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United States · US · US:71335-0194_ab86ae24-3103-4976-bd9d-8c90b76c5f29

Butalbital, Acetaminophen, Caffeine and Codeine Phosphate

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 · 7

  • ndc11
    7133501941
    20 CAPSULE in 1 BOTTLE (71335-0194-1)
  • ndc11
    7133501942
    90 CAPSULE in 1 BOTTLE (71335-0194-2)
  • ndc11
    7133501943
    30 CAPSULE in 1 BOTTLE (71335-0194-3)
  • ndc11
    7133501944
    60 CAPSULE in 1 BOTTLE (71335-0194-4)
  • ndc11
    7133501945
    100 CAPSULE in 1 BOTTLE (71335-0194-5)
  • ndc11
    7133501946
    15 CAPSULE in 1 BOTTLE (71335-0194-6)
  • ndc11
    7133501947
    18 CAPSULE in 1 BOTTLE (71335-0194-7)

Annotations

UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A076560
ABAB
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": "71335-0194_ab86ae24-3103-4976-bd9d-8c90b76c5f29",
  "productndc": "71335-0194",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "076560",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "325MG;50MG;40MG;30MG",
        "product_no": "001",
        "approval_date": "Jun 10, 2004"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "300MG;50MG;40MG;30MG",
        "product_no": "002",
        "approval_date": "Jul 19, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE",
  "shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "Butalbital, Acetaminophen, Caffeine and Codeine Phosphate",
  "active_ingred_unit": "mg/1; mg/1; mg/1; mg/1",
  "application_number": "ANDA076560",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Butalbital, Acetaminophen, Caffeine and Codeine Phosphate",
  "start_marketing_date": "20040701",
  "active_numerator_strength": "325; 50; 40; 30"
}

Related drugs

Other records sharing ATC code N02BE.

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