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United States · US · US:63629-8834_71adc4c3-b213-43de-8074-fdc2c2bed2b3

OXYCODONE AND ACETAMINOPHEN

In shortageOrange BookUNIISPLATC N02BE

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

Identification

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

Packs · 9

  • ndc11
    6362988341
    30 TABLET in 1 BOTTLE (63629-8834-1)
  • ndc11
    6362988342
    120 TABLET in 1 BOTTLE (63629-8834-2)
  • ndc11
    6362988343
    90 TABLET in 1 BOTTLE (63629-8834-3)
  • ndc11
    6362988344
    28 TABLET in 1 BOTTLE (63629-8834-4)
  • ndc11
    6362988345
    60 TABLET in 1 BOTTLE (63629-8834-5)
  • ndc11
    6362988346
    20 TABLET in 1 BOTTLE (63629-8834-6)
  • ndc11
    6362988347
    45 TABLET in 1 BOTTLE (63629-8834-7)
  • ndc11
    6362988348
    75 TABLET in 1 BOTTLE (63629-8834-8)
  • ndc11
    6362988349
    100 TABLET in 1 BOTTLE (63629-8834-9)

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": "63629-8834_71adc4c3-b213-43de-8074-fdc2c2bed2b3",
  "productndc": "63629-8834",
  "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": "20170411",
  "active_numerator_strength": "325; 10"
}

Related drugs

Other records sharing ATC code N02BE.

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