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United States · US · US:71335-2270_0e3608c9-b97a-4f77-9cd8-d63f6d55cab1

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
    7133522700
    84 TABLET in 1 BOTTLE (71335-2270-0)
  • ndc11
    7133522701
    20 TABLET in 1 BOTTLE (71335-2270-1)
  • ndc11
    7133522702
    30 TABLET in 1 BOTTLE (71335-2270-2)
  • ndc11
    7133522703
    60 TABLET in 1 BOTTLE (71335-2270-3)
  • ndc11
    7133522704
    90 TABLET in 1 BOTTLE (71335-2270-4)
  • ndc11
    7133522705
    50 TABLET in 1 BOTTLE (71335-2270-5)
  • ndc11
    7133522706
    6 TABLET in 1 BOTTLE (71335-2270-6)
  • ndc11
    7133522707
    120 TABLET in 1 BOTTLE (71335-2270-7)
  • ndc11
    7133522708
    40 TABLET in 1 BOTTLE (71335-2270-8)
  • ndc11
    7133522709
    12 TABLET in 1 BOTTLE (71335-2270-9)

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": "71335-2270_0e3608c9-b97a-4f77-9cd8-d63f6d55cab1",
  "productndc": "71335-2270",
  "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"
}

Related drugs

Other records sharing ATC code N02BE.

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