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United States · US · US:71335-9603_9cd0d6ab-cb53-47bd-9417-0ad88c4571a4

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
    7133596030
    84 TABLET in 1 BOTTLE (71335-9603-0)
  • ndc11
    7133596031
    20 TABLET in 1 BOTTLE (71335-9603-1)
  • ndc11
    7133596032
    30 TABLET in 1 BOTTLE (71335-9603-2)
  • ndc11
    7133596033
    60 TABLET in 1 BOTTLE (71335-9603-3)
  • ndc11
    7133596034
    90 TABLET in 1 BOTTLE (71335-9603-4)
  • ndc11
    7133596035
    50 TABLET in 1 BOTTLE (71335-9603-5)
  • ndc11
    7133596036
    6 TABLET in 1 BOTTLE (71335-9603-6)
  • ndc11
    7133596037
    120 TABLET in 1 BOTTLE (71335-9603-7)
  • ndc11
    7133596038
    40 TABLET in 1 BOTTLE (71335-9603-8)
  • ndc11
    7133596039
    12 TABLET in 1 BOTTLE (71335-9603-9)

Annotations

UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A211106
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": "71335-9603_9cd0d6ab-cb53-47bd-9417-0ad88c4571a4",
  "productndc": "71335-9603",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "211106",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "325MG;50MG;40MG",
        "product_no": "001",
        "approval_date": "Sep 26, 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 and Caffeine",
  "active_ingred_unit": "mg/1; mg/1; mg/1",
  "application_number": "ANDA211106",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Butalbital, Acetaminophen and Caffeine",
  "start_marketing_date": "20180926",
  "active_numerator_strength": "325; 50; 40"
}

Related drugs

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