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United States · US · US:53746-617_90386181-256c-422d-8f7e-1bf0959b69bb

Tramadol Hydrochloride and Acetaminophen

In shortageOrange BookUNIISPLATC N02BE

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

Identification

ManufacturerAmneal Pharmaceuticals of New York LLC
CountryUS (United States)
ATC codeN02BE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    5374661701
    100 TABLET in 1 BOTTLE (53746-617-01)
  • ndc11
    5374661705
    500 TABLET in 1 BOTTLE (53746-617-05)
  • ndc11
    5374661710
    1000 TABLET in 1 BOTTLE (53746-617-10)
  • ndc11
    5374661730
    30 TABLET in 1 BOTTLE (53746-617-30)

Annotations

UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A090485
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": "53746-617_90386181-256c-422d-8f7e-1bf0959b69bb",
  "productndc": "53746-617",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "090485",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "325MG;37.5MG",
        "product_no": "001",
        "approval_date": "Dec 9, 2009"
      }
    ],
    "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": "ANDA090485",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tramadol Hydrochloride and Acetaminophen",
  "start_marketing_date": "20091217",
  "active_numerator_strength": "325; 37.5"
}

Related drugs

Other records sharing ATC code N02BE.

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