Baclofen

Orange BookUNIISPLATC M03BX01

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

Identification

ManufacturerAmerican Health Packaging

CountryUS (United States)

ATC codeM03BX01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6068780465
50 BLISTER PACK in 1 CARTON (60687-804-65) / 1 TABLET in 1 BLISTER PACK (60687-804-11)

Annotations

UNII (FDA Substance ID)

H789N3FKE8

BACLOFEN

RxCUI 1292

Orange Book

A211659

ABABABAB

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": "60687-804_3b8a78f0-cf6e-1adb-e063-6294a90a55e6",
  "productndc": "60687-804",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "211659",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Nov 23, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "002",
        "approval_date": "Nov 23, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "003",
        "approval_date": "Apr 17, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "15MG",
        "product_no": "004",
        "approval_date": "Feb 13, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BACLOFEN",
  "proprietary_name": "Baclofen",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA211659",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Baclofen",
  "start_marketing_date": "20240526",
  "active_numerator_strength": "5"
}

Related drugs

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