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United States · US · US:16714-170_c884344b-2520-4874-866c-bf9798b506d3

Butalbital, Acetaminophen, and Caffeine

In shortageOrange BookUNIISPLATC N02BE

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerNORTHSTAR RX LLC
CountryUS (United States)
ATC codeN02BE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    1671417001
    100 CAPSULE in 1 BOTTLE (16714-170-01)

Annotations

UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A213046
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": "16714-170_c884344b-2520-4874-866c-bf9798b506d3",
  "productndc": "16714-170",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "213046",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "300MG;50MG;40MG",
        "product_no": "001",
        "approval_date": "Jul 1, 2020"
      }
    ],
    "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": "ANDA213046",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Butalbital, Acetaminophen, and Caffeine",
  "start_marketing_date": "20200701",
  "active_numerator_strength": "300; 50; 40"
}

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