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United States · US · US:62207-680_44e22bcf-1db0-3cc2-e063-6294a90a3e2a

Acetaminophen, Aspirin and Caffeine

In shortageOrange BookUNIISPLATC N02BE

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

Identification

ManufacturerGranules India Ltd
CountryUS (United States)
ATC codeN02BE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    6220768047
    500 TABLET in 1 BOTTLE (62207-680-47)
  • ndc11
    6220768051
    1 BOTTLE in 1 CARTON (62207-680-51) / 10 TABLET in 1 BOTTLE
  • ndc11
    6220768098
    22500 TABLET in 1 BOX (62207-680-98)
  • ndc11
    6220768099
    4500 TABLET in 1 POUCH (62207-680-99)

Annotations

UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A214039
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": {
    "353ef34f-760d-ae92-e063-6294a90a5b4a": {
      "match": "brand_token",
      "title": "ACETAMINOPHEN, DEXTROMETHORPHAN HBR ,GUAIFENESIN CAPSULE, LIQUID FILLED [SOFTGEL HEALTHCARE PVT LTD]",
      "spl_version": "5",
      "published_date": "2026-04-28"
    }
  },
  "productid": "62207-680_44e22bcf-1db0-3cc2-e063-6294a90a3e2a",
  "productndc": "62207-680",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "214039",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "250MG;250MG;65MG",
        "product_no": "001",
        "approval_date": "Feb 23, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "ACETAMINOPHEN; ASPIRIN; CAFFEINE",
  "shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "Acetaminophen, Aspirin and Caffeine",
  "active_ingred_unit": "mg/1; mg/1; mg/1",
  "application_number": "ANDA214039",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Acetaminophen, Aspirin and Caffeine",
  "start_marketing_date": "20210415",
  "active_numerator_strength": "250; 250; 65"
}

Related drugs

Other records sharing ATC code N02BE.

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