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United States · US · US:71335-0014_63e4eb6a-b262-44d1-974b-633876a9c563
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
- ndc11713350014130 TABLET, FILM COATED in 1 BOTTLE (71335-0014-1)
- ndc11713350014290 TABLET, FILM COATED in 1 BOTTLE (71335-0014-2)
- ndc11713350014360 TABLET, FILM COATED in 1 BOTTLE (71335-0014-3)
- ndc11713350014445 TABLET, FILM COATED in 1 BOTTLE (71335-0014-4)
- ndc117133500145120 TABLET, FILM COATED in 1 BOTTLE (71335-0014-5)
- ndc11713350014615 TABLET, FILM COATED in 1 BOTTLE (71335-0014-6)
- ndc117133500147100 TABLET, FILM COATED in 1 BOTTLE (71335-0014-7)
Annotations
UNII (FDA Substance ID)
Z6375YW9SF
NALTREXONE HYDROCHLORIDE
RxCUI 105069
Orange Book
A091205
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": "71335-0014_63e4eb6a-b262-44d1-974b-633876a9c563",
"productndc": "71335-0014",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "091205",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "001",
"approval_date": "Aug 17, 2011"
}
],
"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": "ANDA091205",
"marketing_category": "ANDA",
"nonproprietary_name": "Naltrexone Hydrochloride",
"start_marketing_date": "20120118",
"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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