🇺🇸
United States · US · US:64950-374_87cb7b3c-3ed5-4a40-a486-7713bb2b6e3e
Acetaminophen and Codeine Phosphate
In shortageOrange BookUNIISPLATC N02BE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGenus Lifesciences Inc.
CountryUS (United States)
ATC codeN02BE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc116495037404118 mL in 1 BOTTLE, PLASTIC (64950-374-04)
- ndc116495037416473 mL in 1 BOTTLE, PLASTIC (64950-374-16)
Annotations
UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A087508
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": "64950-374_87cb7b3c-3ed5-4a40-a486-7713bb2b6e3e",
"productndc": "64950-374",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "087508",
"products": [
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "120MG/5ML;12MG/5ML",
"product_no": "001",
"approval_date": "Approved Prior to Jan 1, 1982"
}
],
"appl_type": "A"
},
"dea_schedule": "CV",
"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/5mL; mg/5mL",
"application_number": "ANDA087508",
"marketing_category": "ANDA",
"nonproprietary_name": "Acetaminophen and Codeine Phosphate",
"start_marketing_date": "20230810",
"active_numerator_strength": "120; 12"
}Related drugs
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