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United States · US · US:70121-2537_9a91921e-6c03-429b-94b5-6d885f3fe364
leuprolide acetate
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals LLC
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1170121253761 KIT in 1 CARTON (70121-2537-6) * 1 VIAL, MULTI-DOSE in 1 CARTON (70121-1695-2) / 2.8 mL in 1 VIAL, MULTI-DOSE * 1 mL in 1 PACKET (70121-2538-9)
Annotations
Orange Book
A215336
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": "SUBCUTANEOUS",
"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": "70121-2537_9a91921e-6c03-429b-94b5-6d885f3fe364",
"productndc": "70121-2537",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "215336",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "14MG/2.8ML (1MG/0.2ML)",
"product_no": "001",
"approval_date": "Oct 28, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "leuprolide acetate",
"active_ingred_unit": null,
"application_number": "ANDA215336",
"marketing_category": "ANDA",
"nonproprietary_name": "leuprolide acetate",
"start_marketing_date": "20221107",
"active_numerator_strength": null
}Access this data programmatically
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