🇺🇸
United States · US · US:63187-491_a4e384a6-1887-4053-8263-54fc51823174
Acetaminophen and Codeine
In shortageOrange BookUNIISPLATC N02BE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeN02BE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc11631874912020 TABLET in 1 BOTTLE (63187-491-20)
- ndc11631874913030 TABLET in 1 BOTTLE (63187-491-30)
- ndc11631874916060 TABLET in 1 BOTTLE (63187-491-60)
- ndc11631874919090 TABLET in 1 BOTTLE (63187-491-90)
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": "63187-491_a4e384a6-1887-4053-8263-54fc51823174",
"productndc": "63187-491",
"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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