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United States · US · US:67457-163_ddecdc4b-0bd4-4b20-a0ac-3c0fa542c14f
Sotradecol
Orange BookUNII
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMylan Institutional LLC
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1167457163025 VIAL, MULTI-DOSE in 1 CARTON (67457-163-02) / 2 mL in 1 VIAL, MULTI-DOSE (67457-163-00)
Annotations
UNII (FDA Substance ID)
6326W0DRHY
TETRADECYL HYDROGEN SULFATE (ESTER)
RxCUI 1370424
Orange Book
A040541
AP
Raw payload (JSON)
{
"unii": {
"unii": "6326W0DRHY",
"rxcui": "1370424",
"inchikey": "GROJOWHVXQYQGN-UHFFFAOYSA-N",
"display_name": "TETRADECYL HYDROGEN SULFATE (ESTER)",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"productid": "67457-163_ddecdc4b-0bd4-4b20-a0ac-3c0fa542c14f",
"productndc": "67457-163",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "040541",
"products": [
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "20MG/2ML (10MG/ML)",
"product_no": "001",
"approval_date": "Nov 12, 2004"
},
{
"rs": true,
"rld": false,
"te_code": "AP",
"strength": "60MG/2ML (30MG/ML)",
"product_no": "002",
"approval_date": "Nov 12, 2004"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TETRADECYL HYDROGEN SULFATE (ESTER)",
"proprietary_name": "Sotradecol",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA040541",
"marketing_category": "ANDA",
"nonproprietary_name": "tetradecyl hydrogen sulfate (ester)",
"start_marketing_date": "20130429",
"active_numerator_strength": "30"
}Access this data programmatically
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