDA Substance ID)
125OD7737X
METHOCARBAMOL
RxCUI 6845
Orange Book
N219843
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": {
    "62de7345-613b-4838-96e5-aceca3cea6b2": {
      "match": "brand_token",
      "title": "ATMEKSI (METHOCARBAMOL) SUSPENSION [ROSEMONT PHARMACEUTICALS LLC]",
      "spl_version": "3",
      "published_date": "2026-03-16"
    }
  },
  "productid": "69528-701_4ce9560d-185c-1e28-e063-6294a90af77f",
  "productndc": "69528-701",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "219843",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "750MG/5ML",
        "product_no": "001",
        "approval_date": "Jul 30, 2025"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METHOCARBAMOL",
  "proprietary_name": "ATMEKSI",
  "active_ingred_unit": "mg/5mL",
  "application_number": "NDA219843",
  "marketing_category": "NDA",
  "nonproprietary_name": "methocarbamol",
  "start_marketing_date": "20251222",
  "active_numerator_strength": "750"
}

Related drugs

Other records sharing ATC code M03BA53.

Access this data programmatically

Query ATMEKSI and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.