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United States · US · US:61919-871_3a85db26-4c30-c5dc-e063-6294a90ac2a2

OXYCODONE AND ACETAMINOPHEN

In shortageOrange BookUNIISPLATC N02BE

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

Identification

ManufacturerDirect_Rx
CountryUS (United States)
ATC codeN02BE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6191987160
    60 TABLET in 1 BOTTLE (61919-871-60)
  • ndc11
    6191987172
    120 TABLET in 1 BOTTLE (61919-871-72)

Annotations

UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A207419
AAAAAAAA
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": {
    "27124cdf-a3e8-474c-9c1e-6fa48f6ddc05": {
      "match": "brand_token",
      "title": "OXYCODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]",
      "spl_version": "102",
      "published_date": "2026-06-01"
    }
  },
  "productid": "61919-871_3a85db26-4c30-c5dc-e063-6294a90ac2a2",
  "productndc": "61919-871",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "207419",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "325MG;2.5MG",
        "product_no": "001",
        "approval_date": "Mar 22, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "325MG;5MG",
        "product_no": "002",
        "approval_date": "Mar 22, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "325MG;7.5MG",
        "product_no": "003",
        "approval_date": "Mar 22, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "325MG;10MG",
        "product_no": "004",
        "approval_date": "Mar 22, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE",
  "shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "OXYCODONE AND ACETAMINOPHEN",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA207419",
  "marketing_category": "ANDA",
  "nonproprietary_name": "OXYCODONE AND ACETAMINOPHEN",
  "start_marketing_date": "20190821",
  "active_numerator_strength": "325; 10"
}

Related drugs

Other records sharing ATC code N02BE.

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