🇺🇸
United States · US · US:65145-157_b6f83919-8608-4648-9ac6-e13eadac8404
Acetaminophen
Orange BookUNIISPLATC N02BE51
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCaplin Steriles Limited
CountryUS (United States)
ATC codeN02BE51
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11651451571010 POUCH in 1 CASE (65145-157-10) / 1 BAG in 1 POUCH (65145-157-01) / 100 mL in 1 BAG
Annotations
UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A219096
AP1
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": "INTRAVENOUS",
"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": "65145-157_b6f83919-8608-4648-9ac6-e13eadac8404",
"productndc": "65145-157",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "219096",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP1",
"strength": "1GM/100ML (10MG/ML)",
"product_no": "001",
"approval_date": "Dec 5, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ACETAMINOPHEN",
"proprietary_name": "Acetaminophen",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA219096",
"marketing_category": "ANDA",
"nonproprietary_name": "Acetaminophen",
"start_marketing_date": "20251218",
"active_numerator_strength": "10"
}Related drugs
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