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United States · US · US:43598-548_b4a9147e-dfe3-229a-d8d7-6a84e6449f15
Propofol Injectable Emulsion
Orange BookUNIISPLATC N01AX10
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDr. Reddy's Laboratories, Inc.
CountryUS (United States)
ATC codeN01AX10
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11435985482120 VIAL in 1 CARTON (43598-548-21) / 50 mL in 1 VIAL (43598-548-50)
Annotations
UNII (FDA Substance ID)
YI7VU623SF
PROPOFOL
RxCUI 8782
Orange Book
A205067
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": "43598-548_b4a9147e-dfe3-229a-d8d7-6a84e6449f15",
"productndc": "43598-548",
"dosage_form": "INJECTION, EMULSION",
"orange_book": {
"appl_no": "205067",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG/ML",
"product_no": "001",
"approval_date": "Nov 15, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PROPOFOL",
"proprietary_name": "Propofol Injectable Emulsion",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA205067",
"marketing_category": "ANDA",
"nonproprietary_name": "Propofol Injectable Emulsion",
"start_marketing_date": "20181115",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code N01AX10.
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