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United States · US · US:63629-2190_3b8ef94a-da42-46b5-9fa9-2fac9ed6e7c3

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 · 1

  • ndc11
    6362921901
    100 TABLET in 1 BOTTLE, PLASTIC (63629-2190-1)

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": "63629-2190_3b8ef94a-da42-46b5-9fa9-2fac9ed6e7c3",
  "productndc": "63629-2190",
  "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; 7.5"
}

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