XTAMPZA

In shortageOrange BookUNIISPLATC N02AA05

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

Identification

ManufacturerCollegium Pharmaceutical, Inc.

CountryUS (United States)

ATC codeN02AA05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
2451011010
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (24510-110-10)
ndc11
2451011020
20 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (24510-110-20)

Annotations

UNII (FDA Substance ID)

CD35PMG570

OXYCODONE

RxCUI 7804

Orange Book

N208090

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Oxycodone Hydrochloride Oral Solution

Raw payload (JSON)

{
  "unii": {
    "unii": "CD35PMG570",
    "rxcui": "7804",
    "inchikey": "BRUQQQPBMZOVGD-XFKAJCMBSA-N",
    "display_name": "OXYCODONE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "b0a5ded2-8ee2-49ca-a86c-2b28ae40f60c": {
      "match": "brand_token",
      "title": "XTAMPZA ER (OXYCODONE) CAPSULE, EXTENDED RELEASE [COLLEGIUM PHARMACEUTICAL, INC.]",
      "spl_version": "11",
      "published_date": "2026-01-06"
    }
  },
  "productid": "24510-110_fda0989d-9319-4e35-af83-fca1ec66878e",
  "productndc": "24510-110",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "208090",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "9MG",
        "product_no": "001",
        "approval_date": "Apr 26, 2016"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "13.5MG",
        "product_no": "002",
        "approval_date": "Apr 26, 2016"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "18MG",
        "product_no": "003",
        "approval_date": "Apr 26, 2016"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "27MG",
        "product_no": "004",
        "approval_date": "Apr 26, 2016"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "36MG",
        "product_no": "005",
        "approval_date": "Apr 26, 2016"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": "CII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "OXYCODONE",
  "shortage_reason": "Oxycodone Hydrochloride Oral Solution",
  "shortage_status": "current",
  "proprietary_name": "XTAMPZA",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA208090",
  "marketing_category": "NDA",
  "nonproprietary_name": "OXYCODONE",
  "start_marketing_date": "20160510",
  "active_numerator_strength": "9"
}

Related drugs

Other records sharing ATC code N02AA05.

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