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United States · US · US:71335-2630_eab10910-f579-4542-a999-4d3eb874d3cc

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

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 · 10

  • ndc11
    7133526300
    84 TABLET in 1 BOTTLE (71335-2630-0)
  • ndc11
    7133526301
    20 TABLET in 1 BOTTLE (71335-2630-1)
  • ndc11
    7133526302
    30 TABLET in 1 BOTTLE (71335-2630-2)
  • ndc11
    7133526303
    60 TABLET in 1 BOTTLE (71335-2630-3)
  • ndc11
    7133526304
    90 TABLET in 1 BOTTLE (71335-2630-4)
  • ndc11
    7133526305
    50 TABLET in 1 BOTTLE (71335-2630-5)
  • ndc11
    7133526306
    6 TABLET in 1 BOTTLE (71335-2630-6)
  • ndc11
    7133526307
    120 TABLET in 1 BOTTLE (71335-2630-7)
  • ndc11
    7133526308
    40 TABLET in 1 BOTTLE (71335-2630-8)
  • ndc11
    7133526309
    12 TABLET in 1 BOTTLE (71335-2630-9)

Annotations

UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A214287
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": "71335-2630_eab10910-f579-4542-a999-4d3eb874d3cc",
  "productndc": "71335-2630",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "214287",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "325MG;50MG;40MG",
        "product_no": "001",
        "approval_date": "Jan 18, 2024"
      }
    ],
    "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": "ANDA214287",
  "marketing_category": "ANDA",
  "nonproprietary_name": "BUTALBITAL, ACETAMINOPHEN AND CAFFEINE",
  "start_marketing_date": "20240501",
  "active_numerator_strength": "325; 50; 40"
}

Related drugs

Other records sharing ATC code N02BE.

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