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United States · US · US:76420-821_3c8f10b4-0551-c65f-e063-6294a90a3543
ACETAMINOPHEN AND CODEINE PHOSPHATE
In shortageOrange BookUNIISPLATC N02BE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAsclemed USA, Inc.
CountryUS (United States)
ATC codeN02BE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 13
- ndc117642082100100 TABLET in 1 BOTTLE (76420-821-00)
- ndc1176420821011 TABLET in 1 BOTTLE (76420-821-01)
- ndc1176420821033 TABLET in 1 BOTTLE (76420-821-03)
- ndc1176420821055 TABLET in 1 BOTTLE (76420-821-05)
- ndc11764208211010 TABLET in 1 BOTTLE (76420-821-10)
- ndc11764208211212 TABLET in 1 BOTTLE (76420-821-12)
- ndc11764208211515 TABLET in 1 BOTTLE (76420-821-15)
- ndc11764208212020 TABLET in 1 BOTTLE (76420-821-20)
- ndc11764208212424 TABLET in 1 BOTTLE (76420-821-24)
- ndc11764208213030 TABLET in 1 BOTTLE (76420-821-30)
- ndc117642082150500 TABLET in 1 BOTTLE (76420-821-50)
- ndc11764208216060 TABLET in 1 BOTTLE (76420-821-60)
- ndc11764208219090 TABLET in 1 BOTTLE (76420-821-90)
Annotations
UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A211610
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": "76420-821_3c8f10b4-0551-c65f-e063-6294a90a3543",
"productndc": "76420-821",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "211610",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "300MG;15MG",
"product_no": "001",
"approval_date": "Jun 27, 2019"
},
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "300MG;30MG",
"product_no": "002",
"approval_date": "Jun 27, 2019"
},
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "300MG;60MG",
"product_no": "003",
"approval_date": "Jun 27, 2019"
}
],
"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": "ANDA211610",
"marketing_category": "ANDA",
"nonproprietary_name": "acetaminophen and codeine phosphate",
"start_marketing_date": "20190802",
"active_numerator_strength": "300; 30"
}Related drugs
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