BACLOFEN

Orange BookUNIISPLATC M03BX01

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

Identification

ManufacturerAsclemed USA, Inc.

CountryUS (United States)

ATC codeM03BX01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 7

ndc11
7642035700
1000 TABLET in 1 BOTTLE (76420-357-00)
ndc11
7642035701
100 TABLET in 1 BOTTLE (76420-357-01)
ndc11
7642035705
500 TABLET in 1 BOTTLE (76420-357-05)
ndc11
7642035712
120 TABLET in 1 BOTTLE (76420-357-12)
ndc11
7642035730
30 TABLET in 1 BOTTLE (76420-357-30)
ndc11
7642035760
60 TABLET in 1 BOTTLE (76420-357-60)
ndc11
7642035790
90 TABLET in 1 BOTTLE (76420-357-90)

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": "76420-357_3c3b62bc-64f9-f0cb-e063-6394a90a4a92",
  "productndc": "76420-357",
  "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

Other records sharing ATC code M03BX01.

Access this data programmatically

Query BACLOFEN and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs