🇺🇸
United States · US · US:13107-059_d0765823-c018-4aae-85e9-27288fe43950
Acetaminophen and Codeine Phosphate
In shortageOrange BookUNIISPLATC N02BE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurolife Pharma, LLC
CountryUS (United States)
ATC codeN02BE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc111310705901100 TABLET in 1 BOTTLE (13107-059-01)
- ndc111310705905500 TABLET in 1 BOTTLE (13107-059-05)
- ndc11131070593030 TABLET in 1 BOTTLE (13107-059-30)
- ndc1113107059991000 TABLET in 1 BOTTLE (13107-059-99)
Annotations
UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A202800
AAAAAA
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": "13107-059_d0765823-c018-4aae-85e9-27288fe43950",
"productndc": "13107-059",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "202800",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "300MG;15MG",
"product_no": "001",
"approval_date": "Apr 15, 2013"
},
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "300MG;30MG",
"product_no": "002",
"approval_date": "Apr 15, 2013"
},
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "300MG;60MG",
"product_no": "003",
"approval_date": "Apr 15, 2013"
}
],
"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 Phosphate",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA202800",
"marketing_category": "ANDA",
"nonproprietary_name": "Acetaminophen and Codeine Phosphate",
"start_marketing_date": "20130415",
"active_numerator_strength": "300; 30"
}Related drugs
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