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United States · US · US:72245-681_4c0a051e-78a7-de5f-e063-6294a90a90c9

Prolate

In shortageOrange BookUNIISPLATC N02BE

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

Identification

ManufacturerForte Bio-Pharma LLC
CountryUS (United States)
ATC codeN02BE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7224568103
    30 TABLET in 1 BOTTLE, PLASTIC (72245-681-03)
  • ndc11
    7224568110
    100 TABLET in 1 BOTTLE, PLASTIC (72245-681-10)

Annotations

UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A040608
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": {
    "9d75ad3b-bc9b-0c22-e053-2a95a90ac71e": {
      "match": "brand_token",
      "title": "PROLATE (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) SOLUTION [FORTE BIO-PHARMA LLC]",
      "spl_version": "7",
      "published_date": "2026-04-27"
    }
  },
  "productid": "72245-681_4c0a051e-78a7-de5f-e063-6294a90a90c9",
  "productndc": "72245-681",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "040608",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "300MG;2.5MG",
        "product_no": "001",
        "approval_date": "Dec 30, 2005"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "300MG;5MG",
        "product_no": "002",
        "approval_date": "Dec 30, 2005"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "300MG;7.5MG",
        "product_no": "003",
        "approval_date": "Dec 30, 2005"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "300MG;10MG",
        "product_no": "004",
        "approval_date": "Dec 30, 2005"
      }
    ],
    "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": "Prolate",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA040608",
  "marketing_category": "ANDA",
  "nonproprietary_name": "oxycodone and acetaminophen",
  "start_marketing_date": "20200217",
  "active_numerator_strength": "300; 5"
}

Related drugs

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