TRAMADOL HYDROCHLORIDE

Orange BookUNIISPLATC N02AX02

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

Identification

ManufacturerPreferred Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeN02AX02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
6878876012
20 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7601-2)
ndc11
6878876013
30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7601-3)
ndc11
6878876016
60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7601-6)
ndc11
6878876019
90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7601-9)

Annotations

UNII (FDA Substance ID)

9N7R477WCK

TRAMADOL HYDROCHLORIDE

RxCUI 82110

Orange Book

A200503

AB1AB1AB1

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": "68788-7601_002cc3ab-993f-4e80-a885-c07bfd4b5dc1",
  "productndc": "68788-7601",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "200503",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB1",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Aug 29, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "200MG",
        "product_no": "002",
        "approval_date": "Aug 29, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "300MG",
        "product_no": "003",
        "approval_date": "Aug 29, 2011"
      }
    ],
    "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": "ANDA200503",
  "marketing_category": "ANDA",
  "nonproprietary_name": "TRAMADOL HYDROCHLORIDE",
  "start_marketing_date": "20200206",
  "active_numerator_strength": "200"
}

Related drugs

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