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United States · US · US:71335-1742_c3c5af52-f6d0-43f9-8adf-c046a433c4db

Tramadol Hydrochloride and Acetaminophen

In shortageOrange BookUNIISPLATC N02BE

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

Identification

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

Packs · 8

  • ndc11
    7133517421
    30 TABLET, FILM COATED in 1 BOTTLE (71335-1742-1)
  • ndc11
    7133517422
    60 TABLET, FILM COATED in 1 BOTTLE (71335-1742-2)
  • ndc11
    7133517423
    90 TABLET, FILM COATED in 1 BOTTLE (71335-1742-3)
  • ndc11
    7133517424
    120 TABLET, FILM COATED in 1 BOTTLE (71335-1742-4)
  • ndc11
    7133517425
    20 TABLET, FILM COATED in 1 BOTTLE (71335-1742-5)
  • ndc11
    7133517426
    40 TABLET, FILM COATED in 1 BOTTLE (71335-1742-6)
  • ndc11
    7133517427
    100 TABLET, FILM COATED in 1 BOTTLE (71335-1742-7)
  • ndc11
    7133517428
    15 TABLET, FILM COATED in 1 BOTTLE (71335-1742-8)

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": "71335-1742_c3c5af52-f6d0-43f9-8adf-c046a433c4db",
  "productndc": "71335-1742",
  "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

Other records sharing ATC code N02BE.

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