Back to search
🇺🇸

United States · US · US:52544-082_c5c3390f-a64b-49cb-8fcb-5762dc8ee74a

Fioricet with Codeine

In shortageOrange BookUNIISPLATC N02BE

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

Identification

ManufacturerActavis Pharma, Inc.
CountryUS (United States)
ATC codeN02BE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5254408201
    100 CAPSULE in 1 BOTTLE, PLASTIC (52544-082-01)

Annotations

UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A076560
ABAB
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": {
    "c018be7d-f7b8-45e2-97b8-8e7a71740657": {
      "match": "brand_token",
      "title": "FIORICET (BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE) CAPSULE [ACTAVIS PHARMA, INC.]",
      "spl_version": "11",
      "published_date": "2025-12-11"
    }
  },
  "productid": "52544-082_c5c3390f-a64b-49cb-8fcb-5762dc8ee74a",
  "productndc": "52544-082",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "076560",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "325MG;50MG;40MG;30MG",
        "product_no": "001",
        "approval_date": "Jun 10, 2004"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "300MG;50MG;40MG;30MG",
        "product_no": "002",
        "approval_date": "Jul 19, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE",
  "shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "Fioricet with Codeine",
  "active_ingred_unit": "mg/1; mg/1; mg/1; mg/1",
  "application_number": "ANDA076560",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate",
  "start_marketing_date": "20130729",
  "active_numerator_strength": "300; 50; 40; 30"
}

Related drugs

Other records sharing ATC code N02BE.

Access this data programmatically

Query Fioricet with Codeine and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.