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United States · US · US:0904-6883_69ef9f35-add0-44cf-944d-fc69d1a7dd02
major acetaminophen
Orange BookUNIISPLATC N02BE51
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMajor Pharmaceuticals
CountryUS (United States)
ATC codeN02BE51
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc110904688365400 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0904-6883-65)
Annotations
UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A075077
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "362O9ITL9D",
"rxcui": "161",
"inchikey": "RZVAJINKPMORJF-UHFFFAOYSA-N",
"display_name": "ACETAMINOPHEN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"772889a1-fc68-4400-9612-6fa51d0b6878": {
"match": "brand_token",
"title": "MAJOR ORAL RINSE (0.12% CHLORHEXIDINE GLUCONATE) RINSE [CARDINAL HEALTH 107, LLC]",
"spl_version": "6",
"published_date": "2026-05-21"
}
},
"productid": "0904-6883_69ef9f35-add0-44cf-944d-fc69d1a7dd02",
"productndc": "0904-6883",
"dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
"orange_book": {
"appl_no": "075077",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "650MG",
"product_no": "001",
"approval_date": "Feb 25, 2000"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "ACETAMINOPHEN",
"proprietary_name": "major acetaminophen",
"active_ingred_unit": "mg/1",
"application_number": "ANDA075077",
"marketing_category": "ANDA",
"nonproprietary_name": "Acetaminophen",
"start_marketing_date": "20190304",
"active_numerator_strength": "650"
}Related drugs
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