Oxycodone and Acetaminophen

In shortageOrange BookUNIISPLATC N02BE

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerProficient Rx LP

CountryUS (United States)

ATC codeN02BE

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
6318782315
15 TABLET in 1 BOTTLE (63187-823-15)
ndc11
6318782320
20 TABLET in 1 BOTTLE (63187-823-20)
ndc11
6318782330
30 TABLET in 1 BOTTLE (63187-823-30)
ndc11
6318782360
60 TABLET in 1 BOTTLE (63187-823-60)
ndc11
6318782390
90 TABLET in 1 BOTTLE (63187-823-90)

Annotations

UNII (FDA Substance ID)

362O9ITL9D

ACETAMINOPHEN

RxCUI 161

Orange Book

A201972

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": "63187-823_bd442a36-9c53-4088-bc80-749efcfa0bc5",
  "productndc": "63187-823",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "201972",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "325MG;2.5MG",
        "product_no": "001",
        "approval_date": "Jul 15, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "325MG;5MG",
        "product_no": "002",
        "approval_date": "Jul 15, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "325MG;7.5MG",
        "product_no": "003",
        "approval_date": "Jul 15, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "325MG;10MG",
        "product_no": "004",
        "approval_date": "Jul 15, 2013"
      }
    ],
    "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": "ANDA201972",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Oxycodone and Acetaminophen",
  "start_marketing_date": "20161201",
  "active_numerator_strength": "325; 10"
}

Related drugs

Other records sharing ATC code N02BE.

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