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United States · US · US:80830-1188_37f0add8-759a-4ec9-a147-edef685124e5
PROPOFOL
Orange BookUNIISPLATC N01AX10
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals Private Limited
CountryUS (United States)
ATC codeN01AX10
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11808301188710 VIAL in 1 CARTON (80830-1188-7) / 20 mL in 1 VIAL (80830-1188-1)
Annotations
UNII (FDA Substance ID)
YI7VU623SF
PROPOFOL
RxCUI 8782
Orange Book
A217525
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": "80830-1188_37f0add8-759a-4ec9-a147-edef685124e5",
"productndc": "80830-1188",
"dosage_form": "INJECTION, EMULSION",
"orange_book": {
"appl_no": "217525",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG/ML",
"product_no": "001",
"approval_date": "Aug 15, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PROPOFOL",
"proprietary_name": "PROPOFOL",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA217525",
"marketing_category": "ANDA",
"nonproprietary_name": "propofol",
"start_marketing_date": "20240816",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code N01AX10.
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