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United States · US · US:68047-752_41348343-4fef-7234-e063-6394a90af41d
ALLZITAL
In shortageOrange BookUNIIATC N02BE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLarken Laboratories, Inc.
CountryUS (United States)
ATC codeN02BE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc116804775201100 TABLET in 1 BOTTLE (68047-752-01)
- ndc11680477523030 TABLET in 1 BOTTLE (68047-752-30)
Annotations
UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A203484
AAAA
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",
"productid": "68047-752_41348343-4fef-7234-e063-6394a90af41d",
"productndc": "68047-752",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "203484",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AA",
"strength": "325MG;25MG",
"product_no": "001",
"approval_date": "Dec 4, 2015"
},
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "325MG;50MG",
"product_no": "002",
"approval_date": "Dec 4, 2015"
}
],
"appl_type": "A"
},
"dea_schedule": "CIII",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ACETAMINOPHEN; BUTALBITAL",
"shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
"shortage_status": "current",
"proprietary_name": "ALLZITAL",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA203484",
"marketing_category": "ANDA",
"nonproprietary_name": "butalbital and acetaminophen",
"start_marketing_date": "20151204",
"active_numerator_strength": "325; 25"
}Related drugs
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