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United States · US · US:72162-1591_215e2a6f-ec32-4836-8fad-22c8b40ba1f1

Butalbital, Acetaminophen, Caffeine and Codeine Phosphate

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
    7216215912
    20 CAPSULE in 1 BOTTLE, PLASTIC (72162-1591-2)

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": {
    "95a33c9b-79a6-47c7-8433-fc217950b88f": {
      "match": "brand_token",
      "title": "BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [BRYANT RANCH PREPACK]",
      "spl_version": "16",
      "published_date": "2026-05-28"
    }
  },
  "productid": "72162-1591_215e2a6f-ec32-4836-8fad-22c8b40ba1f1",
  "productndc": "72162-1591",
  "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": "Butalbital, Acetaminophen, Caffeine and Codeine Phosphate",
  "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": "20040701",
  "active_numerator_strength": "325; 50; 40; 30"
}

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