Tramadol Hydrochloride

Orange BookUNIISPLATC N02AX02

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

Identification

ManufacturerNuCare Pharmaceuticals,Inc.

CountryUS (United States)

ATC codeN02AX02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 8

ndc11
6807141191
120 TABLET, COATED in 1 BOTTLE (68071-4119-1)
ndc11
6807141193
30 TABLET, COATED in 1 BOTTLE (68071-4119-3)
ndc11
6807141194
40 TABLET, COATED in 1 BOTTLE (68071-4119-4)
ndc11
6807141195
15 TABLET, COATED in 1 BOTTLE (68071-4119-5)
ndc11
6807141196
60 TABLET, COATED in 1 BOTTLE (68071-4119-6)
ndc11
6807141197
84 TABLET, COATED in 1 BOTTLE (68071-4119-7)
ndc11
6807141198
180 TABLET, COATED in 1 BOTTLE (68071-4119-8)
ndc11
6807141199
90 TABLET, COATED in 1 BOTTLE (68071-4119-9)

Annotations

UNII (FDA Substance ID)

9N7R477WCK

TRAMADOL HYDROCHLORIDE

RxCUI 82110

Orange Book

A076003

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "9N7R477WCK",
    "rxcui": "82110",
    "inchikey": "PPKXEPBICJTCRU-XMZRARIVSA-N;PPKXEPBICJTCRU-KUARMEPBSA-N",
    "display_name": "TRAMADOL HYDROCHLORIDE",
    "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": "68071-4119_2d3fca70-2bc9-7bec-e063-6294a90a8da4",
  "productndc": "68071-4119",
  "dosage_form": "TABLET, COATED",
  "orange_book": {
    "appl_no": "076003",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Jun 20, 2002"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TRAMADOL HYDROCHLORIDE",
  "proprietary_name": "Tramadol Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA076003",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tramadol Hydrochloride",
  "start_marketing_date": "20101115",
  "active_numerator_strength": "50"
}

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