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United States · US · US:69238-2348_267b7da8-2e24-4130-92d5-98d6da176ed6
Tramadol Hydrochloride
Orange BookUNIISPLATC N02AX02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals NY LLC
CountryUS (United States)
ATC codeN02AX02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc116923823481100 TABLET, COATED in 1 BOTTLE (69238-2348-1)
- ndc11692382348410 TABLET, COATED in 1 BOTTLE (69238-2348-4)
- ndc116923823485500 TABLET, COATED in 1 BOTTLE (69238-2348-5)
- ndc1169238234871000 TABLET, COATED in 1 BOTTLE (69238-2348-7)
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": "69238-2348_267b7da8-2e24-4130-92d5-98d6da176ed6",
"productndc": "69238-2348",
"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 Hydrochloride",
"active_ingred_unit": "mg/1",
"application_number": "ANDA076003",
"marketing_category": "ANDA",
"nonproprietary_name": "Tramadol Hydrochloride",
"start_marketing_date": "20101115",
"active_numerator_strength": "50"
}Related drugs
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- BEContramal 100 mgGrunenthal
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