Tramadol Hydrochloride

Orange BookUNIISPLATC N02AX02

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

Identification

ManufacturerAsclemed USA, Inc.

CountryUS (United States)

ATC codeN02AX02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 8

ndc11
8706311701
100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (87063-117-01)
ndc11
8706311705
500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (87063-117-05)
ndc11
8706311710
10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (87063-117-10)
ndc11
8706311720
20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (87063-117-20)
ndc11
8706311730
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (87063-117-30)
ndc11
8706311750
50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (87063-117-50)
ndc11
8706311760
60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (87063-117-60)
ndc11
8706311790
90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (87063-117-90)

Annotations

UNII (FDA Substance ID)

9N7R477WCK

TRAMADOL HYDROCHLORIDE

RxCUI 82110

Orange Book

A211825

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": "87063-117_4aea6bdc-3282-556d-e063-6394a90afb0c",
  "productndc": "87063-117",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "211825",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Aug 9, 2019"
      }
    ],
    "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": "ANDA211825",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tramadol Hydrochloride",
  "start_marketing_date": "20190809",
  "active_numerator_strength": "50"
}

Related drugs

Other records sharing ATC code N02AX02.

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