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United States · US · US:50090-4610_a18dafdc-8a81-4129-bbc4-808083c24b23

ACETAMINOPHEN AND CODEINE PHOSPHATE

In shortageOrange BookUNIISPLATC N02BE

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

Identification

ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeN02BE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 6

  • ndc11
    5009046100
    10 TABLET in 1 BOTTLE (50090-4610-0)
  • ndc11
    5009046101
    12 TABLET in 1 BOTTLE (50090-4610-1)
  • ndc11
    5009046102
    15 TABLET in 1 BOTTLE (50090-4610-2)
  • ndc11
    5009046103
    20 TABLET in 1 BOTTLE (50090-4610-3)
  • ndc11
    5009046104
    30 TABLET in 1 BOTTLE (50090-4610-4)
  • ndc11
    5009046107
    100 TABLET in 1 BOTTLE (50090-4610-7)

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": "50090-4610_a18dafdc-8a81-4129-bbc4-808083c24b23",
  "productndc": "50090-4610",
  "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": "20010531",
  "active_numerator_strength": "300; 30"
}

Related drugs

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