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United States · US · US:64380-778_c2d5dbfb-34d9-409a-a365-5f9e1f23d33f
tramadol hydrochloride
Orange BookUNIISPLATC N02AX02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerStrides Pharma Science Limited
CountryUS (United States)
ATC codeN02AX02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11643807780130 TABLET in 1 BOTTLE (64380-778-01)
Annotations
UNII (FDA Substance ID)
9N7R477WCK
TRAMADOL HYDROCHLORIDE
RxCUI 82110
Orange Book
A202075
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": "64380-778_c2d5dbfb-34d9-409a-a365-5f9e1f23d33f",
"productndc": "64380-778",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "202075",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "001",
"approval_date": "Nov 28, 2011"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "25MG",
"product_no": "002",
"approval_date": "Mar 23, 2026"
}
],
"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": "ANDA202075",
"marketing_category": "ANDA",
"nonproprietary_name": "tramadol hydrochloride",
"start_marketing_date": "20260601",
"active_numerator_strength": "25"
}Related drugs
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