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United States · US · US:69448-023_4b1ad850-61b1-d516-e063-6394a90aeea8
CAMCEVI
Orange BookUNIISPLATC L02AE02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAccord BioPharma, Inc.
CountryUS (United States)
ATC codeL02AE02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1169448023631 SYRINGE in 1 CARTON (69448-023-63) / .37 g in 1 SYRINGE
Annotations
UNII (FDA Substance ID)
8E3C3C493W
LEUPROLIDE MESYLATE
RxCUI 2595041
Orange Book
N211488
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "8E3C3C493W",
"rxcui": "2595041",
"inchikey": "MTNPUUYAPMTHTE-VKSXBADUSA-N",
"display_name": "LEUPROLIDE MESYLATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "SUBCUTANEOUS",
"spl_meta": {
"cbff25e5-6fe8-4e44-b10a-8397b3349905": {
"match": "brand_token",
"title": "CAMCEVI (LEUPROLIDE) INJECTION, EMULSION [ACCORD BIOPHARMA, INC.]",
"spl_version": "8",
"published_date": "2026-02-19"
}
},
"productid": "69448-023_4b1ad850-61b1-d516-e063-6394a90aeea8",
"productndc": "69448-023",
"dosage_form": "INJECTION, EMULSION",
"orange_book": {
"appl_no": "211488",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 42MG BASE",
"product_no": "001",
"approval_date": "May 25, 2021"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LEUPROLIDE MESYLATE",
"proprietary_name": "CAMCEVI",
"active_ingred_unit": "mg/.37g",
"application_number": "NDA211488",
"marketing_category": "NDA",
"nonproprietary_name": "LEUPROLIDE",
"start_marketing_date": "20250519",
"active_numerator_strength": "42"
}Related drugs
Other records sharing ATC code L02AE02.
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