🇺🇸
United States · US · US:67544-002_c4cf2f28-c73e-4370-843e-487b7b42e077
ACETAMINOPHEN AND CODEINE PHOSPHATE
In shortageOrange BookUNIISPLATC N02BE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAphena Pharma Solutions - Tennessee, LLC
CountryUS (United States)
ATC codeN02BE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 19
- ndc1167544002099 TABLET in 1 BOTTLE, PLASTIC (67544-002-09)
- ndc11675440021515 TABLET in 1 BOTTLE, PLASTIC (67544-002-15)
- ndc11675440022020 TABLET in 1 BOTTLE, PLASTIC (67544-002-20)
- ndc11675440023030 TABLET in 1 BOTTLE, PLASTIC (67544-002-30)
- ndc11675440024040 TABLET in 1 BOTTLE, PLASTIC (67544-002-40)
- ndc11675440024545 TABLET in 1 BOTTLE, PLASTIC (67544-002-45)
- ndc11675440024656 TABLET in 1 BOTTLE, PLASTIC (67544-002-46)
- ndc11675440025050 TABLET in 1 BOTTLE, PLASTIC (67544-002-50)
- ndc11675440025360 TABLET in 1 BOTTLE, PLASTIC (67544-002-53)
- ndc11675440025484 TABLET in 1 BOTTLE, PLASTIC (67544-002-54)
- ndc11675440025575 TABLET in 1 BOTTLE, PLASTIC (67544-002-55)
- ndc11675440026090 TABLET in 1 BOTTLE, PLASTIC (67544-002-60)
- ndc116754400270120 TABLET in 1 BOTTLE, PLASTIC (67544-002-70)
- ndc116754400272112 TABLET in 1 BOTTLE, PLASTIC (67544-002-72)
- ndc116754400275150 TABLET in 1 BOTTLE, PLASTIC (67544-002-75)
- ndc116754400280180 TABLET in 1 BOTTLE, PLASTIC (67544-002-80)
- ndc116754400285200 TABLET in 1 BOTTLE, PLASTIC (67544-002-85)
- ndc116754400290240 TABLET in 1 BOTTLE, PLASTIC (67544-002-90)
- ndc116754400293300 TABLET in 1 BOTTLE, PLASTIC (67544-002-93)
Annotations
UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A040419
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": "67544-002_c4cf2f28-c73e-4370-843e-487b7b42e077",
"productndc": "67544-002",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "040419",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AA",
"strength": "300MG;15MG",
"product_no": "001",
"approval_date": "May 31, 2001"
},
{
"rs": true,
"rld": false,
"te_code": "AA",
"strength": "300MG;30MG",
"product_no": "002",
"approval_date": "May 31, 2001"
},
{
"rs": true,
"rld": false,
"te_code": "AA",
"strength": "300MG;60MG",
"product_no": "003",
"approval_date": "May 31, 2001"
}
],
"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": "ANDA040419",
"marketing_category": "ANDA",
"nonproprietary_name": "acetaminophen and codeine phosphate",
"start_marketing_date": "20110706",
"active_numerator_strength": "300; 30"
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