🇺🇸
United States · US · US:65162-033_75a6d334-42b8-44d0-a4a1-fd3eeb95008f
Acetaminophen and Codeine
In shortageOrange BookUNIISPLATC N02BE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals LLC
CountryUS (United States)
ATC codeN02BE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc116516203310100 TABLET in 1 BOTTLE (65162-033-10)
- ndc1165162033111000 TABLET in 1 BOTTLE (65162-033-11)
- ndc116516203350500 TABLET in 1 BOTTLE (65162-033-50)
Annotations
UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A040779
AA
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Acetaminophen; Oxycodone Hydrochloride Tablet
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": "65162-033_75a6d334-42b8-44d0-a4a1-fd3eeb95008f",
"productndc": "65162-033",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "040779",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "300MG;30MG",
"product_no": "001",
"approval_date": "May 29, 2008"
}
],
"appl_type": "A"
},
"dea_schedule": "CIII",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ACETAMINOPHEN; CODEINE PHOSPHATE",
"shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
"shortage_status": "current",
"proprietary_name": "Acetaminophen and Codeine",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA040779",
"marketing_category": "ANDA",
"nonproprietary_name": "Acetaminophen and Codeine",
"start_marketing_date": "20080529",
"active_numerator_strength": "300; 30"
}Related drugs
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