🇺🇸
United States · US · US:25000-108_9e2c09cd-1bd4-4a86-8911-ba904d8a76cb
Acetaminophen Extended-Release Tablets, 650 mg
Orange BookUNIISPLATC N02BE51
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMARKSANS PHARMA LIMITED
CountryUS (United States)
ATC codeN02BE51
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1125000108021 BOTTLE in 1 CARTON (25000-108-02) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE
- ndc1125000108081 BOTTLE in 1 CARTON (25000-108-08) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE
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": "25000-108_9e2c09cd-1bd4-4a86-8911-ba904d8a76cb",
"productndc": "25000-108",
"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 Extended-Release Tablets, 650 mg",
"active_ingred_unit": "mg/1",
"application_number": "ANDA215486",
"marketing_category": "ANDA",
"nonproprietary_name": "Acetaminophen",
"start_marketing_date": "20221014",
"active_numerator_strength": "650"
}Related drugs
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