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United States · US · US:13107-059_d0765823-c018-4aae-85e9-27288fe43950

Acetaminophen and Codeine Phosphate

In shortageOrange BookUNIISPLATC N02BE

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerAurolife Pharma, LLC
CountryUS (United States)
ATC codeN02BE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    1310705901
    100 TABLET in 1 BOTTLE (13107-059-01)
  • ndc11
    1310705905
    500 TABLET in 1 BOTTLE (13107-059-05)
  • ndc11
    1310705930
    30 TABLET in 1 BOTTLE (13107-059-30)
  • ndc11
    1310705999
    1000 TABLET in 1 BOTTLE (13107-059-99)

Annotations

UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A202800
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": "13107-059_d0765823-c018-4aae-85e9-27288fe43950",
  "productndc": "13107-059",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "202800",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "300MG;15MG",
        "product_no": "001",
        "approval_date": "Apr 15, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "300MG;30MG",
        "product_no": "002",
        "approval_date": "Apr 15, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "300MG;60MG",
        "product_no": "003",
        "approval_date": "Apr 15, 2013"
      }
    ],
    "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": "ANDA202800",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Acetaminophen and Codeine Phosphate",
  "start_marketing_date": "20130415",
  "active_numerator_strength": "300; 30"
}

Related drugs

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