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United States · US · US:70771-1687_ebf565fd-e894-45ad-8b0b-8b94bdf375d1
LEUPROLIDE ACETATE
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Lifesciences Limited
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1170771168731 KIT in 1 CARTON (70771-1687-3) * 1 VIAL, MULTI-DOSE in 1 CARTON (70771-1686-1) / 2.8 mL in 1 VIAL, MULTI-DOSE * 1 mL in 1 PACKET (70771-1765-8)
Annotations
Orange Book
A215826
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": null,
"spl_meta": {
"35634415-000f-47db-9bd7-9e16eef3f02e": {
"match": "brand_token",
"title": "LEUPROLIDE ACETATE (LEUPROLIDE ACETATE) KIT [ZYDUS PHARMACEUTICALS USA INC.]",
"spl_version": "6",
"published_date": "2026-05-28"
}
},
"productid": "70771-1687_ebf565fd-e894-45ad-8b0b-8b94bdf375d1",
"productndc": "70771-1687",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "215826",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "14MG/2.8ML (1MG/0.2ML)",
"product_no": "001",
"approval_date": "Nov 13, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "LEUPROLIDE ACETATE",
"active_ingred_unit": null,
"application_number": "ANDA215826",
"marketing_category": "ANDA",
"nonproprietary_name": "LEUPROLIDE ACETATE",
"start_marketing_date": "20260108",
"active_numerator_strength": null
}Access this data programmatically
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