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United States · US · US:67544-671_ba0a7c8f-e018-4e0b-97df-8e5752eb03ad

Baclofen

UNIISPLATC M03BX01

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

Identification

ManufacturerAphena Pharma Solutions - Tennessee, LLC
CountryUS (United States)
ATC codeM03BX01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    6754467160
    90 TABLET in 1 BOTTLE, PLASTIC (67544-671-60)
  • ndc11
    6754467180
    180 TABLET in 1 BOTTLE, PLASTIC (67544-671-80)
  • ndc11
    6754467192
    270 TABLET in 1 BOTTLE, PLASTIC (67544-671-92)

Annotations

UNII (FDA Substance ID)
H789N3FKE8
BACLOFEN
RxCUI 1292
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "H789N3FKE8",
    "rxcui": "1292",
    "inchikey": "KPYSYYIEGFHWSV-UHFFFAOYSA-N",
    "display_name": "BACLOFEN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "e017a001-8cb1-4dd8-960e-c6d74005f57f": {
      "match": "brand_token",
      "title": "BACLOFEN TABLET [REMEDYREPACK INC.]",
      "spl_version": "1",
      "published_date": "2026-05-13"
    }
  },
  "productid": "67544-671_ba0a7c8f-e018-4e0b-97df-8e5752eb03ad",
  "productndc": "67544-671",
  "dosage_form": "TABLET",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BACLOFEN",
  "proprietary_name": "Baclofen",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA077156",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Baclofen",
  "start_marketing_date": "20050830",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code M03BX01.

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