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United States · US · US:51991-074_a41a61f0-e530-4fb5-8198-bdc866219e33

Ascomp with Codeine

Orange BookUNIISPLATC A01AD

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

Identification

ManufacturerBreckenridge Pharmaceutical, Inc.
CountryUS (United States)
ATC codeA01AD
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5199107401
    100 CAPSULE in 1 BOTTLE, PLASTIC (51991-074-01)
  • ndc11
    5199107405
    500 CAPSULE in 1 BOTTLE, PLASTIC (51991-074-05)

Annotations

UNII (FDA Substance ID)
R16CO5Y76E
ASPIRIN
RxCUI 1191
Orange Book
A075231
AB
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": {
    "1cab3106-1064-4b42-892b-39f405d9e02f": {
      "match": "brand_token",
      "title": "ASCOMP WITH CODEINE (BUTALBITAL, ASPIRIN, CAFEINE, AND CODEINE PHOSPHATE) CAPSULE [LGM PHARMA SOLUTIONS, LLC]",
      "spl_version": "15",
      "published_date": "2026-04-08"
    }
  },
  "productid": "51991-074_a41a61f0-e530-4fb5-8198-bdc866219e33",
  "productndc": "51991-074",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "075231",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "325MG;50MG;40MG;30MG",
        "product_no": "001",
        "approval_date": "Nov 30, 2001"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE",
  "proprietary_name": "Ascomp with Codeine",
  "active_ingred_unit": "mg/1; mg/1; mg/1; mg/1",
  "application_number": "ANDA075231",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Butalbital, Aspirin, Caffeine and Codeine Phosphate",
  "start_marketing_date": "20090501",
  "active_numerator_strength": "325; 50; 40; 30"
}

Related drugs

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