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United States · US · US:0067-2039_7386648a-3c0a-4586-9b61-fd824edfdfc1

EXCEDRIN

In shortageOrange BookUNIISPLATC N02BE

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

Identification

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

Packs · 9

  • ndc11
    0067203902
    2 TABLET, FILM COATED in 1 POUCH (0067-2039-02)
  • ndc11
    0067203924
    1 BOTTLE in 1 CARTON (0067-2039-24) / 24 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    0067203930
    1 BOTTLE in 1 CARTON (0067-2039-30) / 30 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    0067203933
    1 BOTTLE in 1 CARTON (0067-2039-33) / 300 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    0067203950
    1 BOTTLE in 1 CARTON (0067-2039-50) / 50 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    0067203977
    1 BOTTLE in 1 CARTON (0067-2039-77) / 250 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    0067203983
    1 BOTTLE in 1 CARTON (0067-2039-83) / 125 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    0067203991
    1 BOTTLE in 1 CARTON (0067-2039-91) / 100 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    0067203992
    1 BOTTLE in 1 CARTON (0067-2039-92) / 200 TABLET, FILM COATED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
N020802
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": {
    "4efbd21b-92fe-96a7-e063-6294a90ac4ad": {
      "match": "brand_token",
      "title": "EXCEDRIN MIGRAINE (ACETAMINOPHEN, ASPIRIN, AND CAFFEINE) TABLET, FILM COATED [NAVAJO MANUFACTURING COMPANY INC.]",
      "spl_version": "1",
      "published_date": "2026-04-10"
    }
  },
  "productid": "0067-2039_7386648a-3c0a-4586-9b61-fd824edfdfc1",
  "productndc": "0067-2039",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "020802",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "250MG;250MG;65MG",
        "product_no": "001",
        "approval_date": "Jan 14, 1998"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "ACETAMINOPHEN; ASPIRIN; CAFFEINE",
  "shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "EXCEDRIN",
  "active_ingred_unit": "mg/1; mg/1; mg/1",
  "application_number": "NDA020802",
  "marketing_category": "NDA",
  "nonproprietary_name": "Acetaminophen, Aspirin (NSAID) and Caffeine",
  "start_marketing_date": "20100215",
  "active_numerator_strength": "250; 250; 65"
}

Related drugs

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