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United States · US · US:80425-0057_2a98da36-e8b2-759b-e063-6294a90ab33b
Tramadol HCL
Orange BookUNIISPLATC N02AX02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAdvanced Rx of Tennessee, LLC
CountryUS (United States)
ATC codeN02AX02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc11804250057130 TABLET, COATED in 1 BOTTLE (80425-0057-1)
- ndc11804250057260 TABLET, COATED in 1 BOTTLE (80425-0057-2)
- ndc11804250057390 TABLET, COATED in 1 BOTTLE (80425-0057-3)
- ndc11804250057415 TABLET, COATED in 1 BOTTLE (80425-0057-4)
- ndc118042500575120 TABLET, COATED in 1 BOTTLE (80425-0057-5)
Annotations
UNII (FDA Substance ID)
9N7R477WCK
TRAMADOL HYDROCHLORIDE
RxCUI 82110
Orange Book
A076003
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": "80425-0057_2a98da36-e8b2-759b-e063-6294a90ab33b",
"productndc": "80425-0057",
"dosage_form": "TABLET, COATED",
"orange_book": {
"appl_no": "076003",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "001",
"approval_date": "Jun 20, 2002"
}
],
"appl_type": "A"
},
"dea_schedule": "CIV",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TRAMADOL HYDROCHLORIDE",
"proprietary_name": "Tramadol HCL",
"active_ingred_unit": "mg/1",
"application_number": "ANDA076003",
"marketing_category": "ANDA",
"nonproprietary_name": "Tramadol HCL",
"start_marketing_date": "20101115",
"active_numerator_strength": "50"
}Related drugs
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- BEContramal 100 mgGrunenthal
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