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United States · US · US:71205-510_8e082b99-7601-499d-b32d-d84e4174d425

Butalbital, Acetaminophen, Caffeine

In shortageOrange BookUNIISPLATC N02BE

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

Identification

ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeN02BE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    7120551014
    14 TABLET in 1 BOTTLE (71205-510-14)
  • ndc11
    7120551030
    30 TABLET in 1 BOTTLE (71205-510-30)
  • ndc11
    7120551060
    60 TABLET in 1 BOTTLE (71205-510-60)
  • ndc11
    7120551090
    90 TABLET in 1 BOTTLE (71205-510-90)

Annotations

UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A209587
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": "71205-510_8e082b99-7601-499d-b32d-d84e4174d425",
  "productndc": "71205-510",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "209587",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "325MG;50MG;40MG",
        "product_no": "001",
        "approval_date": "Oct 31, 2018"
      }
    ],
    "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, Caffeine",
  "active_ingred_unit": "mg/1; mg/1; mg/1",
  "application_number": "ANDA209587",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Butalbital, Acetaminophen, and Caffeine",
  "start_marketing_date": "20190305",
  "active_numerator_strength": "325; 50; 40"
}

Related drugs

Other records sharing ATC code N02BE.

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