Back to search
🇺🇸

United States · US · US:72189-382_2c4cd58a-0293-714d-e063-6394a90a5edd

Tramadol Hydrochloride and Acetaminophen

In shortageOrange BookUNIISPLATC N02BE

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

Identification

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

Packs · 1

  • ndc11
    7218938260
    60 TABLET, FILM COATED in 1 BOTTLE (72189-382-60)

Annotations

UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A207152
AB
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": {
    "a6cbd5de-8ae5-49e3-b89b-e35536b115d8": {
      "match": "brand_token",
      "title": "TRAMADOL HYDROCHLORIDE TABLET [STRIDES PHARMA SCIENCE LIMITED]",
      "spl_version": "2",
      "published_date": "2026-06-02"
    }
  },
  "productid": "72189-382_2c4cd58a-0293-714d-e063-6394a90a5edd",
  "productndc": "72189-382",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "207152",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "325MG;37.5MG",
        "product_no": "001",
        "approval_date": "Mar 22, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE",
  "shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "Tramadol Hydrochloride and Acetaminophen",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA207152",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tramadol Hydrochloride and Acetaminophen",
  "start_marketing_date": "20220914",
  "active_numerator_strength": "325; 37.5"
}

Related drugs

Other records sharing ATC code N02BE.

Access this data programmatically

Query Tramadol Hydrochloride and Acetaminophen and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.