Home NDC 83854-018 PROPOFOL
Product NDC 83854-018
11-digit product format 838540018
Labeler code 83854
Product ID 83854-018_56a34840-59c8-80f2-e063-6294a90a64a7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PROPOFOL
Dosage form INJECTION, EMULSION
Route INTRAVENOUS
Labeler Anthea Pharma Private Limited
Application ANDA220857
Marketing category ANDA
Marketing start 2026-07-14
Substance PROPOFOL
Active strength 10 mg/mL
Pharmacologic classes General Anesthesia [PE]; General Anesthetic [EPC]
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog .
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base PROPOFOL
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PROPOFOL 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination YI7VU623SF Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1808224 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Status 83854-018-10 83854001810 10 VIAL in 1 CARTON (83854-018-10) / 20 mL in 1 VIAL (83854-018-01) 10 vial 2026-07-14 0 Current