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United States · US · US:60760-865_36229f4e-5921-2fcd-e063-6294a90af60d

Butalbital, Acetaminophen and Caffeine

In shortageOrange BookUNIISPLATC N02BE

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

Identification

ManufacturerST. MARY'S MEDICAL PARK PHARMACY
CountryUS (United States)
ATC codeN02BE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6076086512
    12 TABLET in 1 BOTTLE, PLASTIC (60760-865-12)

Annotations

UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A040864
AA
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": "60760-865_36229f4e-5921-2fcd-e063-6294a90af60d",
  "productndc": "60760-865",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "040864",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "325MG;50MG;40MG",
        "product_no": "001",
        "approval_date": "Dec 1, 2008"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ACETAMINOPHEN; BUTALBITAL; CAFFEINE",
  "shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "Butalbital, Acetaminophen and Caffeine",
  "active_ingred_unit": "mg/1; mg/1; mg/1",
  "application_number": "ANDA040864",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Butalbital, Acetaminophen and Caffeine",
  "start_marketing_date": "20220629",
  "active_numerator_strength": "325; 50; 40"
}

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