Copaxone

Orange BookUNIISPLATC L03AX13

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

Identification

ManufacturerTeva Neuroscience, Inc.

CountryUS (United States)

ATC codeL03AX13

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6854632506
6 BLISTER PACK in 1 CARTON (68546-325-06) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS
ndc11
6854632512
12 BLISTER PACK in 1 CARTON (68546-325-12) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS

Annotations

UNII (FDA Substance ID)

5M691HL4BO

GLATIRAMER ACETATE

RxCUI 84375

Orange Book

N020622

APAP

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "5M691HL4BO",
    "rxcui": "84375",
    "inchikey": null,
    "display_name": "GLATIRAMER ACETATE",
    "substance_type": "polymer",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBCUTANEOUS",
  "spl_meta": {
    "aa88f583-4f5f-433b-80b4-1f4c9fb28357": {
      "match": "brand_token",
      "title": "COPAXONE (GLATIRAMER ACETATE) INJECTION, SOLUTION [TEVA NEUROSCIENCE, INC.]",
      "spl_version": "35",
      "published_date": "2025-02-21"
    }
  },
  "productid": "68546-325_5a691b1f-367f-4635-a7d6-0111361a2dbb",
  "productndc": "68546-325",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "020622",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "20MG/VIAL",
        "product_no": "001",
        "approval_date": "Dec 20, 1996"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "20MG/ML",
        "product_no": "002",
        "approval_date": "Feb 12, 2002"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "40MG/ML",
        "product_no": "003",
        "approval_date": "Jan 28, 2014"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GLATIRAMER ACETATE",
  "proprietary_name": "Copaxone",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA020622",
  "marketing_category": "NDA",
  "nonproprietary_name": "Glatiramer Acetate",
  "start_marketing_date": "20140129",
  "active_numerator_strength": "40"
}

Related drugs

Other records sharing ATC code L03AX13.

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