BACLOFEN

Orange BookUNIISPLATC M03BX01

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

Identification

ManufacturerNCS HealthCare of KY, LLC dba Vangard Labs

CountryUS (United States)

ATC codeM03BX01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
0615846605
15 TABLET in 1 BLISTER PACK (0615-8466-05)
ndc11
0615846639
30 TABLET in 1 BLISTER PACK (0615-8466-39)

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": "0615-8466_9c2e25e4-823f-4ac2-82f4-674049807af5",
  "productndc": "0615-8466",
  "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": "10"
}

Related drugs

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