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United States · US · US:71335-0111_1c50d830-dc13-481d-b224-0260a6447d12

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
    7133501111
    30 TABLET in 1 BOTTLE (71335-0111-1)
  • ndc11
    7133501112
    60 TABLET in 1 BOTTLE (71335-0111-2)
  • ndc11
    7133501113
    90 TABLET in 1 BOTTLE (71335-0111-3)
  • ndc11
    7133501114
    120 TABLET in 1 BOTTLE (71335-0111-4)
  • ndc11
    7133501115
    20 TABLET in 1 BOTTLE (71335-0111-5)
  • ndc11
    7133501116
    40 TABLET in 1 BOTTLE (71335-0111-6)
  • ndc11
    7133501117
    100 TABLET in 1 BOTTLE (71335-0111-7)
  • ndc11
    7133501118
    15 TABLET in 1 BOTTLE (71335-0111-8)

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": "71335-0111_1c50d830-dc13-481d-b224-0260a6447d12",
  "productndc": "71335-0111",
  "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

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