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United States · US · US:71335-3104_efa09603-93f0-42f9-9a40-239e59ebbcee
Naltrexone Hydrochloride
Orange BookUNIISPLATC N07BB04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeN07BB04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 7
- ndc11713353104130 TABLET, FILM COATED in 1 BOTTLE (71335-3104-1)
- ndc11713353104290 TABLET, FILM COATED in 1 BOTTLE (71335-3104-2)
- ndc11713353104360 TABLET, FILM COATED in 1 BOTTLE (71335-3104-3)
- ndc11713353104445 TABLET, FILM COATED in 1 BOTTLE (71335-3104-4)
- ndc117133531045120 TABLET, FILM COATED in 1 BOTTLE (71335-3104-5)
- ndc11713353104615 TABLET, FILM COATED in 1 BOTTLE (71335-3104-6)
- ndc117133531047100 TABLET, FILM COATED in 1 BOTTLE (71335-3104-7)
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": "71335-3104_efa09603-93f0-42f9-9a40-239e59ebbcee",
"productndc": "71335-3104",
"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": "20130923",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code N07BB04.
- PLAdependWalter Ritter GmbH + Co. KG
- NOAdependOrpha-Devel Handels und Vertriebs GmbH
- 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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