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United States · US · US:83634-603_fae91f1b-7be7-4f48-9541-ee9f2a56a40a
Propofol
Orange BookUNIISPLATC N01AX10
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAvenacy, LLC
CountryUS (United States)
ATC codeN01AX10
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11836346032020 VIAL in 1 CARTON (83634-603-20) / 20 mL in 1 VIAL (83634-603-41)
- ndc11836346035020 VIAL in 1 CARTON (83634-603-50) / 50 mL in 1 VIAL (83634-603-42)
- ndc11836346035110 VIAL in 1 CARTON (83634-603-51) / 100 mL in 1 VIAL (83634-603-43)
Annotations
UNII (FDA Substance ID)
YI7VU623SF
PROPOFOL
RxCUI 8782
Orange Book
A206408
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "YI7VU623SF",
"rxcui": "8782",
"inchikey": "OLBCVFGFOZPWHH-UHFFFAOYSA-N",
"display_name": "PROPOFOL",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"9ba70032-40c2-41c5-9f99-d1f94032d3dc": {
"match": "brand_token",
"title": "PROPOFOL INJECTION, EMULSION [CIVICA, INC]",
"spl_version": "7",
"published_date": "2026-05-20"
}
},
"productid": "83634-603_fae91f1b-7be7-4f48-9541-ee9f2a56a40a",
"productndc": "83634-603",
"dosage_form": "INJECTION, EMULSION",
"orange_book": {
"appl_no": "206408",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG/ML",
"product_no": "001",
"approval_date": "Oct 12, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PROPOFOL",
"proprietary_name": "Propofol",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA206408",
"marketing_category": "ANDA",
"nonproprietary_name": "propofol",
"start_marketing_date": "20250330",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code N01AX10.
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