Baclofen

Orange BookUNIISPLATC M03BX01

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

Identification

ManufacturerProficient Rx LP

CountryUS (United States)

ATC codeM03BX01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
6318731320
20 TABLET in 1 BOTTLE, PLASTIC (63187-313-20)
ndc11
6318731330
30 TABLET in 1 BOTTLE, PLASTIC (63187-313-30)
ndc11
6318731360
60 TABLET in 1 BOTTLE, PLASTIC (63187-313-60)
ndc11
6318731372
120 TABLET in 1 BOTTLE, PLASTIC (63187-313-72)
ndc11
6318731378
180 TABLET in 1 BOTTLE, PLASTIC (63187-313-78)
ndc11
6318731390
90 TABLET in 1 BOTTLE, PLASTIC (63187-313-90)

Annotations

UNII (FDA Substance ID)

H789N3FKE8

BACLOFEN

RxCUI 1292

Orange Book

A077241

ABABAB

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": "63187-313_83a0b967-118f-4459-ad38-1ec6a769dcc4",
  "productndc": "63187-313",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "077241",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "001",
        "approval_date": "Dec 20, 2005"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Jul 6, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "003",
        "approval_date": "Sep 22, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BACLOFEN",
  "proprietary_name": "Baclofen",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA077241",
  "marketing_category": "ANDA",
  "nonproprietary_name": "baclofen",
  "start_marketing_date": "20051201",
  "active_numerator_strength": "10"
}

Related drugs

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