ELIGARD

Orange BookSPL

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

Identification

ManufacturerTOLMAR Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6293530330
1 KIT in 1 CARTON (62935-303-30) * .5 mL in 1 SYRINGE (62935-305-29) * .5 mL in 1 SYRINGE (62935-304-30)

Annotations

Orange Book

N021488

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": "SUBCUTANEOUS",
  "spl_meta": {
    "b7b679a9-6823-4ef8-8d31-3ab5058ffcfc": {
      "match": "brand_token",
      "title": "ELIGARD (LEUPROLIDE ACETATE) INJECTION, SUSPENSION, EXTENDED RELEASE [TOLMAR INC.]",
      "spl_version": "19",
      "published_date": "2026-05-11"
    }
  },
  "productid": "62935-303_2bea4c81-66a2-4817-9440-5f5da8dea04a",
  "productndc": "62935-303",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "021488",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "30MG",
        "product_no": "001",
        "approval_date": "Feb 13, 2003"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "ELIGARD",
  "active_ingred_unit": null,
  "application_number": "NDA021488",
  "marketing_category": "NDA",
  "nonproprietary_name": "Leuprolide Acetate",
  "start_marketing_date": "20030226",
  "active_numerator_strength": null
}

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