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United States · US · US:71335-2182_51816b9f-bb8e-42cb-bd94-3502169d6129

ENDOCET

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
    7133521821
    30 TABLET in 1 BOTTLE (71335-2182-1)
  • ndc11
    7133521822
    120 TABLET in 1 BOTTLE (71335-2182-2)
  • ndc11
    7133521823
    90 TABLET in 1 BOTTLE (71335-2182-3)
  • ndc11
    7133521824
    28 TABLET in 1 BOTTLE (71335-2182-4)
  • ndc11
    7133521825
    60 TABLET in 1 BOTTLE (71335-2182-5)
  • ndc11
    7133521826
    20 TABLET in 1 BOTTLE (71335-2182-6)
  • ndc11
    7133521827
    45 TABLET in 1 BOTTLE (71335-2182-7)
  • ndc11
    7133521828
    75 TABLET in 1 BOTTLE (71335-2182-8)
  • ndc11
    7133521829
    100 TABLET in 1 BOTTLE (71335-2182-9)

Annotations

UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A040330
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": {
    "944d3e60-7eee-11de-a413-0002a5d5c51b": {
      "match": "brand_token",
      "title": "ENDOCET (OXYCODONE AND ACETAMINOPHEN) TABLET [PAR HEALTH USA, LLC]",
      "spl_version": "55",
      "published_date": "2026-05-28"
    }
  },
  "productid": "71335-2182_51816b9f-bb8e-42cb-bd94-3502169d6129",
  "productndc": "71335-2182",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "040330",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AA",
        "strength": "325MG;2.5MG",
        "product_no": "001",
        "approval_date": "Jun 25, 1999"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AA",
        "strength": "325MG;5MG",
        "product_no": "002",
        "approval_date": "Jun 25, 1999"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AA",
        "strength": "325MG;7.5MG",
        "product_no": "003",
        "approval_date": "Nov 23, 2001"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AA",
        "strength": "325MG;10MG",
        "product_no": "004",
        "approval_date": "Nov 23, 2001"
      }
    ],
    "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": "ENDOCET",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA040330",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Oxycodone and Acetaminophen",
  "start_marketing_date": "20030306",
  "active_numerator_strength": "325; 10"
}

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