tramadol hydrochloride

Orange BookUNIISPLATC N02AX02

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

Identification

ManufacturerRedPharm Drug, Inc.

CountryUS (United States)

ATC codeN02AX02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 7

ndc11
6729610211
10 TABLET in 1 BOTTLE (67296-1021-1)
ndc11
6729610212
20 TABLET in 1 BOTTLE (67296-1021-2)
ndc11
6729610213
30 TABLET in 1 BOTTLE (67296-1021-3)
ndc11
6729610214
45 TABLET in 1 BOTTLE (67296-1021-4)
ndc11
6729610215
15 TABLET in 1 BOTTLE (67296-1021-5)
ndc11
6729610216
6 TABLET in 1 BOTTLE (67296-1021-6)
ndc11
6729610217
40 TABLET in 1 BOTTLE (67296-1021-7)

Annotations

UNII (FDA Substance ID)

9N7R477WCK

TRAMADOL HYDROCHLORIDE

RxCUI 82110

Orange Book

A075964

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": "67296-1021_1cfead90-c8e9-3bb3-e063-6394a90a1090",
  "productndc": "67296-1021",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "075964",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Jun 19, 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": "ANDA075964",
  "marketing_category": "ANDA",
  "nonproprietary_name": "tramadol hydrochloride",
  "start_marketing_date": "20020622",
  "active_numerator_strength": "50"
}

Related drugs

Other records sharing ATC code N02AX02.

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