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United States · US · US:76420-914_2ef14964-4fa1-9fb6-e063-6294a90aff36
Acetaminophen
Orange BookUNIISPLATC N02BE51
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAsclemed USA, Inc.
CountryUS (United States)
ATC codeN02BE51
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 6
- ndc117642091401100 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-914-01)
- ndc11764209140550 BOTTLE in 1 CARTON (76420-914-05) / 1 TABLET, EXTENDED RELEASE in 1 BOTTLE
- ndc117642091426225 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-914-26)
- ndc117642091440400 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-914-40)
- ndc1176420914421 BOTTLE in 1 CARTON (76420-914-42) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE
- ndc11764209146060 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-914-60)
Annotations
UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A215486
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": {
"44520aa1-b63f-4239-e063-6394a90a5e14": {
"match": "brand_token",
"title": "ACETAMINOPHEN LIQUID / ACETAMINOPHEN DIPHENHYDRAMINE HCL LIQUID (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [KROGER]",
"spl_version": "2",
"published_date": "2026-06-02"
}
},
"productid": "76420-914_2ef14964-4fa1-9fb6-e063-6294a90aff36",
"productndc": "76420-914",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "215486",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "650MG",
"product_no": "001",
"approval_date": "Aug 25, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "ACETAMINOPHEN",
"proprietary_name": "Acetaminophen",
"active_ingred_unit": "mg/1",
"application_number": "ANDA215486",
"marketing_category": "ANDA",
"nonproprietary_name": "Acetaminophen tablet extended release",
"start_marketing_date": "20211004",
"active_numerator_strength": "650"
}Related drugs
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