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United States · US · US:47335-326_b0c2b60a-dc96-483b-933e-2fed58b64372
NALTREXONE HYDROCHLORIDE
Orange BookUNIISPLATC N07BB04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeN07BB04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc114733532608100 TABLET, FILM COATED in 1 BOTTLE (47335-326-08)
- ndc1147335326181000 TABLET, FILM COATED in 1 BOTTLE (47335-326-18)
- ndc11473353268330 TABLET, FILM COATED in 1 BOTTLE (47335-326-83)
- ndc114733532688100 TABLET, FILM COATED in 1 BOTTLE (47335-326-88)
Annotations
UNII (FDA Substance ID)
Z6375YW9SF
NALTREXONE HYDROCHLORIDE
RxCUI 105069
Orange Book
A090356
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": "47335-326_b0c2b60a-dc96-483b-933e-2fed58b64372",
"productndc": "47335-326",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "090356",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "001",
"approval_date": "Feb 24, 2012"
}
],
"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": "ANDA090356",
"marketing_category": "ANDA",
"nonproprietary_name": "NALTREXONE HYDROCHLORIDE",
"start_marketing_date": "20120229",
"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
Access this data programmatically
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