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United States · US · US:79739-7192_1383f9e3-02c6-4363-920c-8e24e51f22e0

Butalbital, Aspirin, and Caffeine

Orange BookUNIISPLATC A01AD

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

Identification

ManufacturerLGM PHARMA SOLUTIONS, LLC
CountryUS (United States)
ATC codeA01AD
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7973971921
    100 CAPSULE in 1 BOTTLE (79739-7192-1)
  • ndc11
    7973971925
    500 CAPSULE in 1 BOTTLE (79739-7192-5)

Annotations

UNII (FDA Substance ID)
R16CO5Y76E
ASPIRIN
RxCUI 1191
Orange Book
A205230
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "R16CO5Y76E",
    "rxcui": "1191",
    "inchikey": "BSYNRYMUTXBXSQ-UHFFFAOYSA-N",
    "display_name": "ASPIRIN",
    "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": "79739-7192_1383f9e3-02c6-4363-920c-8e24e51f22e0",
  "productndc": "79739-7192",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "205230",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "500MG;50MG;40MG",
        "product_no": "001",
        "approval_date": "Oct 18, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ASPIRIN; BUTALBITAL; CAFFEINE",
  "proprietary_name": "Butalbital, Aspirin, and Caffeine",
  "active_ingred_unit": "mg/1; mg/1; mg/1",
  "application_number": "ANDA205230",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Butalbital, Aspirin, and Caffeine",
  "start_marketing_date": "20211018",
  "active_numerator_strength": "500; 50; 40"
}

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