TRAMADOL HYDROCHLORIDE

Orange BookUNIISPLATC N02AX02

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

Identification

ManufacturerSun Pharmaceutical Industries, Inc.

CountryUS (United States)

ATC codeN02AX02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
4733586108
100 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-861-08)
ndc11
4733586118
1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-861-18)
ndc11
4733586183
30 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-861-83)
ndc11
4733586188
100 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-861-88)

Annotations

UNII (FDA Substance ID)

9N7R477WCK

TRAMADOL HYDROCHLORIDE

RxCUI 82110

Orange Book

A201384

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": "47335-861_a994e116-d201-47f9-baaf-dd76a84eba7e",
  "productndc": "47335-861",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "201384",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Dec 7, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "200MG",
        "product_no": "002",
        "approval_date": "Dec 7, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "300MG",
        "product_no": "003",
        "approval_date": "Dec 7, 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": "ANDA201384",
  "marketing_category": "ANDA",
  "nonproprietary_name": "TRAMADOL HYDROCHLORIDE",
  "start_marketing_date": "20111212",
  "active_numerator_strength": "300"
}

Related drugs

Other records sharing ATC code N02AX02.

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