Glatiramer Acetate

Orange BookUNIISPLATC L03AX13

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

Identification

ManufacturerUPSHER-SMITH LABORATORIES, LLC

CountryUS (United States)

ATC codeL03AX13

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0832608512
12 SYRINGE, GLASS in 1 CARTON (0832-6085-12) / 1 mL in 1 SYRINGE, GLASS (0832-6085-89)

Annotations

UNII (FDA Substance ID)

5M691HL4BO

GLATIRAMER ACETATE

RxCUI 84375

Orange Book

A214741

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": {
    "7a573ffb-5dd7-43b7-8633-c69f303b1bbf": {
      "match": "brand_token",
      "title": "GLATIRAMER ACETATE INJECTION, SOLUTION [AJENAT PHARMACEUTICALS LLC]",
      "spl_version": "2",
      "published_date": "2026-04-02"
    }
  },
  "productid": "0832-6085_991aa361-3f99-42cd-948b-5b1271b346c5",
  "productndc": "0832-6085",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "214741",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "20MG/ML",
        "product_no": "001",
        "approval_date": "Dec 31, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "40MG/ML",
        "product_no": "002",
        "approval_date": "Dec 31, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GLATIRAMER ACETATE",
  "proprietary_name": "Glatiramer Acetate",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA214741",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Glatiramer Acetate Injection",
  "start_marketing_date": "20260123",
  "active_numerator_strength": "40"
}

Related drugs

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