Tapentadol Hydrochloride

Orange BookUNIISPLATC N02AX06

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerEPIC PHARMA LLC

CountryUS (United States)

ATC codeN02AX06

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4280662801
100 TABLET, FILM COATED in 1 BOTTLE (42806-628-01)

Annotations

UNII (FDA Substance ID)

71204KII53

TAPENTADOL HYDROCHLORIDE

RxCUI 857492

Orange Book

A214378

ABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "71204KII53",
    "rxcui": "857492",
    "inchikey": "ZELFLGGRLLOERW-YECZQDJWSA-N",
    "display_name": "TAPENTADOL HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "863f3fd3-1e8d-41b0-855f-8f9a29237cda": {
      "match": "brand_token",
      "title": "TAPENTADOL (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [HIKMA PHARMACEUTICALS USA INC.]",
      "spl_version": "2",
      "published_date": "2026-03-05"
    }
  },
  "productid": "42806-628_120aa46b-8c91-4460-8e91-85cbaac53d20",
  "productndc": "42806-628",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "214378",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 50MG BASE",
        "product_no": "001",
        "approval_date": "Jan 27, 2026"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 75MG BASE",
        "product_no": "002",
        "approval_date": "Jan 27, 2026"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 100MG BASE",
        "product_no": "003",
        "approval_date": "Jan 27, 2026"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TAPENTADOL HYDROCHLORIDE",
  "proprietary_name": "Tapentadol Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA214378",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tapentadol Hydrochloride",
  "start_marketing_date": "20211231",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code N02AX06.

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