tramadol hydrochloride

Orange BookUNIISPLATC N02AX02

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

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC codeN02AX02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 10

ndc11
7133525180
50 TABLET in 1 BOTTLE (71335-2518-0)
ndc11
7133525181
30 TABLET in 1 BOTTLE (71335-2518-1)
ndc11
7133525182
20 TABLET in 1 BOTTLE (71335-2518-2)
ndc11
7133525183
90 TABLET in 1 BOTTLE (71335-2518-3)
ndc11
7133525184
60 TABLET in 1 BOTTLE (71335-2518-4)
ndc11
7133525185
120 TABLET in 1 BOTTLE (71335-2518-5)
ndc11
7133525186
180 TABLET in 1 BOTTLE (71335-2518-6)
ndc11
7133525187
40 TABLET in 1 BOTTLE (71335-2518-7)
ndc11
7133525188
100 TABLET in 1 BOTTLE (71335-2518-8)
ndc11
7133525189
15 TABLET in 1 BOTTLE (71335-2518-9)

Annotations

UNII (FDA Substance ID)

9N7R477WCK

TRAMADOL HYDROCHLORIDE

RxCUI 82110

Orange Book

A202075

ABAB

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": "71335-2518_e37a5865-f78e-41d4-9d0a-b7ec7bcd0807",
  "productndc": "71335-2518",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "202075",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Nov 28, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "002",
        "approval_date": "Mar 23, 2026"
      }
    ],
    "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": "ANDA202075",
  "marketing_category": "ANDA",
  "nonproprietary_name": "tramadol hydrochloride",
  "start_marketing_date": "20180301",
  "active_numerator_strength": "50"
}

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