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United States · US · US:57664-762_48471dc2-bdd9-2263-e063-6294a90a9e03
Levorphanol Tartrate
Orange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc115766476288100 TABLET in 1 BOTTLE (57664-762-88)
Annotations
UNII (FDA Substance ID)
04WQU6T9QI
LEVORPHANOL TARTRATE
RxCUI 153973
Orange Book
A213906
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "04WQU6T9QI",
"rxcui": "153973",
"inchikey": "UMZNDVASJKIQCB-QLFXFZCRSA-N",
"display_name": "LEVORPHANOL TARTRATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"759c7040-0be0-4d17-be97-e467e423eaa8": {
"match": "brand_token",
"title": "LEVORPHANOL TARTRATE TABLET [SPECGX LLC]",
"spl_version": "18",
"published_date": "2026-05-01"
}
},
"productid": "57664-762_48471dc2-bdd9-2263-e063-6294a90a9e03",
"productndc": "57664-762",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "213906",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "2MG",
"product_no": "001",
"approval_date": "Jun 17, 2021"
},
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "3MG",
"product_no": "002",
"approval_date": "Apr 25, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": "CII",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LEVORPHANOL TARTRATE",
"proprietary_name": "Levorphanol Tartrate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA213906",
"marketing_category": "ANDA",
"nonproprietary_name": "Levorphanol Tartrate",
"start_marketing_date": "20220426",
"active_numerator_strength": "2"
}Access this data programmatically
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