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United States · US · US:65862-922_e0a5c380-895e-4f05-9eaf-b27b17ad41e1

Tramadol Hydrochloride and Acetaminophen

In shortageOrange BookUNIISPLATC N02BE

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

Identification

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

Packs · 5

  • ndc11
    6586292201
    100 TABLET, FILM COATED in 1 BOTTLE (65862-922-01)
  • ndc11
    6586292205
    500 TABLET, FILM COATED in 1 BOTTLE (65862-922-05)
  • ndc11
    6586292230
    30 TABLET, FILM COATED in 1 BOTTLE (65862-922-30)
  • ndc11
    6586292278
    10 BLISTER PACK in 1 CARTON (65862-922-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-922-10)
  • ndc11
    6586292299
    1000 TABLET, FILM COATED in 1 BOTTLE (65862-922-99)

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": "65862-922_e0a5c380-895e-4f05-9eaf-b27b17ad41e1",
  "productndc": "65862-922",
  "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": "20170322",
  "active_numerator_strength": "325; 37.5"
}

Related drugs

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