Tramadol Hydrochloride

Orange BookUNIISPLATC N02AX02

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

Identification

ManufacturerST. MARY'S MEDICAL PARK PHARMACY

CountryUS (United States)

ATC codeN02AX02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 8

ndc11
6076072709
9 TABLET in 1 BOTTLE, PLASTIC (60760-727-09)
ndc11
6076072720
20 TABLET in 1 BOTTLE, PLASTIC (60760-727-20)
ndc11
6076072730
30 TABLET in 1 BOTTLE, PLASTIC (60760-727-30)
ndc11
6076072750
50 TABLET in 1 BOTTLE, PLASTIC (60760-727-50)
ndc11
6076072760
60 TABLET in 1 BOTTLE, PLASTIC (60760-727-60)
ndc11
6076072790
90 TABLET in 1 BOTTLE, PLASTIC (60760-727-90)
ndc11
6076072792
120 TABLET in 1 BOTTLE, PLASTIC (60760-727-92)
ndc11
6076072798
180 TABLET in 1 BOTTLE, PLASTIC (60760-727-98)

Annotations

UNII (FDA Substance ID)

9N7R477WCK

TRAMADOL HYDROCHLORIDE

RxCUI 82110

Orange Book

A075968

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": "60760-727_4b9860c4-208c-30bc-e063-6294a90a5b71",
  "productndc": "60760-727",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "075968",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Jun 25, 2002"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "002",
        "approval_date": "Aug 2, 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": "ANDA075968",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tramadol Hydrochloride",
  "start_marketing_date": "20240805",
  "active_numerator_strength": "50"
}

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