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United States · US · US:50090-5789_d2130333-f392-4f3c-b988-c4147c6c9595

Tramadol Hydrochloride

Orange BookUNIISPLATC N02AX02

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeN02AX02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 6

  • ndc11
    5009057890
    30 TABLET, FILM COATED in 1 BOTTLE (50090-5789-0)
  • ndc11
    5009057891
    20 TABLET, FILM COATED in 1 BOTTLE (50090-5789-1)
  • ndc11
    5009057892
    50 TABLET, FILM COATED in 1 BOTTLE (50090-5789-2)
  • ndc11
    5009057894
    15 TABLET, FILM COATED in 1 BOTTLE (50090-5789-4)
  • ndc11
    5009057895
    60 TABLET, FILM COATED in 1 BOTTLE (50090-5789-5)
  • ndc11
    5009057899
    120 TABLET, FILM COATED in 1 BOTTLE (50090-5789-9)

Annotations

UNII (FDA Substance ID)
9N7R477WCK
TRAMADOL HYDROCHLORIDE
RxCUI 82110
Orange Book
A211825
AB
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": "50090-5789_d2130333-f392-4f3c-b988-c4147c6c9595",
  "productndc": "50090-5789",
  "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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