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
7133596580
50 TABLET, COATED in 1 BOTTLE (71335-9658-0)
ndc11
7133596581
30 TABLET, COATED in 1 BOTTLE (71335-9658-1)
ndc11
7133596582
20 TABLET, COATED in 1 BOTTLE (71335-9658-2)
ndc11
7133596583
90 TABLET, COATED in 1 BOTTLE (71335-9658-3)
ndc11
7133596584
60 TABLET, COATED in 1 BOTTLE (71335-9658-4)
ndc11
7133596585
120 TABLET, COATED in 1 BOTTLE (71335-9658-5)
ndc11
7133596586
180 TABLET, COATED in 1 BOTTLE (71335-9658-6)
ndc11
7133596587
40 TABLET, COATED in 1 BOTTLE (71335-9658-7)
ndc11
7133596588
100 TABLET, COATED in 1 BOTTLE (71335-9658-8)
ndc11
7133596589
15 TABLET, COATED in 1 BOTTLE (71335-9658-9)

Annotations

UNII (FDA Substance ID)

9N7R477WCK

TRAMADOL HYDROCHLORIDE

RxCUI 82110

Orange Book

A208708

ABABAB

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": "71335-9658_7153f206-8ea3-4cc7-9ce3-733bc1712d2f",
  "productndc": "71335-9658",
  "dosage_form": "TABLET, COATED",
  "orange_book": {
    "appl_no": "208708",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Jun 28, 2019"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "002",
        "approval_date": "Jun 28, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "003",
        "approval_date": "Nov 27, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "75MG",
        "product_no": "004",
        "approval_date": "Apr 4, 2024"
      }
    ],
    "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": "ANDA208708",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tramadol Hydrochloride",
  "start_marketing_date": "20230724",
  "active_numerator_strength": "50"
}

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