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United States · US · US:53401-008_4f721786-dab7-3405-e063-6294a90a6bbb
Naltrexone Hydrochloride
Orange BookUNIISPLATC N07BB04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAphena Pharma Solutions - Tennessee, LLC
CountryUS (United States)
ATC codeN07BB04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc115340100831600 TABLET, FILM COATED in 1 BOTTLE (53401-008-31)
Annotations
UNII (FDA Substance ID)
Z6375YW9SF
NALTREXONE HYDROCHLORIDE
RxCUI 105069
Orange Book
A075274
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "Z6375YW9SF",
"rxcui": "105069",
"inchikey": "RHBRMCOKKKZVRY-ITLPAZOVSA-N",
"display_name": "NALTREXONE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"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": "53401-008_4f721786-dab7-3405-e063-6294a90a6bbb",
"productndc": "53401-008",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "075274",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "001",
"approval_date": "May 26, 1999"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NALTREXONE HYDROCHLORIDE",
"proprietary_name": "Naltrexone Hydrochloride",
"active_ingred_unit": "mg/1",
"application_number": "ANDA075274",
"marketing_category": "ANDA",
"nonproprietary_name": "Naltrexone Hydrochloride",
"start_marketing_date": "20150326",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code N07BB04.
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- CZADEPENDOrpha-Devel Handels und Vertriebs GmbH, Purkersdorf
- CZADEPENDOrpha-Devel Handels und Vertriebs GmbH, Purkersdorf
- CZADEPENDOrpha-Devel Handels und Vertriebs GmbH, Purkersdorf
- CZADEPENDOrpha-Devel Handels und Vertriebs GmbH, Purkersdorf
- CZADEPENDOrpha-Devel Handels und Vertriebs GmbH, Purkersdorf
- CZADEPENDOrpha-Devel Handels und Vertriebs GmbH, Purkersdorf
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