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United States · US · US:62935-461_58cff066-4345-4624-8868-4c232a051a5d
Eligard
Orange BookUNIISPLATC L02AE02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTOLMAR Inc.
CountryUS (United States)
ATC codeL02AE02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1162935461501 SYRINGE in 1 CARTON (62935-461-50) / .375 mL in 1 SYRINGE
Annotations
UNII (FDA Substance ID)
37JNS02E7V
LEUPROLIDE ACETATE
RxCUI 203217
Orange Book
N021731
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "37JNS02E7V",
"rxcui": "203217",
"inchikey": "RGLRXNKKBLIBQS-XNHQSDQCSA-N",
"display_name": "LEUPROLIDE ACETATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"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": "62935-461_58cff066-4345-4624-8868-4c232a051a5d",
"productndc": "62935-461",
"dosage_form": "INJECTION, SUSPENSION, EXTENDED RELEASE",
"orange_book": {
"appl_no": "021731",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "45MG",
"product_no": "001",
"approval_date": "Dec 14, 2004"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LEUPROLIDE ACETATE",
"proprietary_name": "Eligard",
"active_ingred_unit": "mg/.375mL",
"application_number": "NDA021731",
"marketing_category": "NDA",
"nonproprietary_name": "Leuprolide acetate",
"start_marketing_date": "20230306",
"active_numerator_strength": "45"
}Related drugs
Other records sharing ATC code L02AE02.
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