BACLOFEN

Orange BookUNIISPLATC M03BX01

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

Identification

ManufacturerTruPharma LLC

CountryUS (United States)

ATC codeM03BX01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
5281732100
1000 TABLET in 1 BOTTLE (52817-321-00)
ndc11
5281732110
100 TABLET in 1 BOTTLE (52817-321-10)
ndc11
5281732150
500 TABLET in 1 BOTTLE (52817-321-50)

Annotations

UNII (FDA Substance ID)

H789N3FKE8

BACLOFEN

RxCUI 1292

Orange Book

A209102

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": "52817-321_1645f54e-2eed-bd9b-e063-6294a90a848b",
  "productndc": "52817-321",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "209102",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Nov 28, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Nov 28, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "003",
        "approval_date": "Nov 28, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "15MG",
        "product_no": "004",
        "approval_date": "Feb 5, 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": "ANDA209102",
  "marketing_category": "ANDA",
  "nonproprietary_name": "BACLOFEN",
  "start_marketing_date": "20180401",
  "active_numerator_strength": "20"
}

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