GLATIRAMER ACETATE

Orange BookUNIISPLATC L03AX13

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

Identification

ManufacturerZydus Pharmaceuticals USA Inc.

CountryUS (United States)

ATC codeL03AX13

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7071015496
12 BLISTER PACK in 1 CARTON (70710-1549-6) / 1 SYRINGE in 1 BLISTER PACK / 1 mL in 1 SYRINGE (70710-1549-2)

Annotations

UNII (FDA Substance ID)

5M691HL4BO

GLATIRAMER ACETATE

RxCUI 84375

Orange Book

A208468

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": "70710-1549_f7c61e5d-41a8-4a49-bc8e-4a00713f2a3e",
  "productndc": "70710-1549",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "208468",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "20MG/ML",
        "product_no": "001",
        "approval_date": "May 7, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "40MG/ML",
        "product_no": "002",
        "approval_date": "May 7, 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": "ANDA208468",
  "marketing_category": "ANDA",
  "nonproprietary_name": "glatiramer acetate",
  "start_marketing_date": "20251110",
  "active_numerator_strength": "40"
}

Related drugs

Other records sharing ATC code L03AX13.

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