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United States · US · US:71335-1764_5bedfb2b-f5ea-457e-a4d0-eeaba654c6e0

Butalbital, Acetaminophen, 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
    7133517640
    84 TABLET in 1 BOTTLE (71335-1764-0)
  • ndc11
    7133517641
    20 TABLET in 1 BOTTLE (71335-1764-1)
  • ndc11
    7133517642
    30 TABLET in 1 BOTTLE (71335-1764-2)
  • ndc11
    7133517643
    60 TABLET in 1 BOTTLE (71335-1764-3)
  • ndc11
    7133517644
    90 TABLET in 1 BOTTLE (71335-1764-4)
  • ndc11
    7133517645
    50 TABLET in 1 BOTTLE (71335-1764-5)
  • ndc11
    7133517646
    6 TABLET in 1 BOTTLE (71335-1764-6)
  • ndc11
    7133517647
    120 TABLET in 1 BOTTLE (71335-1764-7)
  • ndc11
    7133517648
    40 TABLET in 1 BOTTLE (71335-1764-8)
  • ndc11
    7133517649
    12 TABLET in 1 BOTTLE (71335-1764-9)

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": "71335-1764_5bedfb2b-f5ea-457e-a4d0-eeaba654c6e0",
  "productndc": "71335-1764",
  "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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