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United States · US · US:69238-2794_eb09c632-ad0b-4dc9-b7a6-3189ba25f77e
Naltrexone
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals NY LLC
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1169238279411 KIT in 1 CARTON (69238-2794-1) * 5 mL in 1 VIAL, GLASS (69238-2792-1) * 4 mL in 1 VIAL, GLASS (69238-2793-1)
Annotations
Orange Book
N021897
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": null,
"spl_meta": {
"fa0b0881-97f3-4ca2-bc15-0954293081db": {
"match": "brand_token",
"title": "NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]",
"spl_version": "13",
"published_date": "2026-05-20"
}
},
"productid": "69238-2794_eb09c632-ad0b-4dc9-b7a6-3189ba25f77e",
"productndc": "69238-2794",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "021897",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "380MG/VIAL",
"product_no": "001",
"approval_date": "Apr 13, 2006"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "Naltrexone",
"active_ingred_unit": null,
"application_number": "NDA021897",
"marketing_category": "NDA",
"nonproprietary_name": "Naltrexone",
"start_marketing_date": "20260501",
"active_numerator_strength": null
}Access this data programmatically
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